Enhanced CLA [Discontinued] by Prolab Nutrition

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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POSSIBLY EFFECTIVE

• Hypercholesterolemia. Several small studies suggest that oral safflower oil, as a substitute for coconut oil, butter, or other animal fats in the diet, may reduce total and low-density lipoprotein (LDL) cholesterol levels in patients with or without hypercholesterolemia. Details: Three small clinical studies in patients with or without hypercholesterolemia show that substituting coconut oil, butter, or other animal fats in the diet with safflower oil (36% of total daily calories) for 4-6 weeks can lower levels of total and LDL cholesterol, but has no beneficial effects on high-density lipoprotein (HDL) cholesterol or triglycerides (25391,25393,72310).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Coronary heart disease (CHD). Safflower oil, which is high in oleic acid, may be beneficial for reducing the risk of CHD when used to replace other dietary oils. Details: Some safflower 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).
• Cystic fibrosis. It is unclear if oral safflower oil is beneficial in children with cystic fibrosis. Details: A very small clinical study in children with cystic fibrosis shows that taking safflower oil 1 gram/kg daily for one year does not affect sweat chloride concentrations or disease severity when compared with age-matched controls (72281).
• Diabetes. Small clinical studies of oral safflower oil for improving glycemic control in patients with diabetes have yielded mixed results. Details: One very small clinical trial in patients with type 2 diabetes shows that taking safflower oil 10 grams daily for 3 weeks increases fasting blood glucose by 11% when compared to baseline. Insulin levels, insulin sensitivity, and lipid levels were not affected (13146). However, another small clinical study in obese, postmenopausal patients with type 2 diabetes shows that taking safflower oil 2 grams four times daily for 16 weeks decreases HbA1c by 0.64% and increases high-density lipoprotein (HDL) cholesterol by about 5 mg/dL when compared with conjugated linoleic acid (CLA) 2 grams four times daily. Insulin sensitivity and fasting blood glucose levels do not appear to be affected (94039). These differing outcomes may be due to the small study sizes and varied patient populations.
• Diabetic nephropathy. Small clinical studies suggest that intravenous safflower yellow, a component of safflower flower, might improve symptoms and markers of diabetic nephropathy. Details: A meta-analysis of 14 small and low-quality clinical studies in adults with diabetic nephropathy shows that intravenous administration of safflower yellow as an adjunct to conventional treatment reduces urinary albumin excretion rate, fasting blood glucose, serum creatinine, and blood urea nitrogen when compared with conventional treatment alone. Overall, patients receiving safflower yellow were more likely to experience a clinical improvement in symptoms when compared with conventional treatment alone (102381).
• Familial hypercholesterolemia. Small clinical studies suggest that substituting safflower oil in place of butter in the diet may modestly reduce cholesterol levels in patients with familial hypercholesterolemia. Details: Two very small clinical studies in patients with familial hypercholesterolemia show that substituting safflower oil in place of butter in the diet (contributing 36% of daily calories) for 3 weeks decreases total and low-density lipoprotein (LDL) cholesterol levels when compared with butter (72246,72267).
• Hepatitis C. Oral safflower oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small, open-label clinical study in patients with chronic hepatitis C shows that taking a specific combination product containing safflower, pumpkin seeds, plantain seeds, and Japanese honeysuckle (EH0202) 1 gram daily for 3 months modestly reduces general discomfort, abdominal bloating, nausea, and vomiting when compared to baseline. However, hepatitis C RNA and hepatitis C virus antibody levels are not affected (72238).
• Hypertension. It is unclear if oral safflower oil is beneficial for reducing blood pressure; the available research is conflicting. Details: A very small clinical study in patients with hypertension shows that taking safflower oil 10 mL twice daily for 6-8 weeks reduces diastolic blood pressure when compared with placebo (72304). However, another small clinical study in patients with mild hypertension shows that taking safflower oil 30 mL daily for 6 weeks does not affect blood pressure when compared to baseline (72268).
