Nutrilite Veggie 150 Omega Complex by Access Business Group LLC

POSSIBLY EFFECTIVE

• Preterm labor. Most research shows that taking oral docosahexaenoic acid (DHA)-enriched algal oil seems to prevent preterm labor in those with low DHA status at baseline. Details: A large clinical trial shows that taking algal oil (Life's DHA) 2 grams, providing DHA 1000 mg daily during pregnancy, starting at 12-20 weeks' gestation and continuing until delivery, results in an early preterm birth rate of 1.7%, compared with 2.4% in those taking algal oil providing DHA 200 mg daily. Benefits were strongest in those with low DHA status at baseline, with no benefit in those with high DHA status at baseline and in those with high adherence to DHA 1000 mg daily (109204,110360). A secondary analysis of two studies shows that taking algal oil providing DHA 800 mg modestly reduces the early preterm and preterm birth rates in those with a low DHA status at baseline compared with taking algal oil providing DHA 200 mg (110361).

POSSIBLY INEFFECTIVE

• Cognitive function. Oral docosahexaenoic acid (DHA)-enriched algal oil does not seem to improve cognitive function in most children. Details: In healthy children aged 7-12 years in rural China, clinical research shows that taking DHA-enriched algal oil 800 mg daily for 6 months does not improve measures of executive function when compared with placebo (104560). In addition, although some clinical research shows that taking DHA-enriched algal oil 1500 mg daily for 16 weeks improves reading scores when compared with placebo in a subgroup of children ages 6-10 years who are below the 20th percentile for reading (90699), these results could not be replicated in a later study that included only children below the 20th percentile for reading (98542). The reason for this particular discrepancy is not clear. Both trials were conducted by the same researchers in a similar area of the UK. However, the methods for both reading instruction and proficiency changed in the time between these trials. Nevertheless, taking DHA-enriched algal oil does not appear to improve reading scores in children at or above the 20th percentile for reading, and there does not appear to be any benefit of algal oil on working memory in children (90699).
• Cystic fibrosis. Most research shows that oral docosahexaenoic acid (DHA)-enriched algal oil does not improve symptoms of cystic fibrosis. Details: Clinical research in infants, children, and young adults with cystic fibrosis shows that taking algal oil (DHA-basic, CASEN Fleet SLU) providing DHA 50 mg/kg daily for 48 weeks does not improve spirometry measures, reduce Pseudomonas aeruginosa primary infections, or reduce the number of, or time to, total or severe pulmonary exacerbations when compared with placebo (109217). Also, small clinical studies show that taking algal oil providing DHA 70 mg/kg daily for 6 weeks, or 100 mg/kg daily for one month and then 1 gram daily for 11 months, does not improve lung function or overall health in patients with cystic fibrosis (48119,90665).
• Fractures. Taking oral algal oil as a source of omega-3 fatty acids does not seem to prevent fractures in older adults. Details: A large clinical study shows that taking omega-3 fatty acids 1 gram daily from algal oil, providing 330 mg of eicosapentaenoic acid (EPA) and 660 mg of docosahexaenoic acid (DHA), does not prevent fractures in adults over 70 years of age when compared with placebo. These findings were consistent in adults taking omega-3 fatty acids alone, or with vitamin D 2000 IU daily and/or with strength training three times weekly (104619).
• Physical performance. Taking oral algal oil as a source of omega-3 fatty acids does not seem to improve muscle strength in older adults. Details: A large clinical study shows that taking omega-3 fatty acids 1 gram daily from algal oil, providing 330 mg of eicosapentaenoic acid (EPA) and 660 mg of docosahexaenoic acid (DHA), does not improve muscle strength in adults over 70 years of age when compared with placebo. These findings were consistent in adults taking omega-3 fatty acids alone, or with vitamin D 2000 IU daily and/or with strength training three times weekly (104619).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Age-related cognitive decline. It is unclear if oral algal oil is beneficial for age-related cognitive decline. Details: One large clinical study in adults with age-related cognitive decline shows that taking docosahexaenoic acid (DHA)-enriched algal oil providing DHA 900 mg daily for 24 weeks improves episodic memory and visuospatial learning when compared with placebo. However, working memory and executive function are not improved (90717). Conversely, a large clinical study in adults over 70 years of age shows that taking omega-3 fatty acids 1 gram daily from algal oil, providing 330 mg of eicosapentaenoic acid (EPA) and 660 mg of docosahexaenoic acid (DHA), does not improve Montreal cognitive assessment (MoCA) scores when compared with placebo. These findings were consistent in adults taking omega-3 fatty acids alone, or with vitamin D 2000 IU daily and/or with strength training three times weekly (104619).
• Attention deficit-hyperactivity disorder (ADHD). Although there is interest in using oral algal oil for ADHD, there is insufficient reliable information about the clinical effects of algal oil for this condition.
• Autism spectrum disorder. Although there is interest in using oral algal oil for autism spectrum disorder, there is insufficient reliable information about the clinical effects of algal oil for this condition.
• Bronchopulmonary dysplasia. It is unclear if oral docosahexaenoic acid (DHA)-enriched algal oil is beneficial for preventing bronchopulmonary dysplasia (BPD) in very premature infants. Details: Clinical research shows that taking algal oil providing DHA 1.2 grams daily while breastfeeding, starting within 72 hours of delivery of infants born before 29 weeks' gestation, has no effect on mortality of breastfed infants or on survival without BPD at 36 weeks postmenstrual age. However, the occurrence of BPD in infants in the algal oil group was INCREASED when compared with those in the placebo group (104559). The conclusions of this study are limited by its early termination. In addition, about half of the infants in both groups received intravenous DHA-rich lipids per standard of clinical care. Also, more infants in the algal oil group were born via cesarean delivery, further confounding these findings.
• Cancer. Although there is interest in using oral algal oil for cancer prevention, there is insufficient reliable information about the clinical effects of algal oil for this purpose.
• Coronary heart disease (CHD). It is unclear if oral oleic acid-enriched algal oil is beneficial for CHD prevention. Details: Some algal oil products contain high quantities of oleic acid. In 2018, the US Food and Drug Administration (FDA) determined that it would allow a qualified health claim stating that consuming 1.5 tablespoons daily of oils containing at least 70% oleic acid may reduce the risk of CHD. In order to obtain any benefit, this oil must be used to replace fats and oils higher in saturated fat. However, the FDA has determined that this statement is based on supporting, rather than conclusive, evidence (98563).
• Depression. Although there is interest in using oral algal oil for depression, there is insufficient reliable information about the clinical effects of algal oil for this condition.
• Hyperlipidemia. It is unclear if oral algal oil is beneficial for hyperlipidemia. Details: A meta-analysis of 11 randomized controlled trials involving 485 healthy adults shows that taking docosahexaenoic acid (DHA)-enriched algal oil, providing a median DHA dose of 1.68 grams, daily for 6 weeks reduces triglycerides by 15% and increases high-density lipoprotein (HDL) cholesterol by 5% when compared with placebo oils. However, low-density lipoprotein (LDL) cholesterol modestly increased by 8% (90669). The effect of DHA-enriched algal oil on blood lipids or cardiovascular outcomes in patients with heart disease or hyperlipidemia is unknown. In individuals with borderline or true hypercholesterolemia, a small clinical trial shows that taking an eicosapentaenoic acid (EPA)-enriched algal oil (AlmegaPL) 1 gram daily for 12 weeks modestly reduces levels of total cholesterol and non-HDL cholesterol, but has no effect on triglyceride or LDL cholesterol levels (103314).
• Hypertension. It is unclear if oral algal oil as a source of omega-3 fatty acids is beneficial for hypertension. Details: A large clinical study shows that taking omega-3 fatty acids 1 gram daily from algal oil, providing 330 mg of eicosapentaenoic acid (EPA) and 660 mg of docosahexaenoic acid (DHA), does not reduce blood pressure in adults over 70 years of age, some of whom had self-reported hypertension, when compared with placebo. These findings were consistent in adults taking omega-3 fatty acids alone, or with vitamin D 2000 IU daily and/or with strength training three times weekly (104619).
• Infant development. It is unclear if oral docosahexaenoic acid (DHA)-enriched algal oil can improve infant development. Details: Clinical research shows that taking DHA-enriched algal oil (DHASCO, Martek Biosciences Corp.) 500 mg daily for 4 months while breastfeeding, beginning within 5 days of delivery, does not improve visual function of the breastfed infant at 4 or 8 months of age or neurodevelopment by the age of one year. However, it might slightly improve fine and gross motor development at age 30 months and sustained attention at the age of 5 years (48095,48285,96522).
• Necrotizing enterocolitis (NEC). It is unclear if oral docosahexaenoic acid (DHA)-enriched algal oil is beneficial for preventing NEC in very premature infants. Details: Preliminary clinical research shows that taking algal oil providing DHA 1.2 grams daily while breastfeeding, starting within 72 hours of delivery of infants born before 29 weeks' gestation, has no effect on the incidence of NEC in breastfeed infants at 36 weeks postmenstrual age when compared with placebo (104559).
• Nonalcoholic fatty liver disease (NAFLD). Although there is interest in using algal oil for NAFLD, there is insufficient reliable information about the clinical effects of algal oil for this condition.
• Osteopenia. It is unclear if oral docosahexaenoic acid (DHA)-enriched algal oil is beneficial for osteopenia. Details: Preliminary clinical research shows that taking two capsules daily of algal oil (Life'sDHA) in combination with calcium 1200 mg and vitamin D 1000 IU does not improve bone mass in females with osteopenia when compared with calcium and vitamin D alone (98547).
• Prematurity. It is unclear if oral docosahexaenoic acid (DHA)-enriched algal oil during lactation or early in infancy is beneficial for increasing growth or neurodevelopment of the premature infant. Details: Clinical research in lactating individuals who delivered prior to 29 weeks' gestation shows that taking algal oil providing DHA 1.2 grams daily, starting within 72 hours of delivery and continuing until the infant reached 36 weeks postmenstrual age, might have beneficial effects on the growth of female infants, but not male infants, when compared with placebo. Weight velocity and weight gain were significantly increased in the female infants, with a weight gain of 52.6 grams. However, weight gain and weight velocity were not improved in the male infants, and weight at 36 weeks postmenstrual age was 89 grams less than those whose mothers took placebo (109221). In addition, there was no improvement in neurodevelopmental outcomes at 18 to 22 months corrected age (110364).
• Retinitis pigmentosa. It is unclear if oral docosahexaenoic acid (DHA)-enriched algal oil is beneficial for retinitis pigmentosa. Details: A small clinical study in males with X-linked retinitis pigmentosa shows that taking algal oil providing DHA 30 mg/kg daily for 4 years does not slow the loss of cone or rod electroretinography function (90683). However, a report of ancillary outcomes from this study shows that taking DHA might slow the rate of decline in final dark-adapted thresholds and visual field sensitivity in these patients (95738).
• Retinopathy of prematurity. It is unclear if oral docosahexaenoic acid (DHA)-enriched algal oil is beneficial for preventing retinopathy of prematurity in very premature infants. Details: Preliminary clinical research shows that taking algal oil providing DHA 1.2 grams daily while breastfeeding, starting within 72 hours of delivery of infants born before 29 weeks' gestation, has no effect on the incidence of retinopathy of prematurity in breastfeed infants at 36 weeks postmenstrual age when compared with placebo (104559).
• Sepsis. It is unclear if oral docosahexaenoic acid (DHA)-enriched algal oil is beneficial for preventing sepsis in very premature infants. Details: Preliminary clinical research shows that taking algal oil providing DHA 1.2 grams daily while breastfeeding, starting within 72 hours of delivery of infants born before 29 weeks' gestation, has no effect on the incidence of sepsis in breastfeed infants at 36 weeks postmenstrual age when compared with placebo (104559). More evidence is needed to rate algal oil for these uses.

