ProHydra-7 [Discontinued] by EuroMedica

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Dyspepsia. Oral olive leaf extract has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small study in healthy adults shows that taking a specific combination product containing olive leaf extract 24% and prickly pear cactus 33% (Mucosave, Bionap S.R.L.) 400 mg daily for 8 weeks seems to improve dyspepsia and other gastrointestinal symptoms when compared with placebo (105904). It is unclear if this benefit would occur in patients with clinically diagnosed dyspepsia.
• Exercise-induced respiratory infections. It is unclear if oral olive leaf extract is beneficial for reducing respiratory infections from exercise. Details: A small clinical study in high school athletes shows that taking one tablet of olive leaf extract providing eleuropein 100 mg daily for 2 months during training season does not reduce the incidence of the common cold when compared with placebo. While it may reduce the number of sick days by 28%, a sub-group analysis suggests that this reduction is only evident in female athletes (101860).
• Gastroesophageal reflux disease (GERD). Although there is interest in using oral olive leaf for GERD, there is insufficient reliable information about the clinical effects of olive for this condition.
• Herpes zoster (shingles). Although there is interest in using oral olive leaf for shingles, there is insufficient reliable information about the clinical effects of olive for this condition.
• Influenza. Although there is interest in using oral olive leaf for influenza, there is insufficient reliable information about the clinical effects of olive for this condition.
• Metabolic syndrome. It is unclear if oral olive leaf extract is beneficial for improving body composition and cardiovascular risk factors in patients with metabolic syndrome. Details: A small clinical trial in overweight, middle-aged males at risk for metabolic syndrome shows that taking four capsules of olive leaf extract providing oleuropein 51.1 mg and hydroxytyrosol 9.7 mg daily for 12 weeks improves insulin sensitivity by 15% when compared with placebo. However, body composition, blood pressure, cholesterol levels, and other cardiovascular risk factors were not improved (92245).
• Osteoarthritis. It is unclear if oral olive fruit or leaf extract is beneficial for improving osteoarthritis. Details: Preliminary clinical research shows that taking a freeze-dried aqueous extract of olive fruit 400 mg daily for 8 weeks decreases pain and increases mobility in people with osteoarthritis (14844). Other preliminary clinical research in adults with knee osteoarthritis shows that taking olive leaf extract 50.1 mg daily for 4 weeks improves overall pain measurements by 14%, compared to only 4% in the placebo group. However, many individual measurements of pain are not improved (92252).
• Osteoporosis. It is unclear if oral olive leaf extract is beneficial for osteoporosis. Details: Clinical research shows that taking olive leaf extract (Bonolive, BioActor BV) 250 mg daily for 12 months, along with elemental calcium 400 mg daily, increases osteocalcin levels by about 32% when compared to baseline; this increase was significant when compared to those taking calcium 400 mg plus placebo, who showed a 6% decrease in osteocalcin levels. However, taking olive leaf extract does not significantly increase bone mineral density of the lumbar spine or femur neck when compared with placebo (92247).
• Rheumatoid arthritis (RA). It is unclear if oral olive fruit extract is beneficial for improving RA symptoms. Details: Preliminary clinical research in adults with RA shows that taking an aqueous freeze-dried extract of olive fruit 400 mg daily for 8 weeks does not improve symptoms when compared with control (14844). More evidence is needed to rate the effectiveness of olive for these uses.