• Low birth weight. It is unclear if oral safflower oil is beneficial in infants with low birth weight. Details: A small clinical study in low birth weight infants shows that fortifying formula or breast milk with a specific safflower oil product (Safola, Marico Industries Ltd.) does not improve weight gain or skin thickness when compared with coconut oil or unfortified formula or breast milk (72229).
• Metabolic syndrome. It is unclear if oral safflower oil is beneficial in patients with metabolic syndrome. Details: A small clinical study in patients with metabolic syndrome shows that taking safflower oil 2 grams four times daily for 12 weeks reduces waist circumference by 3.4 cm, systolic blood pressure by 7 mmHg, diastolic blood pressure by 3 mmHg, and fasting blood glucose by 8 mg/dL when compared with placebo. However, body weight, body mass index (BMI), and lipid levels were not affected (108889).
• Obesity. Although there has been interest in using oral safflower oil for obesity, there is insufficient reliable information about the clinical effects of safflower oil for this purpose.
• Myocardial infarction. Intravenous safflower yellow, a component of safflower flower, might improve outcomes when used as an adjunct to conventional therapy for the treatment of acute coronary syndrome (ACS). Details: A meta-analysis of 16 small, low-quality clinical trials in patients with ACS, including myocardial infarction and unstable angina, shows that intravenous administration of safflower yellow 20-40 mL daily for 10-15 days as an adjunct to conventional therapy improves clinical outcomes, electrocardiogram measures, and left ventricular ejection fraction when compared with placebo (108891).
• Phrynoderma. It is unclear if oral safflower oil is beneficial in patients with phrynoderma. Details: A small clinical study in patients with phrynoderma shows that taking 30 mL of safflower oil containing vitamin E 116 mg and linoleic acid 68% daily for more than 8 weeks can partially improve skin dryness and roughness when compared to baseline (72269). The validity of these findings is limited by the lack of a comparator group.
• Scarring. Topical safflower oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with non-hypertrophic scars and striae shows that applying an oil containing safflower oil 55.9%, olive oil 42%, grapefruit oil 2%, and tocopherol 0.1% (Kneipp Bio Skin Oil, Kneipp GmbH) to the scars and striae twice daily for 8 weeks improves scores on the Patient Scar Assessment Scale (PSAS) by 20%, compared to a 6% improvement in untreated areas (95938).
• Stroke. Small clinical studies suggest that intravenous safflower yellow, a constituent of safflower flower, as an adjunct to conventional treatments, may improve neurological outcomes post-stroke. Details: A meta-analysis of seven small, low-quality clinical studies in Chinese patients with acute ischemic stroke shows that intravenous administration of safflower yellow 100-150 mg as an adjunct to conventional treatments, starting within 72 hours of stroke onset and continuing once daily for 14 days thereafter, increases the odds of neurological improvement by about 3-fold when compared with conventional treatments alone (94038).
• Unstable angina. Intravenous safflower yellow, a component of safflower flower, might improve outcomes when used as an adjunct to conventional therapy for the treatment of unstable angina. Details: A meta-analysis of seven low-quality clinical studies in Chinese patients with unstable angina shows that intravenous safflower yellow 50-150 mg daily for 14-15 days in addition to conventional treatment modestly improves electrocardiogram (ECG) measures and symptoms of angina when compared with conventional treatment alone (94041). Another meta-analysis of 16 small, low-quality clinical trials in patients with acute coronary syndrome (ACS), including unstable angina and myocardial infarction, shows that intravenous administration of safflower yellow 20-40 mL daily for 10-15 days as an adjunct to conventional therapy improves clinical outcomes, ECG measures, and left ventricular ejection fraction when compared with placebo (108891). More evidence is needed to rate safflower for these uses.