(Read more about ALGAL OIL)

POSSIBLY EFFECTIVE

• Constipation. Oral flaxseed is a bulk forming laxative that helps to relieve constipation. Details: Flaxseed is a source of dietary fiber and has a bulk forming laxative effect (6803,12910). One clinical study in healthy young adults shows that consuming muffins containing 25 grams of milled flaxseed twice daily for 4 weeks increases weekly bowel movements by 30% when compared to a control group (6803). Other clinical research in diabetic patients with constipation shows that taking flaxseed 10 grams twice daily for 12 weeks improves stool form and reduces constipation by a moderate amount when compared with placebo (101950). Furthermore, a small clinical study in patients in China with functional constipation shows that consuming brown flaxseed flour 50 grams in divided doses with meals daily for 4 weeks seems to modestly improve frequency of bowel movements and pain and reduce failure to evacuate when compared with taking lactulose 15 mL every morning (105474). Flaxseed has also been evaluated in combination with other natural ingredients. A preliminary clinical trial in elderly patients with mild constipation shows that eating yogurt containing galacto-oligosaccharide syrup (Elixor, Borculo Whey Products) 6 grams, prunes 6 grams, and flaxseed 3 grams twice daily for 3 weeks increases stool frequency when compared with a control yogurt (21191). It is unclear if the effects were due to flaxseed, other constituents, or the combination.
• Diabetes. Oral ground flaxseed modestly reduces blood glucose in patients with diabetes and pre-diabetes. It is unclear if oral whole flaxseed reduces blood glucose. Details: Most evidence from meta-analyses and clinical research in adults with prediabetes and diabetes shows that taking ground flaxseed reduces fasting blood glucose and insulin levels (21194,21196,26479,101950,111061). A meta-analysis of 7 small to moderate clinical trials shows that taking flaxseed, usually ground, 13 to 40 grams daily for 8-12 weeks has a small beneficial effect on fasting blood glucose, insulin, insulin resistance, and glycated hemoglobin (HbA1c), compared with no intervention or another fiber source. A sub-analysis shows that the benefit of flaxseed on fasting glucose levels remains in patients with type 2 diabetes (111061). Other research disagrees. A meta-analysis of three small clinical trials in patients with type 2 diabetes shows that taking flaxseed does not improve fasting blood glucose, insulin resistance, or HbA1c (111062). Another meta-analysis of 24 clinical studies involving 1,879 patients with and without diabetes shows that whole and ground flaxseed seem to reduce blood glucose levels by an average of 6 mg/dL and insulin levels by an average of 1 mIU/mL and modestly reduce insulin resistance when compared with control treatments such as wheat germ or raw rice. Whole and ground flaxseed were not shown to significantly reduce HbA1c when compared with control, although there was a non-significant trend towards a reduction (96428). Significant heterogeneity in study size and study population limit the validity of these findings. The effects of flaxseed lignan extract in patients with type 2 diabetes is unclear. A small clinical study in Chinese adults with type 2 diabetes show that using a specific standardized flaxseed lignan extract (Flax Essence, Jarrow Formulas) 600 mg three times daily, providing 360 mg secoisolariciresinol diglucoside, slightly reduces HbA1c when compared with placebo (16768). However, a small meta-analysis including this study shows that taking flaxseed lignans does not reduce fasting blood glucose or HbA1c (111062).
• Hypercholesterolemia. Oral whole and ground flaxseed modestly reduce lipid levels. Details: Most research shows that taking various flaxseed preparations 30-50 grams daily reduces total cholesterol by 5% to 15% and low-density lipoprotein (LDL) cholesterol by 8% to 18%, but does not seem to affect high-density lipoprotein (HDL) cholesterol, when compared with control (6808,10952,22179,26478,65866,101944,101947,101949,108044,108046)(111064). Apolipoprotein A-1 and apolipoprotein B may be reduced by 6% and 7.5%, respectively (10952). A meta-analysis of clinical studies shows reductions in apolipoprotein A and apolipoprotein B following whole flaxseed supplementation (108046). The cholesterol-lowering effect of flaxseed has been shown in various populations, including those with hypercholesterolemia with/or without diabetes, postmenopausal patients, and patients with chronic kidney disease or cardiovascular risk factors (6808,10952,10978,12910,22180,22181,26478,26480,26488,101944)(101949,101950,111064). One large meta-analysis suggests that the most consistent effect occurs in patients with hypercholesterolemia (101947). Another large meta-analysis suggests that patients with hypercholesterolemia and healthy patients with a body mass index greater than 25 kg/m2 may benefit the most from treatment (108044). Most research shows that flaxseed reduces triglyceride levels (101947,108046,111064). However, there are certain preparations, such as partially defatted flaxseed (which lacks alpha-linolenic acid content) or flaxseed incorporated into bread products, which might increase triglyceride levels by up to 26% (6808,26488).
• Hypertension. Daily oral flaxseed consumption, especially for longer than 12 weeks, seems to modestly reduce blood pressure. Details: Meta-analyses of mainly small clinical studies in patients with and without hypertension show that taking flaxseed reduces systolic and diastolic blood pressure by an average of 1.1 to 1.8 and 1.0 to 1.3 mmHg, respectively, when compared with control (96426,111063). The effect of flaxseed lignan is unclear. One meta-analysis shows that flaxseed lignan does not seem to reduce blood pressure when compared with control (96426). However, a more recent meta-analysis shows that taking flaxseed lignan has a small effect on systolic, but not diastolic, blood pressure (111063). The length of supplementation may play a role as studies lasting longer than 12 weeks seemed to lower blood pressure to a slightly greater degree than studies lasting less than 12 weeks (96426). The validity of these findings is limited due to the short duration of treatment, the variation in study size, the inclusion of patients with and without hypertension, and the range of doses used. Some clinical research also shows that taking flaxseed may be beneficial for blood pressure reduction in patients with hypertension (111063). One individual clinical study in adults with hypertension shows that taking flaxseed 10 grams or 30 grams daily affects blood pressure in a dose-dependent manner when compared with placebo. After 12 weeks of treatment, systolic and diastolic blood pressure decreased by 12 mmHg and 6 mmHg, respectively, in the high-dose group, compared with 10 mmHg and 7 mmHg, respectively, in the low-dose group (108043).
• Mastalgia. Oral flaxseed seems to reduce symptoms of cyclic mastalgia. Details: Clinical research in healthy Iranian women with cyclic mastalgia shows that taking flaxseed powder 25 grams daily for 2 months reduces breast pain intensity from moderate to mild and also reduces duration of pain when compared with placebo (96250). Other preliminary clinical research shows that eating a muffin containing ground flaxseed 25 grams daily for 3 months reduces symptoms of severe cyclic mastalgia (16766).
• Obesity. Oral flaxseed and flaxseed mucilage seem to modestly improve weight loss in patients who are obese or overweight. However, flaxseed lignan extract does not seem to be beneficial. Details: A meta-analysis of 45 clinical studies including 2,561 overweight or obese adults shows that flaxseed consumption reduces body weight by 1.8 kg, body mass index (BMI) by 0.6 kg/m2, and waist circumference by 1.2 cm when compared with control in adults. The most benefit is seen in adults with a baseline BMI greater than or equal to 27 (96427). Flaxseed consumption of at least 30 grams daily for durations of at least 12 weeks demonstrated the greatest efficacy (96427,101949). The soluble fiber, flaxseed mucilage, has also been studied. A clinical trial in overweight or obese adults shows that taking oral flaxseed mucilage 1280 or 2560 mg mixed in water twice daily with meals for 12 weeks decreases body weight, waist circumference, and BMI in a dose-dependent manner when compared with placebo. After 12 weeks, a 5 kg and 4 kg weight reduction was observed in the high- and low-dose groups, respectively, compared to a 1 kg reduction in the placebo group (108047). The validity of this finding is limited due to short duration of treatment and lack of follow-up. Conversely, flaxseed lignan extract does not appear to be effective in reducing weight, BMI, or waist circumference (96427). Some research has investigated whether variants in genes related to satiety and appetite play a role in any effect of flaxseed on weight loss and appetite. A small clinical trial in adults with overweight or obesity shows that taking defatted flaxseed flour in biscuits daily for 8 weeks modestly reduces body weight, BMI, triglycerides, or blood glucose only in those with specific gene variants when compared with control biscuits (111066). More information is needed to determine how these gene variants play a role in the connection between nutrition and obesity.
• Systemic lupus erythematosus (SLE) nephritis. Oral flaxseed might be beneficial for improving kidney function in SLE. Details: Some small clinical studies suggest that taking whole or ground flaxseed orally might improve serum creatinine levels in people with SLE nephritis (6802,8021).