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POSSIBLY INEFFECTIVE

• Cardiovascular disease (CVD). Most research suggests that increasing dietary intake of omega-6 fatty acids does not reduce the risk of CVD. Details: A meta-analysis including 19 low-quality randomized controlled trials that followed patients for 1-8 years shows that higher intake of omega-6 fatty acids for at least 12 months does not reduce the risk of primary or secondary CVD events, coronary heart disease (CHD) events, stroke, or all-cause or CVD mortality when compared with a lower intake. The intake of omega-6 fatty acids ranged from 0.8% to 20.6% of energy (99973). Population research conducted over about 7.3 years has also found that baseline red blood cell omega-6 fatty acid levels are not associated with CVD events, CHD events, ischemic strokes, CVD deaths, or all-cause mortality (99974), and red blood cell omega-6 fatty acid levels do not differ between people with or without coronary artery disease in patients hospitalized for coronary angiography (96918). However, some research suggests that individual omega-6 fatty acids may have differing effects in the body. One population study has found that increased levels of shorter chain omega-6 fatty acids in red blood cells, including linoleic acid, gamma linolenic acid, and dihomo-gamma linolenic acid, are associated with a reduced risk of CVD mortality. Higher levels of the longer chain omega-6 fatty acids adrenic acid and docosapentaenoic acid are associated with a moderately increased risk of overall mortality in these patients (96918). Higher quality studies are needed to confirm these findings.
• Child development. Most research suggests that supplementing infant formula with arachidonic acid, an omega-6 fatty acid, and docosahexaenoic acid (DHA), an omega-3 fatty acid, does not improve infant or child development. Details: Meta-analyses of clinical research show that inclusion of arachidonic acid in infant formula at levels of up to 0.84% of fatty acids, in addition to DHA, for 2-12 months does not improve visual or neurodevelopmental outcomes in preterm or full-term infants up to 18 months of age (96919,96920). Also, giving infants DHA- and arachidonic acid-supplemented formula during infancy does not appear to improve neurodevelopment by the age of 6 years (92503).
• Hyperlipidemia. Increasing dietary intake of omega-6 fatty acids does not seem to lower plasma cholesterol or triglyceride levels. Details: A meta-analysis of clinical research shows that increasing intake of omega-6 fatty acids, specifically linoleic acid or gamma-linolenic acid, by replacing dietary saturated or monounsaturated fatty acids modestly reduces levels of total cholesterol. However, the clinical significance is unclear. Also, increasing intake of omega-6 fatty acids does not seem to affect levels of high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, or triglycerides (99973).
• Multiple sclerosis (MS). Most research suggests that taking omega-6 fatty acids is not beneficial for MS. Details: A meta-analysis of the available literature shows that taking omega-6 fatty acids, mainly as linoleic acid, does not seem to prevent disease progression in relapsing-remitting MS patients or chronic progressive MS patients at 24 months (107318).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Age-related cognitive decline. It is unclear if increased dietary omega-6 fatty acid intake is beneficial for preventing age-related cognitive decline. Details: Population research has found that the highest blood levels of omega-6 fatty acids during middle age are associated with the best overall cognitive functioning 13 years later when compared with lower intakes (99979). In addition, the highest tertile of omega-6 fatty acid intake in older adults, at least 8.8 mg per kcal daily, is inversely associated with having low cognitive performance. However, the same pattern was observed for the highest tertile of omega-3 fatty acids, and the omega-6 to omega-3 fatty acid ratio in the diet had no overall association with cognitive performance (103308).
• Attention deficit-hyperactivity disorder (ADHD). Oral omega-6 fatty acids have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research shows that taking a combination of omega-3 and omega-6 fatty acids twice daily for 3-6 months does not improve symptoms of ADHD in most children when compared with placebo, although it may improve ADHD symptoms in a subgroup of children with ADHD inattentive subtype plus comorbid neurodevelopmental disorders (65864).
• Blepharitis. It is unclear if oral omega-6 fatty acids are beneficial for blepharitis. Details: One preliminary clinical study in patients with Meibomian gland dysfunction shows that taking a specific product (Medilar, Fidia Oftal Bausch & Lomb Pharmaceuticals), which contains the omega-6 fatty acids linoleic acid 28.5 mg and gamma-linolenic acid 15 mg, once daily for 180 days in combination with eyelid hygiene can improve cloudiness from eye secretions and gland obstruction when compared with baseline (66665). However, the lack of a control group limits the validity of these results. Population research involving postmenopausal adults has also found that moderate dietary intake of omega-6 fatty acids is associated with a reduced risk of developing Meibomian gland dysfunction. However, high intake was not associated with a reduced risk in these patients, and the protective effect of omega-6 fatty acids, if any, in the general population is unclear (99978). Higher quality research is needed to confirm these results.
