3 Brains Total - Phosphatidylserine by Natural Factors Three Brains

POSSIBLY EFFECTIVE

• Age-related cognitive decline. Oral bovine cortex-derived phosphatidylserine seems to improve attention and memory in patients with age-related cognitive decline. It is unclear if plant-derived phosphatidylserine is beneficial or whether phosphatidylserine is beneficial for preventing cognitive decline. Details: Clinical studies in people with age-related cognitive decline show that phosphatidylserine improves attention, arousal, verbal fluency, and memory (2440,2441,7119,7120,15539). Bovine- and plant-sourced phosphatidylserine 100 mg three times daily for up to 6 months has been used in these studies (2440,2441,15539). Most clinical studies have used phosphatidylserine derived from bovine cortex. However, most supplements now use soy- or cabbage-derived phosphatidylserine. There is some preliminary evidence that plant-derived phosphatidylserine also improves memory in people with age-associated memory impairment (15539). Also, clinical research in elderly females with complaints of memory loss shows that taking 1-3 capsules of a specific product (Vayacog, Enzymotec Ltd.) containing soybean-derived phosphatidylserine 100 mg/capsule, enriched with docosahexaenoic acid (DHA) 19.5 mg/capsule and eicosapentaenoic acid (EPA) 6.5 mg/capsule, daily for 15 weeks modestly improves immediate memory and sustained attention when compared with placebo (66055,90711). A post-hoc analysis of the results from this study suggests that cognitive improvements are greatest in patients with relatively good cognitive performance at baseline (66055). There is also interest in using phosphatidylserine to prevent age-related cognitive decline. In 2003, the US Food and Drug Administration (FDA) determined that it would allow a qualified health claim stating that consuming phosphatidylserine may reduce the risk of developing age-related cognitive decline. However, the FDA has determined that there is very little scientific evidence supporting this claim (102363).
• Alzheimer disease. Oral bovine cortex-derived phosphatidylserine seems to improve cognitive function and behavior in patients with Alzheimer disease when used for up to 12 weeks, although benefits may disappear after 16 weeks. It is unclear if plant-derived phosphatidylserine is beneficial. Details: Taking phosphatidylserine orally can improve cognitive function and global improvement rating scales and improve behavioral rating scales over 6-12 weeks of treatment (2255,2437,2438,2439,7114,7118). Bovine-sourced phosphatidylserine 300-400 mg in divided doses daily for up to 16 weeks has been used (2255,2437,2438,2439). Phosphatidylserine seems to be most effective in patients with less severe symptoms (2437,2439). Phosphatidylserine might lose its effectiveness with extended use. After 16 weeks of treatment, progression of Alzheimer disease seems to overcome any benefit of phosphatidylserine (2255). Most clinical studies have used phosphatidylserine derived from bovine cortex. However, most supplements now use soy- or cabbage-derived phosphatidylserine. Clinical studies have not yet evaluated phosphatidylserine from soy or other sources. It is not known if phosphatidylserine from these sources is as effective as bovine-derived products.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Athletic performance. It is unclear if oral phosphatidylserine is beneficial for athletic performance. Details: One small clinical trial in golfers shows that taking nutritional bars containing phosphatidylserine 200 mg daily for 6 weeks improves the number of good ball flights, which may improve golf score; however, perceived stress levels and heart rate are not significantly affected (68855). A clinical study in recreationally active adults shows that taking phosphatidylserine 400 mg and caffeine 100 mg daily, along with niacin 28 mg, vitamin C 60 mg, vitamin B1 1.5 mg, vitamin B5 10 mg, vitamin B6 2 mg, vitamin E 12 IU, calcium 100 mg, magnesium 40 mg, and carbohydrates in the form of evaporated cane juice, brown rice syrup, and rice syrup solids 16 grams (Nutravail Technologies) for 14 days modestly reduces post-exercise mood disturbances and perception of fatigue when compared with vitamins and minerals alone. The combination does not appear to improve cognitive function or reaction time (91463). It is not clear if the effect of the combination supplement is due to phosphatidylserine, caffeine, or the combination.
• Attention deficit-hyperactivity disorder (ADHD). It is unclear if oral phosphatidylserine is beneficial for ADHD. Details: A meta-analysis of three generally low-quality randomized clinical trials shows that taking phosphatidylserine 200-300 mg daily for 8-15 weeks modestly improves symptoms of inattention in children with ADHD when compared with placebo. However, there were no significant effects on hyperactivity-impulsivity or on overall ADHD symptoms. Also, two of the three clinical trials included in the analysis investigated the effects of phosphatidylserine in combination with the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (105247). One preliminary clinical trial included in the analysis shows that taking soy-derived phosphatidylserine 200 mg daily for 2 months improves ADHD symptoms, including inattention, hyperactivity-impulsivity, and short-term memory, when compared to baseline in treatment-naïve children with ADHD aged 4-14 years. However, results from this study are limited due to a lack of statistical comparison to the placebo group (89498).
• Cognitive function. Although there is interest in using oral phosphatidylserine for improving cognitive function in healthy adults, there is insufficient reliable information about the clinical effects of phosphatidylserine for this purpose.
• Dementia. It is unclear if oral phosphatidylserine is beneficial for dementia prevention or treatment. Details: In 2003, the FDA determined that it would allow a qualified health claim stating that consuming phosphatidylserine may reduce the risk of dementia in the elderly. However, the FDA has determined that there is very little scientific evidence supporting this claim (102363).
• Depression. It is unclear if oral phosphatidylserine is beneficial for depression. Details: One very small clinical study in elderly adults with depression shows that taking phosphatidylserine 300 mg daily for 30 days modestly improves depression scores when compared to baseline (7113).
• Exercise-induced muscle soreness. It is unclear if oral phosphatidylserine is beneficial for exercise-induced muscle soreness. Details: One small clinical study in athletes shows that taking soybean-derived phosphatidylserine 800 mg daily for 2 weeks during periods of over-training reduces muscle soreness post-exercise when compared with those not taking phosphatidylserine (2264). More evidence is needed to rate phosphatidylserine 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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POSSIBLY SAFE ...when used orally and appropriately. Phosphatidylserine has been used with apparent safety at dose of up to 300 mg daily for up to 6 months (2255,2437,2438,2439,2440,2441,7118,15539,68855).

CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term (7117). Phosphatidylserine has been used with apparent safety in clinical research in doses of 200-300 mg daily for up to 4 months in children aged 4-18 years (7117,89498).

PREGNANCY AND LACTATION:
Insufficient reliable information available; 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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ANTICHOLINERGIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, phosphatidylserine might decrease the effectiveness anticholinergic drugs.  Details Phosphatidylserine is thought to increase acetylcholine levels (2437,8857,8858), which could theoretically interfere with the activity of anticholinergic agents.

CHOLINERGIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, phosphatidylserine might have additive effects with cholinergic drugs.  Details Phosphatidylserine is thought to increase acetylcholine levels (2437,8857,8858), which could theoretically lead to additive cholinergic effects when used with cholinergic drugs.

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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, phosphatidylserine is generally well tolerated.
Most Common Adverse Effects:
Orally: Flatulence, gastrointestinal upset, headache, insomnia, and nausea.

Gastrointestinal ...Orally, phosphatidylserine can cause gastrointestinal upset such as flatulence or nausea. Gastrointestinal upset can occur at doses of 200-300 mg/day (7116,7121,15539,68862,90711).

Neurologic/CNS ...Orally, phosphatidylserine can cause insomnia. Insomnia is more likely to occur with a higher dose of 600 mg (7121,68844). Headache has also been reported (90711).

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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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