POSSIBLY INEFFECTIVE

• Osteoporosis. Oral flaxseed does not seem to be beneficial in osteoporosis. Details: Clinical research shows that consuming ground flaxseed 40 grams daily for up to one year does not affect markers of bone metabolism or improve bone mineral density in healthy, postmenopausal adults (10952,12910). Similarly, taking flaxseed extract 550 mg three times daily for 6 months does not appear to improve bone mineral density when compared with placebo in older adults (21197).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. Although there is interest in using oral flaxseed for acne, there is insufficient reliable information about the clinical effects of flaxseed for this purpose.
• Benign prostatic hyperplasia (BPH). It is unclear if oral flaxseed lignan improves symptoms of BPH. Details: A small clinical study in patients with BPH shows that taking a specific flaxseed lignan extract (BeneFlax, Archer Daniels Midland Co.) 300 mg or 600 mg daily for 4 months improves lower urinary tract symptom scores when compared with placebo. Additionally, the 600 mg dose was associated with improved quality of life when compared with placebo (21193).
• Breast cancer. It is unclear if oral flaxseed reduces the risk for breast cancer or the progression of breast cancer. Details: A small clinical study in females newly diagnosed with breast cancer shows that consuming a muffin containing ground flaxseed 25 grams daily for about 40 days reduces markers of tumor cell proliferation when compared with baseline, but not when compared with placebo (16765). The effect of flaxseed intake on breast cancer outcomes was not assessed. Dietary lignans, which occur in flaxseed, have been linked with a lower risk of developing breast cancer. Most large-scale population studies have found that high intake of dietary lignans and serum levels of the lignan enterolactone are associated with a reduced risk of developing breast cancer (16775,16776,16777,16779,16781,16782,16783,16785). It is unclear if flaxseed lignan, specifically, is beneficial for reducing the risk of breast cancer.
• Burning mouth syndrome. Flaxseed has only been evaluated in a mouthwash in combination with German chamomile; its effect when used alone is unclear. Details: A small clinical study in female patients with burning mouth syndrome shows that using a homemade mouthwash containing boiled whole flaxseed 10 grams and German chamomile 1 gram in 200 mL of water 3-4 times daily for 3 months decreases subjective burning and dry mouth symptoms, increases salivary flow rate, and decreases saliva viscosity when compared with baseline (104807). However, the validity of these results is limited by the lack of a control group and product standardization, as the mouthwash was prepared by each patient from ingredients they purchased.
• Cardiovascular disease (CVD). It is unclear if oral flaxseed or flaxseed lignans reduce the development or progression of CVD. Details: A small clinical study in older adults that were also given dietary advice shows that taking flaxseed 30 grams daily for 12 weeks, starting 4 weeks after percutaneous coronary intervention (PCI), more than doubles flow mediated dilation when compared with a group not taking flaxseed (101945). However, population research has found that total dietary intake of lignans, including flaxseed lignans, is not associated with a reduced risk of coronary heart disease or all-cause mortality (16787). This research did not specifically assess the effect of flaxseed intake on CVD.
• Chronic kidney disease (CKD). Although there is interest in using oral flaxseed for CKD, there is insufficient reliable information about the clinical effects of flaxseed for this condition.
• Colorectal cancer. It is unclear if oral flaxseed reduces the risk of colorectal cancer. Details: Flaxseed is one source of dietary lignans. Population research has found that serum levels of lignans are not associated with risk of developing colorectal cancer (16778). However, other population research has found that high dietary intake of lignans is associated with a reduced risk of colorectal cancer (16784), and that higher serum levels of dietary lignans are associated with a reduced risk of colorectal adenomas (16788). It is unclear if flaxseed lignan, specifically, is beneficial for reducing the risk of colorectal cancer.
• Endometrial cancer. It is unclear if oral flaxseed reduces the risk of endometrial cancer. Details: Flaxseed is one source of dietary lignans. A large-scale population study has found that serum levels of lignans are not associated with risk of developing endometrial cancer (16786).This research did not specifically assess the effect of flaxseed intake on endometrial cancer risk.
• Fatigue. It is unclear if oral ground flaxseed reduces fatigue in overweight children. Details: A small non-blinded clinical study in overweight healthy children ages 7-18 shows that consuming ground flaxseed 20 grams in divided doses with food daily for 4 weeks seems to modestly reduce mental fatigue but not physical fatigue when compared with puffed wheat 25 grams daily (105473).
• Impaired glucose tolerance (prediabetes). It is unclear if oral flaxseed is beneficial in prediabetes. Details: A small clinical study in adults with prediabetes shows that consuming milled flaxseed 20 grams or 40 grams daily for 12 weeks does not improve glycemic control, but modestly reduces systolic blood pressure, when compared with no intervention (96434).
• Irritable bowel syndrome (IBS). It is unclear if oral flaxseed improves IBS symptoms. Details: A small open-label clinical study in patients with IBS suggests that consuming whole or ground flaxseed 24 grams daily for 4 weeks does not improve quality of life, severity of IBS symptoms, or number of bowel movements when compared with no intervention (21198).
• Lung cancer. It is unclear if oral flaxseed reduces the risk of lung cancer. Details: Observational research has found that consuming a higher amount of dietary phytoestrogens, such as the lignan metabolites and precursors found in flaxseed, is associated with a lower risk of developing lung cancer when compared to those who consume smaller amounts (13190). It is unclear if flaxseed, specifically, is beneficial for reducing the risk of lung cancer.
• Menopausal symptoms. There is contradictory evidence about the effects of flaxseed for reducing menopausal symptoms. Details: Some preliminary clinical research in postmenopausal adults shows that taking either flaxseed meal 90 grams daily or a specific flaxseed extract (Biogalenica, Medicinal Compounding Pharmacy) 1000 mg daily for 6 months reduces menopausal symptoms and the frequency of hot flashes when compared to baseline (21200). Other small clinical studies in postmenopausal adults show that consuming ground flaxseed orally 40 grams daily reduces symptoms of hot flashes by about 35% and night sweats by about 44% when compared to baseline (10978,12910). However, similar reductions have been observed with placebos, such as wheat germ (12910,18224). Higher quality studies of flaxseed used in food products have yielded negative results. One clinical trial in postmenopausal adults shows that taking a specific flaxseed-containing bar (Glambia Nutritionals) providing 7 grams of flaxseed and 410 mg of lignans reduces hot flash frequency by 28% and hot flash scores by 50% when compared to baseline, but not when compared with placebo (18224). In another small clinical study, consuming muffins containing flaxseed 25 grams daily providing 50 mg lignans did not improve hot flashes or measures of quality of life when compared with placebo in a similar patient population (16762). Eating flaxseed-enriched bread providing 25 grams of flaxseed daily for 12 weeks also did not improve menopausal symptoms or reduce the frequency of hot flashes when compared to control (22176).
• Metabolic syndrome. Small studies suggest that oral flaxseed is beneficial for metabolic syndrome. Details: One small clinical study in older adults shows that taking a specific flaxseed lignan extract (BeneFlax, Archer Daniels Midland Co.) 550 mg three times daily for 6 months reduces metabolic syndrome risk scores when compared with placebo in males, but not females (21197). Another small open-label clinical trial in patients with metabolic syndrome suggests that taking flaxseed powder 30 grams daily for 12 weeks modestly reduces the number of people meeting the criteria for metabolic syndrome when compared with no supplementation (105276). However, food containing flaxseed does not seem to be as beneficial. Some clinical research in Asian Americans with metabolic syndrome shows that eating bread containing flaxseed 30 grams daily plus lifestyle counseling for 12 weeks does not improve markers of metabolic syndrome when compared with lifestyle counseling alone (21199).
• Nonalcoholic fatty liver disease (NAFLD). Small clinical studies suggest that oral flaxseed may modestly reduce markers of liver disease progression in patients with NAFLD. Details: A small clinical pilot study in adults with NAFLD shows that taking brown milled flaxseed 30 grams daily for 12 weeks along with lifestyle modification reduces fibrosis by 21% and steatosis by about 15.3%, compared with reductions of 9.7% and 5.5%, respectively, in those following lifestyle modifications alone (96249). A larger follow-up clinical study in patients with NAFLD shows that taking brown milled flaxseed 30 grams daily for 12 weeks in addition to lifestyle modification reduces steatosis by about 28%, compared with a 16% reduction in the lifestyle modification group (105275).
• Osteoarthritis. It is unclear if topical flaxseed is beneficial in patients with osteoarthritis. Details: A small clinical study in patients with hand osteoarthritis who are using routine treatments shows that using a flaxseed poultice compress once daily for 7 days improves pain by 63% and hand function by 66% when compared with a hot compress or no compress in combination with routine treatments. Some of the benefit was maintained for at least a week following treatment (101946).
• Peripheral arterial disease (PAD). It is unclear if oral flaxseed is beneficial in patients with PAD. Details: Clinical research in patients with PAD shows that taking milled flaxseed 30 grams daily mixed with a variety of foods for one year does not reduce the incidence of cardiac arrhythmias or improve the distance walked until claudication when compared with placebo (101942). This study may have been inadequately powered to detect differences between groups.
• Pharyngitis. Although there is interest in using oral flaxseed for pharyngitis, there is insufficient reliable information about the clinical effects of flaxseed for this purpose.
• Polycystic ovary syndrome (PCOS). It is unclear if oral flaxseed is beneficial in patients with PCOS. Details: A small open-label clinical study in patients with PCOS shows that taking flaxseed 30 grams daily for 12 weeks in conjunction with receiving lifestyle modification advice reduces triglyceride and insulin levels and improves insulin resistance when compared with lifestyle modification advice alone. About 69% of those in the treatment group who had irregular menstrual cycles at baseline had a regular cycle at the end of treatment, compared with no significant improvement in the control group. Flaxseed did not affect body weight, low-density lipoprotein (LDL) cholesterol, or blood glucose when compared with control (101943).
• Prostate cancer. Small clinical studies suggest that oral flaxseed may modestly improve biomarkers of prostate cancer. Details: A very small clinical trial in patients with prostatic intraepithelial neoplasia (PIN), a precancerous proliferation of prostatic epithelial cells, shows that adding ground flaxseed (Alena, Enreco) 30 grams daily to a fat-restricted diet for 6 months lowers prostate specific antigen (PSA) levels and slows prostate epithelium proliferation when compared with baseline (12908). This finding is limited by the lack of a placebo group. A clinical study in patients with prostate cancer awaiting prostatectomy shows that taking ground flaxseed (Alena, Enreco) 30 grams daily with or without a fat-restricted diet for about 30 days reduces tissue proliferation rate, but does not reduce PSA, when compared with control (16761).
• Radiation-induced pneumonitis. It is unclear if oral flaxseed is beneficial for preventing radiation-induced pneumonitis in patients with non-small cell lung cancer (NSCLC). Details: A very small, clinical trial in adults with locally advanced or metastatic NSCLC currently undergoing chemoradiation therapy shows that taking ground flaxseed (Golden Valley Flax; Hylden Farms) 40 grams daily, starting one week prior to radiotherapy and continuing until completion of treatment, may reduce the risk of radiation-induced pneumonitis when compared with baseline, with only 1 patient (5%) developing a grade ≥3 event and no cases of grade 2 events (108042). The validity of these findings is limited by the lack of a comparator group and a low adherence rate due to tolerability issues.
• Rheumatoid arthritis (RA). It is unclear if oral flaxseed is beneficial in patents with RA. Details: A clinical study in adults with RA shows that following either a regular or anti-inflammatory diet supplemented with oral flaxseed 30 grams daily for 12 weeks improves disease activity score 28-joint (DAS28-ESR), as well as pain and quality of life outcomes, such as emotional well-being and vitality, when compared with baseline (108048). The validity of these findings is limited by the lack of a comparator group.
• Ulcerative colitis. It is unclear if oral flaxseed is beneficial in patients with ulcerative colitis. Details: A small open-label clinical study in patients with ulcerative colitis shows that taking ground flaxseed 30 grams daily for 12 weeks seems to modestly reduce inflammatory markers and disease severity and improve quality of life when compared with control (101941). A nonblinded, clinical study in adults with mild to moderate ulcerative colitis shows that taking brown milled flaxseed 15 grams twice daily for 12 weeks improves disease severity scores when compared with placebo (108045). The validity of these findings is limited by the lack of blinding and short duration of treatment. More evidence is needed to rate flaxseed for these uses.