• Cancer. It is unclear if increased dietary intake of omega-6 fatty acids is beneficial for cancer prevention. Details: In a meta-analysis of clinical research, increasing intake of dietary omega-6 fatty acids does not seem to reduce cancer risk or mortality. However, the included research is of low quality (107005). Also, a meta-analysis of population research has found that dietary intake of omega-6 fatty acids is not associated with cancer risk. However, high blood levels of omega-6 fatty acids were associated with an 8% reduced risk of cancer when compared to low blood levels, with breast cancer carrying the strongest association. Each 5% increase in blood levels of omega-6 fatty acids was associated with a 2% decreased cancer risk (107006). These results should be interpreted with caution, since factors other than omega-6 fatty acid intake, such as alcohol intake or overall diet, may affect blood levels of omega-6 fatty acids (100516).
• Developmental coordination disorder (DCD). Oral omega-6 fatty acids have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research shows that taking a combination of omega-6 and omega-3 fatty acids for 3 months can improve reading, spelling, and behavior, but not motor skills, when compared with placebo in children with DCD (13748).
• Diabetes. It is unclear if higher dietary or supplemental intake of omega-6 fatty acids is associated with a reduced risk of diabetes. Details: Population research has found that the highest blood levels of the omega-6 fatty acid linoleic acid are associated with a 43% reduced risk of developing diabetes over a period of 5-42 years when compared with the lowest blood levels. Blood levels of another omega-6 fatty acid, arachidonic acid, do not seem to be linked to diabetes risk (96914). These results should be interpreted with caution, since factors other than omega-6 fatty acid intake, such as alcohol intake or overall diet, may affect blood levels of omega-6 fatty acids (100516). In addition, a meta-analysis of low-quality clinical research does not support any benefit of omega-6 fatty acids in the prevention or treatment of type 2 diabetes (101504).
• Diarrhea. It is unclear if formula supplemented with arachidonic acid is beneficial for diarrhea prevention in infancy. Details: Preliminary clinical research shows that infant formula supplemented with arachidonic acid 34 mg/100 kcal and docosahexaenoic (DHA) acid, an omega-3 fatty acid, 17 mg/100 kcal (Enfamil Premium 1 and Enfamil Premium 2, Mead Johnson Nutrition) can reduce the incidence of diarrhea in the first year of life when compared with non-supplemented infant formula (92505).
• Dry eye. It is unclear if dietary intake of omega-6 fatty acids is beneficial for dry eye prevention. Details: Population research has found that higher intake of dietary omega-6 fatty acids is not associated with a reduced risk of dry eye after menopause (99978).
• Hypertension. It is unclear if dietary intake of omega-6 fatty acids is beneficial for blood pressure reduction. Details: Population research has found that higher dietary intake of omega-6 fatty acids, especially linoleic acid, is inversely associated with the odds of hypertension in non-diabetic individuals. However, in patients with diabetes, higher intake of omega-6 fatty acids is associated with an increased odds of hypertension (99975).
• Nonalcoholic fatty liver disease (NAFLD). It is unclear if dietary intake of omega-6 fatty acids is beneficial for NAFLD prevention. Details: Cross-sectional population research is mixed with respect to dietary intake of omega-6 fatty acids in patients with NAFLD when compared with healthy controls. One large cross-sectional study based on data from the National Health and Nutrition Examination Survey (NHANES) between 2007-2014 has found that consuming omega-6 fatty acids at a dose of at least 250 mg/kg daily is associated with an 82% reduced risk of having NAFLD when compared with consuming less than 121.3 mg/kg daily (107002).
• Obesity. It is unclear if oral omega-6 fatty acids are beneficial for reducing cholesterol or triglyceride levels in adults with obesity. Details: In individuals with abdominal obesity, a small clinical trial shows that taking linoleic acid 15 grams (females) or 20 grams (males) (Pharmatech AS) daily for 7 weeks from safflower oil has modest beneficial effects on levels of low-density lipoprotein (LDL)-, high-density lipoprotein (HDL)-, and total cholesterol when compared with baseline or taking fish oil. However, there was no effect on triglyceride levels (107003).
• Photoreactive keratectomy. Oral omega-6 fatty acids have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research in patients who have undergone photoreactive keratectomy shows that taking a tablet containing the omega-6 fatty acids linoleic acid and gamma-linolenic acid, as well as beta-carotene, B vitamins, and trace minerals, daily for 30 days can improve tear production and eye healing when compared with a control group (66679).
• Respiratory tract infections. It is unclear if supplementing infant formula with arachidonic acid is beneficial for preventing respiratory tract infections. Details: Preliminary clinical research shows that infant formula supplemented with arachidonic acid 34 mg/100 kcal and docosahexaenoic acid (an omega-3 fatty acid) 17 mg/100 kcal (Enfamil Premium 1 and Enfamil Premium 2, Mead Johnson Nutrition) can reduce the incidence of respiratory illness in the first year of life when compared with non-supplemented infant formula (92505). More evidence is needed to rate omega-6 fatty acids for these uses.

