Ingredients | Amount Per 6 Softgels |
---|---|
(as Pyridoxal 5-Phosphate)
(Vitamin B6 (Form: as Pyridoxal 5' Phosphate) )
|
7 mg |
(Schizochytrium sp.)
(DHA (Form: from Algal oil Genus: Schizochytrium Species: sp.) (Alt. Name: Docosahexaenoic Acid) )
|
150 mg |
60 mg | |
60 mg | |
PQQ
(Pyrroloquinoline Quinone)
(Pyrroloquinoline Quinone Disodium Salt)
|
5 mg |
Fish Gelatin, Vegetable Glycerin, MCT Oil, Natural Flavors, purified Water, Beeswax, Antioxidant Blend (Form: Ascorbyl Palmitate, Mixed Tocopherols), natural Red color PlantPart: fruit Note: vegetable, Rebaudioside A
Below is general information about the effectiveness of the known ingredients contained in the product Brain Focus Natural Berry Flavor. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Brain Focus Natural Berry Flavor. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY SAFE ...when docosahexaenoic acid (DHA)-enriched algal oil is used orally and appropriately. Specific algal oils (DHASCO and DHASCO-S, Martek Biosciences Corp) have been safely used in clinical research at doses of 1.5-15 grams daily for 4-15 weeks (48254). One of these oils (DHASCO, Martek Biosciences Corp) has also been safely used in doses of about 1.5-9 grams, providing DHA 30 mg/kg, daily for up to 4 years (90684). These algal oils provide approximately 35% to 40% DHA, small amounts of saturated and monounsaturated fatty acids, and insignificant amounts of eicosapentaenoic acid (EPA) (48254). However, there is some concern that high intake of omega-3 fatty acids in algal oil might increase the risk of bleeding. For this reason, the US Food and Drug Administration (FDA) recommends that consumers limit intake of DHA plus EPA to 3 grams daily, with no more than 2 grams daily from a dietary supplement (95739).
POSSIBLY SAFE ...when eicosapentaenoic acid (EPA)-enriched algal oil is used orally and appropriately. A specific algal oil supplement (Almega PL) providing EPA 250 mg daily has been used with apparent safety for up to 12 weeks (103314). However, there is some concern that high intake of omega-3 fatty acids in algal oil might increase the risk of bleeding. For this reason, the US Food and Drug Administration (FDA) recommends that consumers limit intake of DHA plus EPA to 3 grams daily, with no more than 2 grams daily from a dietary supplement (95739).
POSSIBLY UNSAFE ...when used orally in high doses. Algal oil contains docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA). There is some concern that taking more than 3 grams of EPA plus DHA daily might decrease platelet aggregation and increase the risk of bleeding (1313). The US Food and Drug Administration (FDA) recommends that consumers limit intake of DHA plus EPA to 3 grams daily, with no more than 2 grams daily from a dietary supplement (95739).
CHILDREN: LIKELY SAFE
when used orally and appropriately.
Docosahexaenoic acid (DHA)-enriched algal oil has been safely used as a source of DHA in some infant formulas since 2002 (5941,48084,48095,48343,98548). One specific type of algal oil (DHASCO) is generally recognized as safe (GRAS) for use in infant formula when combined with a fungal-derived arachidonic acid oil (ARASCO) (48176). In children 7 years and older, this same algal oil (DHASCO) providing DHA 30 mg/kg daily has been used safely for up to 4 years (90684). Algal oil 1-2.4 grams providing 0.4-1 grams of DHA daily has also been safely used in children ages 4 years and older for up to 1 year (11333,90665,104560). There is insufficient reliable information available about the safety of eicosapentaenoic acid (EPA)-enriched algal oils in children.
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately.