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POSSIBLY INEFFECTIVE

• Bipolar disorder. Oral flaxseed oil does not seem to reduce symptoms of bipolar disorder in children. Details: Clinical research in children ages 6-17 years with bipolar disorder shows that taking flaxseed oil, titrated to provide up to 6.5 grams of the flaxseed oil constituent alpha-linolenic acid, daily for 16 weeks does not improve symptoms of mania or depression when compared with placebo (66044).
• Hyperlipidemia. Oral flaxseed oil does not seem to reduce cholesterol levels. Details: Although some evidence from preliminary, low-quality clinical studies disagrees (21698,26466,76696), most clinical research shows that taking flaxseed oil does not reduce cholesterol or triglyceride levels in patients with or without hypercholesterolemia or hypertriglyceridemia (2317,16791,16794,21693,21694,21696,21697,22177,72228,101947)(101954,101956,111062). A meta-analysis of clinical studies evaluating various flaxseed formulations suggests that flaxseed oil consumption may reduce apolipoprotein A levels, but not apolipoprotein B levels, when compared with control groups (108046). A subgroup analysis from another meta-analysis suggests that flaxseed oil may modestly improve levels of high-density lipoprotein cholesterol (108044). It should be noted that most research suggests that flaxseed, the source of flaxseed oil, can improve lipid levels in adults with hyperlipidemia. This difference may be due to lipid lowering components such as lignans, phytic acid, and polyphenols, that are found in flaxseed, but not flaxseed oil. See the Flaxseed monograph for more information.
• Obesity. Oral flaxseed oil does not seem to improve weight loss. Details: A meta-analysis of clinical research in overweight adults shows that flaxseed oil consumption does not reduce body weight, body mass index, or waist circumference when compared with control (96427). This is in contrast to research suggesting that flaxseed, the source of flaxseed oil, can improve weight loss in obese and overweight adults. See the Flaxseed monograph for more information.
• Rheumatoid arthritis (RA). Oral flaxseed oil does not seem to improve symptoms of RA. Details: A small clinical study in patients with RA shows that taking flaxseed oil daily for 3 months does not seem to improve symptoms of pain and stiffness, and has no effect on laboratory measures of RA, such as C-reactive protein and erythrocyte sedimentation rate (ESR), when compared with control (5898).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Atherosclerosis. Small clinical trials show that taking flaxseed oil has modest benefit on metabolic risk factors in patients with plaque in the coronary artery. Details: Observational research in White adults has found that high dietary intake of linolenic acid, a flaxseed oil constituent, is associated with reduced calcified atherosclerotic plaque in the coronary arteries (12990). However, clinical research has not confirmed this finding. A small clinical trial in patients with coronary artery disease shows that taking flaxseed oil 5 grams in milk containing 1.5% fat reduces triglyceride levels by 14% when compared with the milk alone. However, there was no effect on systolic blood pressure, high-density lipoprotein (HDL) cholesterol, or low-density lipoprotein (LDL) cholesterol (101954). Additionally, another small study in a similar patient population shows that taking flaxseed oil 2 grams daily for 12 weeks has no effect on lipid levels when compared with placebo (101956).
• Attention deficit-hyperactivity disorder (ADHD). Oral flaxseed oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial in children with ADHD shows that taking flaxseed oil, providing 200 mg of alpha-linolenic acid, in combination with vitamin C 25 mg, twice daily can improve measures of attention, impulsivity, restlessness, and self-control when compared to baseline (14443). This finding is limited by the lack of a control group. Furthermore, it is unclear if the benefit is due to flaxseed oil, vitamin C, or the combination.
• Breast cancer. It is unclear if oral flaxseed oil reduces the risk of breast cancer. Details: Population research has found that females with higher levels of the flaxseed oil constituent, alpha-linolenic acid (ALA), in breast adipose tissue have a lower risk of breast cancer. Fatty acid composition of adipose tissue is thought to reflect past dietary intake, so researchers think high intake of ALA might have a cancer protective effect (7168,21689). Flaxseed oil is one source of ALA; it is unclear what effect, if any, flaxseed oil has on breast cancer risk.
• Burns. It is unclear if oral flaxseed oil improves wound healing and health in people with burns. Details: A small clinical trial in patients with mild to moderate burns shows that eating cookies containing flaxseed oil 30 grams and isolated soy protein (ISP) 50 grams daily for 3 weeks improves the rate of wound healing when compared with control cookies. It seems to take at least 3 weeks before this difference is observed. However, there is no significant difference in the rate of wound healing when compared with cookies containing ISP with corn oil (99401). It is possible that the study was underpowered to detect a difference between these two groups.
• Cardiovascular disease (CVD). It is unclear if oral flaxseed oil reduces the risk of CVD. Details: Flaxseed oil is a source of alpha-linolenic acid (ALA). A meta-analysis of observational studies has found that, overall, increasing dietary intake of ALA by 1.2 grams daily is associated with a 20% reduced risk of fatal coronary heart disease in people with existing heart disease (12978). Some research suggests that ALA has a greater impact on coronary heart disease when intake of fish oils is low (12989). It is unknown if flaxseed oil supplements have these same effects. Additionally, it is difficult to separate effects of dietary ALA in these studies from those of other dietary, lifestyle, or drug interventions (12917).
• Carpal tunnel syndrome. It is unclear if topical flaxseed oil reduces carpal tunnel pain. Details: Preliminary clinical research in patients with carpal tunnel syndrome who wear a wrist splint at night shows that applying flaxseed oil 5 drops topically on the palmar wrist twice daily for 4 weeks improves subjective symptom scores by 30%, function scores by 17%, and sensory nerve conduction velocity of the median nerve by about 7% when compared to baseline. Compared to the changes observed for patients in the placebo group, these improvements were significant (25691). It is unclear if this benefit persists long-term or how topical flaxseed oil compares to other standard treatments for carpal tunnel syndrome.
• Chronic kidney disease (CKD). Although there is interest in using oral flaxseed oil for CKD, there is insufficient reliable information about the clinical effects of flaxseed for this condition.
• Cognitive function. It is unclear if oral flaxseed oil improves cognitive function in healthy adults. Details: Clinical research in healthy older Japanese adults with normal cognitive function shows that taking flaxseed oil 3.7 grams daily for 12 weeks modestly improves verbal fluency when compared with taking placebo. However, there was no effect on other measures of cognitive function, including attention, concentration, and memory (111060).
• Diabetes. Oral flaxseed oil may not improve glycemic control in patients with type 2 diabetes. However, there may be some benefit in patients with gestational diabetes. Details: Most clinical research in patients with type 2 diabetes shows that taking flaxseed oil, providing about 1-16 grams of alpha-linolenic acid, daily for up to 6 months does not improve fasting blood glucose, glycated hemoglobin (HbA1C), or insulin resistance when compared with placebo (16792,66065,96428,96431,101956,111062). While taking flaxseed oil does not seem to be beneficial for type 2 diabetes, it might improve outcomes in gestational diabetes. A small clinical study in pregnant patients (24-28 weeks gestation) with gestational diabetes shows that taking flaxseed oil 1 gram twice daily for 6 weeks reduces fasting levels of glucose and insulin and improves insulin resistance when compared with placebo (101957). Another small clinical study in patients with gestational diabetes shows that taking flaxseed oil 1 gram, containing 400 mg of alpha-linolenic acid, along with vitamin E 400 IU daily for 6 weeks reduces blood glucose levels, insulin levels, and insulin resistance and improves beta-cell function when compared with placebo (96432). It is unclear if the findings from this latter study are due to flaxseed oil, vitamin E, or the combination.