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POSSIBLY EFFECTIVE

• Burns. Topical cream containing sea buckthorn seems to improve burn healing. Details: Clinical research in patients with second-degree burn injuries shows that topical application of sea buckthorn 40% cream once daily reduces healing time by about 4.5 days when compared with a specific cream containing silver sulfadiazine 1% (Flamexin, Sina Daru) (106091).

POSSIBLY INEFFECTIVE

• Atopic dermatitis (eczema). Neither oral nor topical sea buckthorn products seem to be beneficial for atopic dermatitis. Details: Preliminary clinical research shows that taking sea buckthorn seed and pulp oils 5 grams daily orally for 4 months may improve the severity of atopic dermatitis when compared to pretreatment; however, treatment with the same dose of sea buckthorn seed oil does not have this effect, and the effect of sea buckthorn pulp oil does not appear to be significantly different than placebo (74021). Additionally, applying sea buckthorn 10% or 20% cream topically for 4 weeks does not seem to reduce the severity of atopic dermatitis when compared with placebo in patients with mild-to-moderate atopic dermatitis (74091).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. Although there is interest in using topical sea buckthorn for acne, there is insufficient reliable information about the clinical effects of sea buckthorn for this condition.
• Aging skin. Although there is interest in using oral or topical sea buckthorn for aging skin, there is insufficient reliable information about the clinical effects of sea buckthorn for this purpose.
• Asthma. Although there is interest in using oral sea buckthorn for asthma, there is insufficient reliable information about the clinical effects of sea buckthorn for this condition.
• Cancer. Although there is interest in using oral sea buckthorn for reducing morbidity related to cancer and side effects related to chemotherapy, there is insufficient reliable information about the clinical effects of sea buckthorn for these uses.
• Cirrhosis. It is unclear if oral sea buckthorn is beneficial for patients with cirrhosis. Details: Preliminary clinical research shows that taking sea buckthorn extract 15 grams three times daily for 6 months might reduce liver enzymes and markers of liver inflammation in patients with cirrhosis when compared with a control group taking vitamin B complex (16694).
• Common cold. It is unclear if oral sea buckthorn is beneficial for preventing or treating the common cold. Details: Clinical research in healthy volunteers shows that consuming sea buckthorn berries 28 grams daily in frozen puree for 90 days does not reduce the risk of developing the common cold or reduce the duration of symptoms of the common cold when compared with placebo (16692).
• Diabetes. Although there is interest in using oral sea buckthorn for diabetes, there is insufficient reliable information about the clinical effects of sea buckthorn for this condition.
• Dry eye. It is unclear if oral or topical sea buckthorn is beneficial for dry eye. Details: Preliminary clinical research in adults with dry eye shows that taking a specific sea buckthorn seed and pulp oil product (Omega-7, Aromtech Ltd.) 1 gram orally twice daily for 3 months reduces subjective assessments of eye redness and burning and reduces tear film osmolarity when compared with placebo (17406,74069). Preliminary clinical research also shows that using an eyelid spray containing sea buckthorn seed oil 0.4% and sodium hyaluronate 0.02% (Aromtech Ltd., and Finnsusp Ltd.) four times daily for 1.5 months reduces symptoms of dryness and watering by a small amount when compared to a control spray. However, there was no effect on feelings of grittiness, burning, redness, or other symptoms (102845).
• Dry skin. Although there is interest in using topical sea buckthorn for dry skin, there is insufficient reliable information about the clinical effects of sea buckthorn for this condition.