Docosahexaenoic acid (DHA)-enriched algal oil is commonly included as a component of prenatal vitamins. Algal oil providing DHA 400-600 mg daily during pregnancy has been used with apparent safety in most clinical research (90672,90694). When taken as a prenatal supplement, DHA-enriched algal oil increases DHA levels in breast milk (90685). Taking DHA-enriched algal oil during lactation also increases levels of DHA in breast milk (109214,110362). One study found that using DHA-enriched algal oil during lactation increased the risk of bronchopulmonary dysplasia in breastfed infants born at less than 29 weeks gestational age; however, it is unclear if this was due to DHA or various confounding factors (104559). The tolerable upper intake level of DHA during pregnancy or lactation has not been established. Most experts recommend an intake of DHA 200-300 mg daily during pregnancy and lactation. While it is typically advised that this need be met by consuming 8-12 ounces of seafood weekly during pregnancy and 4-8 ounces weekly during lactation, individuals with nutrient deficiency or those following a vegan diet may meet this need with supplementation, including algal oil (95740,95741).
There is insufficient reliable information available about the safety of eicosapentaenoic acid (EPA)-enriched algal oils during pregnancy or lactation.
POSSIBLY SAFE ...when used orally and appropriately. Large doses up to 30 grams per day for 6 weeks (5223) and smaller doses of up to 6 grams daily for up to 24 months have been well tolerated (68839,68843,105728). ...when used subcutaneously and appropriately, short-term. Some research suggests that subcutaneous injections of 0.2 mL to 5 mL of a 5% phosphatidylcholine solution do not cause significant serious adverse effects when doses are administered up to five times and spaced apart by 2-4 weeks (15621,15623,15624,15625). ...when used topically as an emulsion also containing niacinamide for up to 12 weeks (93388).
PREGNANCY: POSSIBLY SAFE
when used orally from 18 weeks of gestation at doses of up to 5 grams daily (93386)
LACTATION:
Insufficient reliable information available; avoid using.
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.
LIKELY SAFE ...when used orally and appropriately in doses that do not exceed the tolerable upper intake level (UL) of 100 mg daily for adults (15). ...when used parenterally and appropriately. Injectable vitamin B6 (pyridoxine) is an FDA-approved prescription product (15).
POSSIBLY SAFE ...when used orally and appropriately in doses of 101-200 mg daily (6243,8558).
POSSIBLY UNSAFE ...when used orally in doses at or above 500 mg daily. High doses, especially those exceeding 1000 mg daily or total doses of 1000 grams or more, pose the most risk. However, neuropathy can occur with lower daily or total doses (6243,8195). ...when used intramuscularly in high doses and frequency due to potential for rhabdomyolysis (90795).
CHILDREN: LIKELY SAFE
when used orally and appropriately (3094).
CHILDREN: POSSIBLY SAFE
when used orally and appropriately in amounts exceeding the recommended dietary allowance (5049,8579,107124,107125,107135).
CHILDREN: POSSIBLY UNSAFE
when used orally in excessive doses, long-term (3094).
PREGNANCY: LIKELY SAFE
when used orally and appropriately.
A special sustained-release product providing vitamin B6 (pyridoxine) 75 mg daily is FDA-approved for use in pregnancy. Vitamin B6 (pyridoxine) is also considered a first-line treatment for nausea and vomiting in pregnancy by the American College of Obstetrics and Gynecology (111601). However, it should not be used long-term or without medical supervision and close monitoring.
PREGNANCY: POSSIBLY UNSAFE
when used orally in excessive doses.
There is some concern that high-dose maternal vitamin B6 (pyridoxine) can cause neonatal seizures (4609,6397,8197).
LACTATION: LIKELY SAFE
when used orally in doses not exceeding the recommended dietary allowance (RDA) (3094).
The RDA in lactating women is 2 mg daily. There is insufficient reliable information available about the safety of vitamin B6 when used in higher doses in breast-feeding women.
Below is general information about the interactions of the known ingredients contained in the product Brain Focus Natural Berry Flavor. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, algal oil may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
Details
The risk of interaction is highest for algal oil containing high amounts (> 2 grams daily) of eicosapentaenoic acid (EPA), or EPA and docosahexaenoic acid (DHA). High doses of EPA or oils containing EPA and DHA can reduce platelet aggregation in humans (8671,8679,8696,9930,13769,21223,21224,66258). However, most algal oil contains very little EPA and larger amounts of DHA. While some conflicting evidence exist, most research shows that DHA alone does not affect blood clotting (9930,11112,11113,48020).
|
Theoretically, taking algal oil with antidiabetes drugs might interfere with the effects of antidiabetes drugs and reduce their effects.