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POSSIBLY EFFECTIVE

• Coronary heart disease (CHD). The U.S. Food and Drug Administration (FDA) allows a qualified health claim stating that using high-oleic acid sunflower oil as a replacement for other dietary fats and oils higher in saturated fat may reduce the risk of CHD. Details: A meta-analysis of clinical studies shows that replacing 7.5% of energy from partially hydrogenated vegetable oils with high-oleic acid sunflower oil can reduce CHD risk by about 9% to 19%. Furthermore, analysis of results from observational studies found that replacing partially hydrogenated oil with high-oleic acid sunflower oil is associated with a 16% to 35% reduction in the risk of CHD events (95745). The FDA allows for a qualified health claim that replacing dietary fats and oils higher in saturated fat with high-oleic acid sunflower oil may reduce the risk of CHD. To achieve this benefit, the use of high-oleic acid sunflower oil should not increase total daily energy intake. The suggested daily dietary intake is about 20 grams (1.5 tbsp) of high-oleic sunflower oil in place of other fats and oils (98563). Sunflower oil that contains high amounts of linoleic acid rather than oleic acid does not appear to improve cholesterol levels or reduce the risk of cardiovascular events in patients with CHD (96205).
• Hypercholesterolemia. Consuming sunflower oil in the diet may reduce low-density lipoprotein (LDL) cholesterol levels in some patients. Details: There is evidence that using sunflower oil in the diet as 45-50 grams daily for up to 12 weeks is more effective than olive oil for decreasing LDL cholesterol and apolipoprotein B levels in healthy individuals (9780). Also, clinical research in patients with mild hyperlipidemia or moderate hypercholesterolemia shows that consuming specific brands of mid-oleic acid (NuSun) or high-oleic acid (Sunola, Meadow Lea Foods) sunflower oils as 15% to 20% of dietary calories for up to 5 weeks is more effective than olive oil or saturated fat for decreasing total cholesterol, LDL cholesterol, and apolipoprotein B levels (76697,76698). Also, consuming a high-oleic sunflower oil-rich diet for 3 weeks decreases total cholesterol levels to a greater extent than diets enriched with palm oil or medium-chain triglycerides in patients with mild hypercholesterolemia (67569). Other preliminary clinical research in patients with moderate hypercholesterolemia shows that consuming a diet rich in sunflower oil for 3 weeks decreases total cholesterol and LDL cholesterol levels when compared with baseline. However, levels of high-density lipoprotein (HDL) cholesterol appear to be lowered as well (76714). Despite these beneficial effects, sunflower oil might be less effective than some other dietary oils. Taking sunflower oil for 3 months appears to be less effective than rice bran oil for lowering cholesterol in patients with hypercholesterolemia (76699). Also, while consuming sunflower oil 45 grams daily, as part of the diet and as a supplement, for 12 weeks reduces levels of total cholesterol and LDL cholesterol when compared to baseline, it appears to be less effective at reducing total cholesterol levels than flaxseed oil in certain patients at risk for atherosclerosis (76696). In addition, taking sunflower oil 15.1 grams daily for 4 months does not appear to reduce levels of total or LDL cholesterol in patients with peripheral vascular disease (76691).