• Dyslipidemia. It is unclear if oral sea buckthorn is beneficial for hyperlipidemia. Details: Some clinical research shows that sea buckthorn berries and extracts can improve the lipid profile in people with hyperlipidemia and/or nonalcoholic fatty liver disease (NAFLD). In a meta-analysis of 11 studies from China and Finland, consuming sea buckthorn berries or extracts for between 12 days and 4 months decreased total cholesterol and low-density lipoprotein (LDL) cholesterol by about 24 mg/dL and triglycerides by about 41 mg/dL and increased high-density lipoprotein (HDL) cholesterol by about 10 mg/dL when compared with baseline or a control group (96555). The sea buckthorn doses and formulations used in these studies were not identified. Additionally, a very small clinical study in females aged 50-61 with hypercholesterolemia shows that drinking sea buckhorn juice (ZAMIO, Ltd) 100% 50 mL daily for 8 weeks modestly improves HDL by about 2 mg/dL and LDL by 10 mg/dL, but does not impact total cholesterol or triglycerides when compared to baseline (112171). However, the validity of these findings is limited by the lack of a comparator group. In contrast, clinical research in patients with hypercholesterolemia shows that taking sea buckthorn puree 30 grams three times daily for 90 days does not improve lipid markers or blood pressure when compared with placebo (106090).
• Dyspepsia. It is unclear if oral sea buckthorn is beneficial for dyspepsia. Details: Preliminary clinical research shows that taking sea buckthorn dry emulsion (prepared with the fruit juice and oil) daily for 8 weeks increases levels of the appetite regulators leptin and neuropeptide Y, which tend to be lower in children with functional dyspepsia; however, sea buckthorn does not appear to improve gastric emptying rates in these patients. Doses were administered according to age: 2.5 grams twice daily for children aged 1-3 years, 5 grams twice daily for children aged 4-6 years old, and 7.5 grams twice daily for children aged 7 years (94800).
• Gout. Although there is interest in using oral sea buckthorn for gout, there is insufficient reliable information about the clinical effects of sea buckthorn for this condition.
• Hypertension. It is unclear if oral sea buckthorn is beneficial for hypertension. Details: A meta-analysis of preliminary clinical research in patients with essential hypertension shows that taking sea buckthorn flavones 10-30 mg three times daily for 1-8 months reduces systolic and diastolic blood pressure to a similar extent as calcium channel blockers and angiotensin converting enzyme (ACE) inhibitors (74090).
• Impaired glucose tolerance (prediabetes). It is unclear if oral sea buckthorn is beneficial for prediabetes. Details: A small clinical trial in patients with impaired glucose tolerance shows that taking sea buckthorn fruit puree 90 mL daily in three divided doses for 5 weeks modestly reduces fasting levels of blood glucose when compared with taking placebo. There was no effect on postprandial glucose levels or blood pressure (106088).
• Kidney failure. It is unclear if oral sea buckthorn oil is beneficial for patients on hemodialysis. Details: Preliminary clinical research shows that taking sea buckthorn oil 2 grams daily for 8 weeks does not improve levels of urea, creatinine, or calcium, reduce markers of inflammation, or improve salivary flow rate when compared with placebo in patients with chronic kidney disease (CKD) who are receiving hemodialysis (94798).
• Melasma. Although there is interest in using topical sea buckthorn for melasma, there is insufficient reliable information about the clinical effects of sea buckthorn for this condition.
• Nephrotic syndrome. It is unclear if oral sea buckthorn is beneficial for nephrotic syndrome. Details: Preliminary clinical research in patients with idiopathic nephrotic syndrome shows that taking hydroalcoholic extract of sea buckthorn 350 mg orally twice daily for 3 months in addition to standard therapy reduces edema, anorexia, and the extent of proteinuria when compared to baseline. It is unclear if the effects of sea buckthorn plus standard therapy are significantly better than the effects of standard therapy alone (94799).