• Diabetic foot ulcers. It is unclear if oral flaxseed oil improves the healing of diabetic foot ulcers. Details: One small clinical trial in adults with grade 3 diabetic foot ulcers shows that taking flaxseed oil 1 gram twice daily for 12 weeks in conjunction with intravenous antibiotics for the first 3 weeks reduces ulcer size when compared with placebo (96431).
• Dry eye. Flaxseed oil, both orally and as an eye drop, has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small clinical study in patients with dry eye shows that taking a specific combination product (TheraTears Nutrition, Advanced Vision Research) containing eicosapentaenoic acid 450 mg, docosahexaenoic acid 300 mg, and flaxseed oil 1000 mg daily for 90 days reduces subjective symptoms of dry eye and might increase tear production when compared with placebo. However, it did not improve meibomian gland secretions or tear evaporation rate when compared with placebo (17523). Eye drops with flaxseed oil have also been tried for dry eye. A clinical study shows that using a specific product (Refresh Optive MEGA-3 Preservative-Free Lubricant Eye Drops, Allergan plc) which contains flaxseed oil and trehalose in addition to other ingredients such as carboxymethylcellulose (CMC) and castor oil twice daily for 90 days improves dry eye symptoms when compared to baseline, but not when compared with the same eye drops formulated without flaxseed oil and trehalose (101953).
• Dry skin. There is conflicting evidence regarding the use of flaxseed oil for dry skin. Details: Some clinical research suggests that taking flaxseed oil 2.2 grams orally in combination with alpha-tocopherol 10 mg daily for 12 weeks does not improve skin hydration when compared with placebo or borage oil in females with dry skin, although the combination seems to improve the sensitivity of dry skin (21908). Other clinical research suggests that taking flaxseed oil 2.2 grams daily for 12 weeks improves skin hydration and roughness when compared with safflower oil (21909).
• Endometrial hyperplasia. It is unclear if oral flaxseed oil reduces endometrial hyperplasia. Details: A small clinical trial in adults with endometrial hyperplasia shows that taking flaxseed oil 1 gram twice daily for 12 weeks does not induce endometrial regression or reduce cholesterol levels when compared with placebo. However, there appears to be a small benefit on fasting plasma glucose and insulin levels (101955).
• Hypertension. Small studies suggest that flaxseed oil may modestly lower blood pressure in some patients. Details: Epidemiological research has found that high dietary intake of linolenic acid, a flaxseed oil constituent, is associated with a reduced risk of developing hypertension (12991). Meta-analyses of small clinical studies in patients with and without hypertension show that receiving flaxseed oil 1.2-30 grams daily for 4-24 weeks reduces systolic and diastolic blood pressure by 0.5 mmHg to 4 mmHg, when compared with control (96426,111063). One meta-analysis limited to small clinical trials in patients with metabolic syndrome, hypercholesterolemia, or hypertension, shows that taking flaxseed oil 25 mL or 2.2 to 9.2 grams daily for 7-12 weeks reduces systolic blood pressure by about 3.9 mmHg; however, there is no effect on diastolic blood pressure (111067). The small size and heterogeneity of the studies included in these meta-analysis limit the validity of these findings. Also, the effect of taking flaxseed oil in patients specifically with hypertension is unclear from this available research. Flaxseed oil has also been evaluated in combination with other oils and dietary interventions, with mixed evidence of benefit. Flaxseed oil 19 grams, providing 10.5 grams of alpha-linolenic acid, seems to reduce blood pressure when combined with walnuts and walnut oil daily for 6 weeks (21905). However, consuming 60 grams of a combination of flaxseed and safflower oils in a 6:4 ratio daily for 4 weeks does not seem to affect blood pressure when compared with baseline (26466).
• Mastalgia. It is unclear if oral flaxseed oil is beneficial in patients with mastalgia. Details: A clinical study in adults with fibrocystic breasts and mastalgia shows that taking flaxseed oil 1000 mg containing 350 mg alpha-linolenic acid twice daily for 2 months reduces pain when compared with baseline, but is no different than taking vitamin E 200 IU daily (105477).
• Metabolic syndrome. It is unclear if oral flaxseed oil is beneficial in patients with metabolic syndrome. Details: A small clinical study in patients with metabolic syndrome shows that taking flaxseed oil 20 mL daily for 7 weeks does not improve coagulation scores based on prothrombin time, partial thromboplastin time, and the international normalized ratio (INR) when compared with sunflower oil (101951).
• Nonalcoholic fatty liver disease (NAFLD). It is unclear if oral flaxseed oil is beneficial in patients with NAFLD. Details: Clinical research in overweight or obese patients with NAFLD shows that taking flaxseed oil 20 grams daily for 12 weeks as part of a hypocaloric diet improves the grade of fatty liver by 41%, compared with 18% in patients taking sunflower oil. There was also a small effect on body mass index, although there was no effect on liver enzymes, glycemic control, or body composition (101952).
• Parkinson disease. Oral flaxseed oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small clinical study in patients with Parkinson disease shows that taking flaxseed oil 1 gram daily plus vitamin E 400 IU daily for 12 weeks improves the Unified Parkinson Disease Rating Scale (UPDRS) total score by 3.3 points, compared to a 4.4-point worsening in the placebo group (96430). However, it is unclear if this change is clinically meaningful. The minimal clinically important improvement in UPDRS total score is 4.3 points, while a moderate improvement ranges from 9 to 17 points (95686). Also, it is not clear if these findings are due to flaxseed oil, vitamin E, or the combination.
• Physical performance. It is unclear if oral flaxseed oil improves physical performance in older adults. Details: A small clinical study in elderly adults without previous exercise training suggests that flaxseed oil containing alpha-linolenic acid does not improve muscle strength when compared with placebo (65937).
• Pneumonia. It is unclear if oral flaxseed oil helps to prevent pneumonia. Details: Epidemiological research has found that increasing dietary alpha-linolenic acid, which occurs in flaxseed oil, is associated with a reduced risk of community-acquired pneumonia (13760). However, this research did not specifically assess the effect of flaxseed oil intake on pneumonia.
• Polycystic ovary syndrome (PCOS). Small clinical studies suggest that oral flaxseed oil might help to improve some markers of PCOS. Details: A small clinical study in patients with PCOS shows that taking flaxseed oil, providing 545 mg of alpha-linolenic acid, for 6 weeks lowers triglycerides but does not affect weight, hormone levels, glycemic control, or cholesterol levels when compared to baseline (21906). This finding is limited by the lack of a control group. Another small clinical study in patients with PCOS shows that taking flaxseed oil, providing 1 gram of omega-3 fatty acids, twice daily in addition to metformin for 12 weeks decreases triglyceride and insulin levels, but does not affect fasting blood glucose, testosterone levels, free androgen index, or total cholesterol when compared with placebo (99402).
• Prostate cancer. Oral flaxseed oil does not seem to be linked to prostate cancer risk. Details: Although some epidemiologic research has found that high dietary intake of alpha-linolenic acid, a constituent of flaxseed oil, is associated with an increased risk for prostate cancer (1334,1337,2558,7823,7147,12978,12961), other research has found no association (12961,15736). Furthermore, it appears that alpha-linolenic acid from plant sources, such as flaxseed or flaxseed oil, does not increase prostate cancer risk (12909).
• Ulcerative colitis. It is unclear if oral flaxseed oil is beneficial in patients with ulcerative colitis. Details: A small open-label clinical study in patients with ulcerative colitis shows that taking flaxseed oil 10 grams daily for 12 weeks seems to modestly reduce inflammatory markers and disease severity and improve quality of life when compared with control (101941). More evidence is needed to rate flaxseed oil for these uses.