POSSIBLY INEFFECTIVE

• Hypertension. Oral sunflower oil does not seem to lower blood pressure. Details: Preliminary clinical research in adults with hypertension shows that taking sunflower oil 30-40 grams daily for one year is less effective than extra-virgin olive oil for reducing blood pressure (5091). Also, clinical research in elderly adults with hypertension shows that taking 60 grams of sunflower oil daily for 4 weeks is less effective than virgin olive oil for reducing systolic blood pressure (76692).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Atherosclerosis. It is unclear if oral sunflower oil is beneficial for atherosclerosis; some clinical research suggests that it may provide less benefit than other dietary oils. Details: Some preliminary clinical research in individuals with overweight and obesity shows that taking sunflower oil 30 mL (about 27 grams) daily for 90 days decreases carotid intima-media thickness (CIMT) by 3.5% when compared to baseline, but not when compared with olive oil or flaxseed oil. Sunflower oil also improves flow-mediated vasodilation by 73% when compared to baseline, compared with no improvement in those taking flaxseed oil or olive oil (99303). Other preliminary clinical research in individuals waiting for carotid endarterectomy shows that taking sunflower oil 6 grams daily for up to 189 days is less effective than the same dose of fish oil, and equivalent to control oil, for improving the status of atherosclerotic plaques (76688).
• Atopic dermatitis (eczema). Although there is interest in using topical sunflower oil for atopic dermatitis, there is insufficient reliable information about the clinical effects of sunflower oil for this condition.
• Child growth. It is unclear if topical sunflower oil is beneficial for early child growth. Details: A large preliminary clinical trial in newborn infants in India shows that exclusive topical application of 10 mL of high-linoleic acid sunflower oil, an average of 2.7 times daily for about one month, increases weight gain by 1.3 gram/kg daily when compared with a control group exclusively given traditional vigorous massage with mustard oil an average of 2.4 times daily. The increase in weight gain was highest for infants weighing less than 1500-2000 grams at birth (108141). However, it is unclear if any beneficial effects are due to the sunflower oil, the massage, their combination, or the lack of mustard oil.
• Dry mouth. It is unclear if rinsing the mouth with sunflower oil is beneficial for dry mouth. Details: Preliminary clinical research in adults with moderate dry mouth associated with medication use shows that using a sunflower oil mouth rinse and gargling for 5-8 minutes before spitting it out twice daily for 7 days improves dry mouth scores by 23% when compared to baseline. Sunflower oil also improves the ability to swallow and sleep with dry mouth, but not other dry mouth symptoms or saliva flow rate, when compared with control (105523). This study may have been inadequately powered to detect a difference between groups.
• Dry skin. It is unclear if topical sunflower oil is beneficial for dry skin in infants. Details: Preliminary clinical research in full-term, newborn infants shows that topical application of 4 drops of sunflower oil to each of three parts of the body twice daily for 4 weeks improves skin hydration, but not skin barrier function or the presence of redness or rash, when compared with not using topical oil. Furthermore, use of sunflower oil may impede the normal development of skin barrier function that occurs during the first four weeks of life (96144).
• Fetal and premature infant mortality. It is unclear if topical sunflower oil is beneficial for preventing early mortality in premature infants. Details: A large clinical trial in newborn infants in India shows that exclusive topical application of 10 mL of high-linoleic acid sunflower oil, an average of 2.7 times daily for about one month, reduces infant mortality by 58% when compared to a control group exclusively given traditional vigorous massage with mustard oil an average of 2.4 times daily. A subgroup analysis of premature infants also shows a 52% reduction in mortality with the use of high-linoleic acid sunflower oil when compared with control (108143). However, it is unclear if any beneficial effects are due to the sunflower oil, the massage, their combination, or the lack of mustard oil.
• Prematurity. Small to moderate-sized clinical studies suggest that topical sunflower oil might increase body weight, reduce length of hospital stay, and improve skin hydration and skin integrity in preterm neonates. Details: Preliminary clinical research in preterm infants with low birth weight shows that massaging for 5-10 minutes using sunflower oil 10 mL/kg three times daily for 2 weeks increases weight gain by approximately 35% over 2 months when compared with massage using no oil. Sunflower oil massage does not appear to increase length or head circumference (96145). A small clinical study in premature infants in the intensive care unit (ICU) shows that a similar massage with sunflower oil three times daily for 5 days shortens ICU stay by about 5 days when compared with no massage. Furthermore, over the ICU stay, infants in the sunflower oil massage group gained an average of 15 grams, whereas infants in the control group experienced weight loss (98479). The effect of sunflower oil on skin hydration and integrity in preterm infants has also been assessed. A clinical trial of 90 preterm infants in a Turkish neonatal ICU shows that whole body skin treatment (not massage) with either sunflower oil or almond oil 4 mL/kg four times daily for 5 days improves measures of skin hydration and skin integrity when compared with control infants that did not receive oil treatment. The sunflower and almond oil treatments are equally effective (105524). Another clinical study in 90 infants (42% preterm) in a Turkish neonatal ICU shows that whole body skin treatment (not massage) with sunflower oil or liquid Vaseline 3-4 mL for preterm and 5-6 mL for full-term infants daily for 16 days improves measures of skin integrity when compared with control infants that did not receive any oil treatment. Skin integrity scores were better in the sunflower oil group than liquid Vaseline at some time points (111726).
• Psoriasis. Although there is interest in using topical sunflower oil for psoriasis, there is insufficient reliable information about the clinical effects of sunflower oil for this condition.
• Rheumatoid arthritis (RA). Although there is interest in using oral sunflower oil for RA, there is insufficient reliable information about the clinical effects of sunflower oil for this condition.
• Tinea pedis. It is unclear if topical sunflower oil is beneficial for tinea pedis. Details: Preliminary clinical research shows that topical application of a specific brand of ozonized sunflower oil (Oleozon) twice daily for 6 weeks is as effective as ketoconazole for curing athlete's foot (76687). More evidence is needed to rate sunflower oil for these uses.

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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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LIKELY SAFE ...when safflower oil is used orally as part of the diet (6,13146,72238).

POSSIBLY SAFE ...when safflower oil is used topically for up to 8 weeks (95938). ...when safflower oil is administered intravenously in recommended doses by a health care professional. A specific safflower oil emulsion (Liposyn) 10% to 20% has been used intravenously for up to 2 weeks (72300,72301). ...when safflower yellow, a component of safflower flower, is administered intravenously and appropriately. Safflower yellow has been used with apparent safety in doses up to 150 mg daily for up to 5 weeks (94038,94041,102381).

CHILDREN: POSSIBLY SAFE
when safflower oil is administered intravenously in recommended doses by a healthcare professional. A specific safflower oil emulsion (Liposyn) 20% has been used intravenously in infants and children for up to 2 weeks (72284,72295). ...when safflower oil is used orally in medicinal amounts. Safflower oil 2.5 mL daily has been taken safely for 8 weeks (94042). There is insufficient reliable information available about the safety of safflower flower in children.