• Obesity. It is unclear if oral sea buckthorn is beneficial for obesity. Details: Preliminary clinical research shows that taking sea buckthorn berries, berry oil, or phenolic alcoholic extract does not reduce body weight in overweight or obese females, although it seems to reduce low-density lipoprotein (LDL) cholesterol (35463,94796).
• Peptic ulcers. Although there is interest in using oral sea buckthorn for peptic ulcers, there is insufficient reliable information about the clinical effects of sea buckthorn for this condition.
• Psoriasis. It is unclear if topical sea buckthorn is beneficial for psoriasis. Details: One small clinical study in patients with previously untreated psoriasis shows that topically applying an unknown amount of sea buckthorn fruit extract suspended in corn oil twice daily for 8 weeks reduces the severity of psoriasis lesions when compared with corn oil alone (102844).
• Radiation dermatitis. Although there is interest in using topical sea buckthorn for radiation dermatitis, there is insufficient reliable information about the clinical effects of sea buckthorn for this condition.
• Rheumatoid arthritis (RA). Although there is interest in using oral sea buckthorn for RA, there is insufficient reliable information about the clinical effects of sea buckthorn for this condition.
• Sunburn. Although there is interest in using topical sea buckthorn for sunburn prevention, there is insufficient reliable information about the clinical effects of sea buckthorn for this condition.
• Vaginal atrophy. It is unclear if oral or intravaginal sea buckthorn is beneficial for vaginal atrophy. Details: Preliminary clinical research shows that taking 3 grams of sea buckthorn oil daily for 3 months does not improve vaginal dryness, itching, burning, pH, or elasticity when compared with placebo in postmenopausal individuals with vaginal atrophy (94797). Topical sea buckthorn oil has also been evaluated, in combination with other ingredients. Clinical research in adults with postmenopausal vulvovaginal atrophy shows that intravaginal application of a specific gel (Meclon Idra Alfasigma, Giellepi) containing sea buckthorn oil, aloe vera, 18-beta-glycyrrhetic acid, hyaluronic acid, and glycogen modestly improves sexual function and reduces vaginal pain, dyspareunia, and symptoms such as vaginal dryness, itching, and burning when compared with a placebo gel. The gel was used daily for 14 days and then twice weekly for 60 days after a 2-week washout (106089). It is unclear if these benefits are due to sea buckthorn oil, other ingredients, or the combination.
• Wound healing. Although there is interest in using topical sea buckthorn for healing of pressure ulcers, skin ulcers, or other wounds, there is insufficient reliable information about the clinical effects of sea buckthorn for this purpose.
• Wrinkled skin. Oral sea buckthorn oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in people with facial photodamage and severe fine wrinkling shows that taking a specific combination product (GliSODin Skin Nutrients Advanced Anti-Aging Formula, Isocell North America Inc.) as one capsule orally three times daily for 90 days, in addition to applying tazarotene 0.1% cream, improves the appearance of wrinkles, hyperpigmentation, and photodamage when compared with using tazarotene 0.1% cream alone. Three capsules of this product contain sea buckthorn berry oil 200 mg, krill oil 600 mg, zinc 10 mg, vitamin D 400 IU, cacao bean extract 100 mg, hyaluronic acid 30 mg, red clover flower isoflavones 30 mg, and a specific proprietary ingredient called GliSODin 500 mg (91778). It is not clear if these effects are due to sea buckthorn, the other ingredients, or the combination. More evidence is needed to rate sea buckthorn for these uses.