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LIKELY SAFE ...when docosahexaenoic acid (DHA)-enriched algal oil is used orally and appropriately. Specific algal oils (DHASCO and DHASCO-S, Martek Biosciences Corp) have been safely used in clinical research at doses of 1.5-15 grams daily for 4-15 weeks (48254). One of these oils (DHASCO, Martek Biosciences Corp) has also been safely used in doses of about 1.5-9 grams, providing DHA 30 mg/kg, daily for up to 4 years (90684). These algal oils provide approximately 35% to 40% DHA, small amounts of saturated and monounsaturated fatty acids, and insignificant amounts of eicosapentaenoic acid (EPA) (48254). However, there is some concern that high intake of omega-3 fatty acids in algal oil might increase the risk of bleeding. For this reason, the US Food and Drug Administration (FDA) recommends that consumers limit intake of DHA plus EPA to 3 grams daily, with no more than 2 grams daily from a dietary supplement (95739).

POSSIBLY SAFE ...when eicosapentaenoic acid (EPA)-enriched algal oil is used orally and appropriately. A specific algal oil supplement (Almega PL) providing EPA 250 mg daily has been used with apparent safety for up to 12 weeks (103314). However, there is some concern that high intake of omega-3 fatty acids in algal oil might increase the risk of bleeding. For this reason, the US Food and Drug Administration (FDA) recommends that consumers limit intake of DHA plus EPA to 3 grams daily, with no more than 2 grams daily from a dietary supplement (95739).