PREGNANCY: LIKELY SAFE
when safflower oil is used orally as part of the diet (6,13146,72238).

PREGNANCY: POSSIBLY SAFE
when safflower oil is administered intravenously in recommended doses by a healthcare professional (20529).

PREGNANCY: LIKELY UNSAFE
when safflower flower is used due to its abortifacient, menstrual stimulant, and uterine stimulant effects (11,12).

LACTATION: LIKELY SAFE
when safflower oil is used orally as part of the diet (6,13146,72238). There is insufficient reliable information available about the safety of safflower flower during lactation; avoid using.

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LIKELY SAFE ...when used orally and appropriately in amounts commonly found in foods. When used as a substitute for other dietary oils, the recommended intake of high-oleic acid sunflower oil is 20 grams (1.5 tablespoons) daily (9780,98563). ...when used topically and appropriately, short-term. Sunflower oil has been applied to the skin twice daily for up to 6 weeks (76687). There is insufficient reliable information available about the safety of sunflower oil when used as an oral rinse.

CHILDREN: LIKELY SAFE
when used orally and appropriately in amounts commonly found in foods.

CHILDREN: POSSIBLY SAFE
when applied topically and appropriately, short-term. Sunflower oil has been applied to the skin of infants daily for up to 2 months (96144,96145,105524,108143). There is insufficient reliable information available about the safety of sunflower oil when used orally in larger amounts as medicine.

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately in amounts commonly found in foods. There is insufficient reliable information available about the safety of sunflower oil when used in amounts greater than those found in food.

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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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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B High doses of safflower oil might increase the risk of bleeding when taken with anticoagulant or antiplatelet drugs.  Details Small clinical studies show that taking safflower oil, approximately 55 grams daily for 2-3 weeks, decreases platelet aggregation (72241,72303). However, taking lower doses of safflower oil, such as 5 grams daily for 4 weeks, does not seem to affect platelet function (66267). In one case report, a 74-year-old male stabilized on warfarin developed urinary tract bleeding and an elevated INR after taking a safflower extract 20 grams daily for 14 days (95939).

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, safflower oil might alter the effects of antidiabetes drugs.  Details Some clinical research shows that taking safflower oil 10 grams daily for 3 weeks can increase fasting blood glucose in patients with type 2 diabetes (13146). However, clinical research in patients with metabolic syndrome with or without impaired glucose tolerance shows that taking safflower oil 8 grams daily for 12 weeks reduces fasting glucose levels by around 8 mg/dL (108889). Some clinical research also shows that taking safflower oil 8 grams daily for 16 weeks does not affect fasting glucose levels in patients with type 2 diabetes (94039).

WARFARIN Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, safflower oil might increase the risk of bleeding when taken with warfarin.  Details In one case report, a 74-year-old male stabilized on warfarin developed urinary tract bleeding and an elevated INR after taking a safflower extract 20 grams daily for 14 days (95939).

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ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, sunflower oil might decrease the effectiveness of antidiabetes medications.  Details A diet using sunflower oil as a fat source can cause increased fasting blood glucose levels in patients with type 2 diabetes (8132). Dose adjustments to diabetes medications might be necessary.

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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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General ...Orally and intravenously, safflower oil seems to be well tolerated.
Serious Adverse Effects (Rare):
Orally: Liver failure.

Dermatologic ...Intravenously, safflower yellow, a constituent of safflower flower, can cause skin rash (94038,94041). In one case, adjusting the rate of the drip improved the rash (94041).

Hepatic ...Orally, safflower oil has been associated with liver failure. There are at least 7 case reports of acute liver failure requiring liver transplant that are probably associated with over-use of safflower oil, usually for weight loss purposes. However, it is not clear what dose or duration of safflower use led to liver failure in these cases (99138).

Immunologic ...Safflower can cause an allergic reaction in individuals sensitive to the Asteraceae/Compositae family. Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs.

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General ...Orally and topically, sunflower oil is well tolerated.
Serious Adverse Effects (Rare):
Orally: Allergic reactions in sensitive individuals have been reported.

Immunologic ...Orally, sunflower oil can cause an allergic reaction in individuals sensitive to the Asteraceae/Compositae family. Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs. However, the protein content of sunflower oil is very low. In one case report, an allergic response to sunflower oil did not occur despite presenting with severe allergy and anaphylaxis to sunflower seed (108140).

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