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LIKELY SAFE ...when olive fruit is used orally and appropriately in amounts commonly found in foods.

POSSIBLY SAFE ...when olive leaf extract is used orally and appropriately. Olive leaf extract providing 51-100 mg oleuropein daily has been used with apparent safety for 6-8 weeks (92245,92247,101860). There is insufficient reliable information available about the safety of olive fruit extract when used in amounts greater than those found in foods.

PREGNANCY AND LACTATION:
Insufficient reliable information available; stick with amounts commonly found in foods.

(Read more about OLIVE)

LIKELY SAFE ...when used orally in amounts found in foods. Dietary intake in amounts of 5% to 10% of daily calories are appropriate according to the Dietary Reference Intake (DRI) Acceptable Macronutrient Distribution Range (AMDR) (23723). There is insufficient reliable information available about the safety of omega-6 fatty acids when used orally in medicinal amounts.

CHILDREN: LIKELY SAFE
when consumed by children over the age of 12 months as part of the diet in amounts between 5% to 10% of daily calories according to the Dietary Reference Intake (DRI) Acceptable Macronutrient Distribution Range (AMDR) (23723).

PREGNANCY AND LACTATION: LIKELY SAFE
when consumed as part of the diet in amounts between 5% and 10% of daily calories according to the Dietary Reference Intake (DRI) Acceptable Macronutrient Distribution Range (AMDR) (23723).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when high amounts of omega-6 fatty acids are consumed in the diet. Population research suggests that the highest maternal intakes of omega-6 fatty acids (15.2-47.6 grams or 137-428 kcal daily) during pregnancy is associated with a 2.4-times greater odds of giving birth to an infant below the 10th percentile for birth weight when compared with the lowest maternal intakes (0.4-5.7 grams daily) (96913). In addition, population research in women with a history of atopy suggests that the highest blood levels of omega-6 fatty acids during the second trimester is associated with an increased odds of having a child develop atopic dermatitis by age 4-6 years when compared with the lowest intakes (103309). There is insufficient reliable information available about supplemental omega-6 fatty acids; avoid using.

(Read more about OMEGA-6 FATTY ACIDS)

LIKELY SAFE ...when sea buckthorn fruit is consumed as food. Sea buckthorn fruit is used in jams, jellies, pies, juices, and sauces (9898).

POSSIBLY SAFE ...when sea buckthorn fruit or fruit extract is used orally and appropriately for medicinal purposes. The oil extract of the fruit and seed have been used with apparent safety in doses of up to 2 grams daily for up to 3 months (16692,17406). ...when sea buckthorn fruit is used topically and appropriately. A cream containing sea buckthorn fruit 40% daily has been used with apparent safety for up to 13 days (106091). There is insufficient reliable information available about the safety of sea buckthorn leaf or leaf extracts when used orally or topically.

CHILDREN: POSSIBLY SAFE
when used orally and appropriately for medicinal purposes. Sea buckthorn dry emulsion (prepared with the fruit juice and oil) 5-15 grams daily for 8 weeks has been used with apparent safety in children 1-7 years of age (94800).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Theoretically, sea buckthorn may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.  Details Clinical research suggests that sea buckthorn fruit extracts can inhibit platelet aggregation and adhesion to collagen and fibrinogen (10208,96554).

ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking sea buckthorn with antihypertensive drugs might increase the risk of hypotension.  Details Taking sea buckthorn appears to reduce blood pressure in some patients (74090).

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General ...Orally, olive fruit is well tolerated when used in typical food amounts. Olive leaf extract seems to be well tolerated.
Most Common Adverse Effects:
Orally: Headache and stomach discomfort.