POSSIBLY UNSAFE ...when used orally in high doses. Algal oil contains docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA). There is some concern that taking more than 3 grams of EPA plus DHA daily might decrease platelet aggregation and increase the risk of bleeding (1313). The US Food and Drug Administration (FDA) recommends that consumers limit intake of DHA plus EPA to 3 grams daily, with no more than 2 grams daily from a dietary supplement (95739).

CHILDREN: LIKELY SAFE
when used orally and appropriately. Docosahexaenoic acid (DHA)-enriched algal oil has been safely used as a source of DHA in some infant formulas since 2002 (5941,48084,48095,48343,98548). One specific type of algal oil (DHASCO) is generally recognized as safe (GRAS) for use in infant formula when combined with a fungal-derived arachidonic acid oil (ARASCO) (48176). In children 7 years and older, this same algal oil (DHASCO) providing DHA 30 mg/kg daily has been used safely for up to 4 years (90684). Algal oil 1-2.4 grams providing 0.4-1 grams of DHA daily has also been safely used in children ages 4 years and older for up to 1 year (11333,90665,104560). There is insufficient reliable information available about the safety of eicosapentaenoic acid (EPA)-enriched algal oils in children.

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately. Docosahexaenoic acid (DHA)-enriched algal oil is commonly included as a component of prenatal vitamins. Algal oil providing DHA 400-600 mg daily during pregnancy has been used with apparent safety in most clinical research (90672,90694). When taken as a prenatal supplement, DHA-enriched algal oil increases DHA levels in breast milk (90685). Taking DHA-enriched algal oil during lactation also increases levels of DHA in breast milk (109214,110362). One study found that using DHA-enriched algal oil during lactation increased the risk of bronchopulmonary dysplasia in breastfed infants born at less than 29 weeks gestational age; however, it is unclear if this was due to DHA or various confounding factors (104559). The tolerable upper intake level of DHA during pregnancy or lactation has not been established. Most experts recommend an intake of DHA 200-300 mg daily during pregnancy and lactation. While it is typically advised that this need be met by consuming 8-12 ounces of seafood weekly during pregnancy and 4-8 ounces weekly during lactation, individuals with nutrient deficiency or those following a vegan diet may meet this need with supplementation, including algal oil (95740,95741). There is insufficient reliable information available about the safety of eicosapentaenoic acid (EPA)-enriched algal oils during pregnancy or lactation.

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LIKELY SAFE ...when ground flaxseed is used orally and appropriately. Ground flaxseed has been safely used in numerous clinical trials in doses up to 30-60 grams daily for up to 1 year (6803,6808,8020,10952,10978,12908,12910) (16760,16761,16762,16765,16766,18224,21191,21194,21196,21198) (21199,21200,22176,22179,22180,22181,65866,66065) (101943,101949,101950).

POSSIBLY SAFE ...when flaxseed lignan extract or mucilage is used orally and appropriately. Some clinical research shows that a specific flaxseed lignan extract (Flax Essence, Jarrow Formulas) 600 mg daily can be used with apparent safety for up to 12 weeks (16768). Additional clinical research shows that other flaxseed lignin extracts can be used with apparent safety for up to 6 months (21193,21197,21200). In one clinical trial, flaxseed mucilage was used with apparent safety at a dose of up to 5120 mg daily for up to 12 weeks (108047)....when flaxseed is used topically in a warm poultice (101946).

POSSIBLY UNSAFE ...when raw or unripe flaxseed is used orally. Raw flaxseed contains potentially toxic cyanogenic glycosides (linustatin, neolinustatin, and linamarin); however, these glycosides have not been detected after flaxseed is baked (5899). Unripe flaxseeds are also thought to be poisonous when consumed due to cyanide content.

PREGNANCY: POSSIBLY UNSAFE
when used orally. Flaxseed can have mild estrogenic effects. Theoretically, this might adversely affect pregnancy (9592,12907); however, there is no reliable clinical evidence about the effects of flaxseed on pregnancy outcomes.

LACTATION:
Insufficient reliable information available; avoid using.

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LIKELY SAFE ...when used orally and appropriately for medicinal purposes, short-term. Flaxseed oil has been used safely in doses up to 2 grams daily for up to 6 months. Higher doses of up to 24 grams daily has been safely used for up to 7 weeks (845,3912,5898,14443,16789,16791,16794,16795,17523,101951,101952,101955).

POSSIBLY SAFE ...when used topically for medicinal purposes, short-term. Flaxseed oil has been used safely on the wrist for up to 4 weeks (25691). ...when used in eye drops twice daily for up to 90 days (101953).

CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term. Some evidence suggests that flaxseed oil, providing 200 mg of alpha-linolenic acid, can be safely used in children for up to 3 months (14443).

PREGNANCY: POSSIBLY SAFE
when used orally and appropriately for medicinal purposes, short-term. Although flaxseed oil has been used with apparent safety in clinical research in doses of 1-2 grams daily for up to 6 weeks (96432,101957), some population research has found that consuming flaxseed oil during the second and third trimesters of pregnancy is associated with a four-fold increased risk of premature birth (16797).

LACTATION:
Insufficient reliable information available; avoid using.

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, algal oil may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.  Details The risk of interaction is highest for algal oil containing high amounts (> 2 grams daily) of eicosapentaenoic acid (EPA), or EPA and docosahexaenoic acid (DHA). High doses of EPA or oils containing EPA and DHA can reduce platelet aggregation in humans (8671,8679,8696,9930,13769,21223,21224,66258). However, most algal oil contains very little EPA and larger amounts of DHA. While some conflicting evidence exist, most research shows that DHA alone does not affect blood clotting (9930,11112,11113,48020).

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking algal oil with antidiabetes drugs might interfere with the effects of antidiabetes drugs and reduce their effects.  Details Most algal oil contains docosahexaenoic acid (DHA). Clinical research in people with type 2 diabetes, including those taking antidiabetes drugs, shows that taking DHA 4 grams daily for 6 weeks increases fasting blood glucose levels by about 18 mg/dL when compared with taking olive oil (10321).

ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking algal oil with antihypertensive drugs might increase the risk of hypotension.  Details Algal oil usually contains docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA). There is evidence that fish oil, which also contains DHA and EPA, can modestly lower blood pressure and might have additive effects in patients treated with antihypertensive drugs (1001,1020,1030,1033,47944,48013,48020,48163).

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ANTIBIOTIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, antibiotics might interfere with the metabolism of flaxseed constituents, which could potentially alter the effects of flaxseed.  Details Some potential benefits of flaxseed are thought to be due to its lignan content. Secoisolariciresinol diglucoside (SDG), a major lignan precursor, is found in high concentrations in flaxseed. SDG is converted by bacteria in the colon to the lignans enterolactone and enterodiol (5897,8022,8023,9592). Antibiotics alter the flora of the colon, which could theoretically alter the metabolism of flaxseed.

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Theoretically, using flaxseed in combination with anticoagulant or antiplatelet drugs might have additive effects and increase the risk of bleeding.  Details Some clinical evidence suggests that the oil contained in flaxseed can decrease platelet aggregation (5898,21912).

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Theoretically, flaxseed might have additive effects when used with antidiabetes drugs and increase the risk for hypoglycemia.  Details Some clinical research suggests that flaxseed can lower blood glucose levels (5899,10978,21194,21196,111061).

ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, flaxseed might have additive effects when used with antihypertensive drugs and increase the risk of hypotension.  Details Clinical research shows that daily flaxseed consumption, especially for longer than 12 weeks, modestly reduces blood pressure (21197,26487,96426,96428,111063).

ESTROGENS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking flaxseed might decrease the effects of estrogens.  Details Flaxseed contains lignans with mild estrogenic and possible antiestrogenic effects. The lignans seem to compete with circulating endogenous estrogen and might reduce estrogen binding to estrogen receptors, resulting in an anti-estrogen effect (8868,9593). It is unclear if this effect transfers to exogenously administered estrogens.

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, using flaxseed oil in combination with anticoagulant or antiplatelet drugs might have additive effects and increase the risk of bleeding.  Details Small clinical studies show that consuming flaxseed oil might decrease platelet aggregation and increase bleeding time (5898,21912).

ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, combining flaxseed oil with other antihypertensive drugs might have additive effects and increase the risk of hypotension.  Details Some clinical evidence suggests that long-term consumption of flaxseed oil can modestly lower systolic and diastolic blood pressure, while other clinical research shows no effect (16793,96426,101941,101954,111063,111067).