Dermatologic ...Orally, one patient in one clinical trial reported bad skin and acne after using olive leaf extract (101860).

Gastrointestinal ...Orally, three patients in one clinical trial reported stomach ache after using olive leaf extract (101860).

Neurologic/CNS ...Orally, three patients in one clinical trial reported headache after using olive leaf extract (101860).

Psychiatric ...In one case report, a 67-year-old female experienced irritability, anger, a lack of control, and feelings of sadness and negativity after consuming a multi-ingredient product containing olive leaf extract 5 grams, horseradish root, and eyebright daily for 38 days. All psychiatric symptoms disappeared within days of stopping the combined product. It is hypothesized that the hydroxytyrosol component of olive leaf extract contributed to these symptoms due to its chemical similarity to dopamine; however, it is not clear if these symptoms were due to the olive leaf extract or to the other ingredients (96245).

Pulmonary/Respiratory ...Olive tree pollen can cause seasonal respiratory allergy (1543).

(Read more about OLIVE)

General ...Orally, consuming omega-6 fatty acids in amounts found in foods is well tolerated.

Cardiovascular ...Dietary intake of the omega-6 fatty acid linoleic acid in amounts of 5% to 10% of daily calories is appropriate according to the Dietary Reference Intake (DRI) Acceptable Macronutrient Distribution Range (AMDR) (23723). However, higher intake levels, especially when compared with omega-3 fatty acid intake, might be detrimental. For example, a higher ratio of dietary omega-6 to omega-3 fatty acids is thought to increase the risk of cardiovascular disease compared to a lower ratio (66678). However, the American Heart Association Nutrition Subcommittee of the Council on Nutrition, Physical Activity, and Metabolism, the Council on Cardiovascular Nursing, and the Council on Epidemiology and Prevention, suggest that reduction of omega-6 fatty acids in the diet is unlikely to be beneficial for the cardiovascular system if replaced with saturated or trans-fatty acids (66692). Population research has found that higher intake of omega-6 fatty acids might be associated with hypertension and increased levels of plasma homocysteine, a risk factor for cardiovascular disease and atherosclerosis (65498,66640,66642).

Musculoskeletal ...In epidemiological research, increased intake of omega-6 fatty acids was associated with elevated risk of fracture in the elderly (66662).

Neurologic/CNS ...In epidemiological research, an increased dietary ratio of omega-6 fatty acids to omega-3 fatty acids has been associated with an elevated risk of having a sleep disorder (107001).

Oncologic ...Some population research has found that high omega-6 fatty acid intake or blood levels are associated with an increased risk for cancer, including breast cancer and prostate cancer (3508,7824,66660,66664,66729).

Psychiatric ...In epidemiological research, adolescents with attention-deficit hyperactivity disorder (ADHD) had higher levels of omega-6 and lower levels of omega-3 fatty acids in red blood cells (48200). The role of omega-6 fatty acids in ADHD is unclear; it is possible that the low levels of omega-3 fatty acids and essential fatty acids in general may be playing a role. Also, higher levels of some omega-6 fatty acids in the body are associated with greater depressive symptomology and neuroticism (65815,66659). Higher concentrations of some omega-6 fatty acids in red blood cells of patients with schizophrenia are correlated with positive schizotypal trait measures in healthy adults (66635). This may be related to increased intake of omega-6 fatty acids in the diet of patients with schizophrenia (96916).

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General ...Orally, sea buckthorn is well tolerated. Topically, sea buckthorn fruit seems to be well tolerated.
Most Common Adverse Effects:
Topically: Irritation and rash.

Dermatologic ...Orally, high doses of sea buckthorn may cause yellow staining of the skin. One case of generalized yellow skin has been reported for a patient who consumed sea buckthorn 100 grams daily for 6 months (74072). Topically, sea buckthorn oil has been associated with dryness, irritation, redness, and rash (74077,102845). Rash occurred in 4% of patients in one clinical study (74077). When used intravaginally, severe burning and itching have been reported rarely (106089).

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