EZETIMIBE (Zetia) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Concomitant use of flaxseed oil and ezetimibe reduces the absorption of alpha-linolenic acid from flaxseed oil.  Details In one clinical study, concomitant consumption of ezetimibe 10 mg daily with flaxseed oil 2 grams providing 1 gram of alpha-linolenic acid daily blocked the absorption of alpha-linolenic acid, resulting in an overall reduction in alpha-linolenic plasma levels from baseline (96433).

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General ...Orally, algal oil is generally well tolerated.
Most Common Adverse Effects:
Orally: Fishy burps and gastrointestinal symptoms.

Cardiovascular ...Orally, docosahexaenoic acid (DHA)-enriched algal oil 68 grams daily) can modestly increase low-density lipoprotein (LDL) cholesterol levels by about 8% in patients without coronary heart disease. This increase in LDL cholesterol is similar to that observed for patients taking purified DHA 4 grams daily (90669).

Dermatologic ...Orally, one parent of a pediatric patient treated with algal oil providing docosahexaenoic acid (DHA) 600 mg daily for 16 weeks reported increased hair loss beginning 6 weeks after completion of supplementation (90699). It is unclear if this adverse effect is specifically related to algal oil intake. Algal oil may theoretically cause itching, rash, or warmth in the hands due to its constituents DHA and/or eicosapentaenoic acid (EPA) (15497,48217); however, while these adverse effects have been reported with other sources of DHA and EPA, they have not been reported specifically for patients taking algal oil.

Gastrointestinal ...Orally, fishy burps and mild nonspecific gastrointestinal symptoms have been reported in clinical research for participants taking algal oil providing docosahexaenoic acid (DHA) 600 mg daily for 2 weeks (48220). Algal oil may theoretically cause other adverse events including nausea, vomiting, flatulence, and loose stools due to its DHA and eicosapentaenoic acid (EPA) constituents (1009,1313,8699,10007,10869,11333,15497,103314); however, these adverse effects have not been reported specifically for patients taking algal oil.

Genitourinary ...Orally, algal oil may theoretically cause decreased libido due to its constituent docosahexaenoic acid (DHA). In one clinical study, one patient taking DHA 1, 2, or 4 grams daily (specific dose unclear) reported decreased libido (48217); however, this adverse effect has not been reported specifically for patients taking algal oil.

Hematologic ...Orally, algal oil might cause nose bleeds, but this is uncommon. Onset of severe nose bleeds has been reported in one clinical study in one child who took algal oil providing docosahexaenoic acid (DHA) 600 mg daily (98542). Some algal oil may theoretically decrease blood coagulation and increase the risk of bleeding in some patients due to its fatty acid constituents (1009,1313,8699,10007,15497); however, the potential risk might depend on the ratio of DHA and eicosapentaenoic acid (EPA) in the algal oil. Most clinical research shows that DHA alone does not affect blood clotting (11112,11113,48020). Therefore, algal oils containing high amounts of DHA and negligible amounts of EPA seem unlikely to increase the risk. However, there is evidence that taking high doses of oils providing EPA and DHA might decrease blood coagulation and increase the risk of bleeding (1313). The US Food and Drug Administration (FDA) recommends that consumers limit intake of EPA plus DHA to 3 grams daily, with no more than 2 grams daily from a dietary supplement (95739). While these adverse effects have not been reported specifically for patients taking algal oil, patients should limit intake of algal oil to daily doses providing no more than 2 grams of EPA and DHA.

Musculoskeletal ...Orally, algal oil may theoretically cause joint pain due to its constituent, eicosapentaenoic acid (EPA), although results are conflicting. In one clinical study, a higher percentage of patients treated with EPA ethyl ester 2 or 4 grams daily experienced arthralgia compared to placebo (3.4% and 1.7% vs 0.4%, respectively) (91409). However, in another study, slightly fewer patients taking EPA ethyl ester 1.8 grams daily experienced joint, lumbar, or muscle pain compared to placebo (1.6% vs 2.0%, respectively) (15497). These adverse effects have not been reported specifically for patients taking algal oil.

Neurologic/CNS ...Orally, algal oil may theoretically cause insomnia or light-headedness/dizziness due to its constituent docosahexaenoic acid (DHA). In one clinical study, three adult patients reported light-headedness or dizziness, and one patient reported insomnia, when treated with DHA 2 grams daily. It is unclear if these events are treatment related, as one patient in the placebo group also reported insomnia (10869). These adverse effects have not been reported specifically for patients taking algal oil.

Oncologic ...Orally, algal oil may theoretically increase the risk of prostate cancer due to its constituent docosahexaenoic acid (DHA); however, further research is needed to clarify this finding. An analysis of data from observational studies found that higher DHA intake is associated with a non-linear increased risk of prostate cancer (90677). However, it is unclear if supplemental DHA intake is associated with an increased risk of prostate cancer, and this association has not been reported specifically for patients taking algal oil.

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General ...Orally, flaxseed is usually well-tolerated.
Most Common Adverse Effects:
Orally: Bloating, diarrhea, gastrointestinal complaints.
Serious Adverse Effects (Rare):
Orally: Severe allergic reactions such as and anaphylaxis.

Gastrointestinal ...Integrating flaxseed in the diet can cause digestive symptoms similar to other sources of dietary fiber including bloating, fullness, flatulence, abdominal pain, diarrhea, constipation, dyspepsia, and nausea (12910,16761,16765,21198,21200,22176,22179,65866,101943). Higher doses are likely to cause more gastrointestinal side effects. Flaxseed can significantly increase the number of bowel movements and the risk for diarrhea (6803,8021,16765). Doses greater than 45 grams per day may not be tolerated for this reason (6802). Metallic aftertaste and bowel habit deterioration have also been reported in a clinical trial (21198).
There is some concern that taking large amounts of flaxseed could result in bowel obstruction due to the bulk forming laxative effects of flaxseed. Bowel obstruction occurred in one patient in a clinical trial (65866). However, this is not likely to occur if flaxseed is consumed with an adequate amount of fluids.

Immunologic ...Occasionally, allergic and anaphylactic reactions have been reported after ingestion of flaxseed (16761). Handling and processing flaxseed products might increase the risk of developing a positive antigen test to flaxseed and hypersensitivity (6809,12911,26471,26482).

Oncologic ...Flaxseed contains alpha-linolenic acid (ALA). High dietary intake of ALA has been associated with increased risk for prostate cancer (1337,2558,7823,7147,12978). However, ALA from plant sources, such as flaxseed, does not seem to increase this risk (12909).

Other ...Orally, partially defatted flaxseed, which is flaxseed with less alpha-linolenic acid, might increase triglyceride levels (6808). Raw or unripe flaxseed contains potentially toxic cyanogenic glycosides (linustatin, neolinustatin, and linamarin). These chemicals can increase blood levels and urinary excretion of thiocyanate in humans. However, these glycosides have not been detected after flaxseed is baked (5899).

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General ...Orally, flaxseed oil is generally well tolerated. Topically, flaxseed oil seems to be well-tolerated.
Most Common Adverse Effects:
Topically: Itching, redness.
Serious Adverse Effects (Rare):
Orally: Severe allergic reactions such as anaphylaxis.

Endocrine ...Orally, flaxseed oil might cause gynecomastia. In a case report, a 70-year-old male developed gynecomastia after taking flaxseed oil daily for 3 months. Discontinuing flaxseed oil lead to resolution of gynecomastia (105478).

Gastrointestinal ...Orally, flaxseed oil may cause a change in bowel habits, dry mouth, and dyspepsia when taken at a dose of about 5 grams daily. However, these effects have been reported by only a small number of patients (approximately 3%) (16794). High doses of flaxseed oil (30 grams per day and higher) have been associated with loose stools and diarrhea (5898,11025).

Immunologic ...Severe allergic reactions such as anaphylaxis have been reported with flaxseed oil ingestion and also in workers processing flaxseed products (6809).

Ocular/Otic ...Topically, eye drops containing flaxseed oil may cause redness and itching (101953).

Oncologic ...Flaxseed oil has not been linked to increased prostate cancer risk. Although epidemiologic research has found that high dietary intake of alpha-linolenic acid (ALA) is associated with increased prostate cancer risk (1337,2558,7147,7823,12978), this risk does not seem to apply to ALA from plant sources, like flaxseed (12909).

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