Details
Most algal oil contains docosahexaenoic acid (DHA). Clinical research in people with type 2 diabetes, including those taking antidiabetes drugs, shows that taking DHA 4 grams daily for 6 weeks increases fasting blood glucose levels by about 18 mg/dL when compared with taking olive oil (10321).
|
Theoretically, taking algal oil with antihypertensive drugs might increase the risk of hypotension.
Details
Algal oil usually contains docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA). There is evidence that fish oil, which also contains DHA and EPA, can modestly lower blood pressure and might have additive effects in patients treated with antihypertensive drugs (1001,1020,1030,1033,47944,48013,48020,48163).
|
Theoretically, phosphatidylserine might decrease the effectiveness anticholinergic drugs.
Details
|
Theoretically, phosphatidylserine might have additive effects with cholinergic drugs.
Details
|
Theoretically, vitamin B6 might increase the photosensitivity caused by amiodarone.
Details
|
Theoretically, vitamin B6 may have additive effects when used with antihypertensive drugs.
Details
Research in hypertensive rats shows that vitamin B6 can decrease systolic blood pressure (30859,82959,83093). Similarly, clinical research in patients with hypertension shows that taking high doses of vitamin B6 may reduce systolic and diastolic blood pressure, possibly by reducing plasma levels of epinephrine and norepinephrine (83091).
|
Vitamin B6 may increase the metabolism of levodopa when taken alone, but not when taken in conjunction with carbidopa.
Details
Vitamin B6 (pyridoxine) enhances the metabolism of levodopa, reducing its clinical effects. However, this interaction does not occur when carbidopa is used concurrently with levodopa (Sinemet). Therefore, it is not likely to be a problem in most people (3046).
|
High doses of vitamin B6 may reduce the levels and clinical effects of phenobarbital.
Details
|
High doses of vitamin B6 may reduce the levels and clinical effects of phenytoin.
Details
|
Below is general information about the adverse effects of the known ingredients contained in the product Brain Focus Natural Berry Flavor. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...Orally, algal oil is generally well tolerated.
Most Common Adverse Effects:
Orally: Fishy burps and gastrointestinal symptoms.
Cardiovascular ...Orally, docosahexaenoic acid (DHA)-enriched algal oil 68 grams daily) can modestly increase low-density lipoprotein (LDL) cholesterol levels by about 8% in patients without coronary heart disease. This increase in LDL cholesterol is similar to that observed for patients taking purified DHA 4 grams daily (90669).
Dermatologic ...Orally, one parent of a pediatric patient treated with algal oil providing docosahexaenoic acid (DHA) 600 mg daily for 16 weeks reported increased hair loss beginning 6 weeks after completion of supplementation (90699). It is unclear if this adverse effect is specifically related to algal oil intake. Algal oil may theoretically cause itching, rash, or warmth in the hands due to its constituents DHA and/or eicosapentaenoic acid (EPA) (15497,48217); however, while these adverse effects have been reported with other sources of DHA and EPA, they have not been reported specifically for patients taking algal oil.
Gastrointestinal ...Orally, fishy burps and mild nonspecific gastrointestinal symptoms have been reported in clinical research for participants taking algal oil providing docosahexaenoic acid (DHA) 600 mg daily for 2 weeks (48220). Algal oil may theoretically cause other adverse events including nausea, vomiting, flatulence, and loose stools due to its DHA and eicosapentaenoic acid (EPA) constituents (1009,1313,8699,10007,10869,11333,15497,103314); however, these adverse effects have not been reported specifically for patients taking algal oil.
Genitourinary ...Orally, algal oil may theoretically cause decreased libido due to its constituent docosahexaenoic acid (DHA). In one clinical study, one patient taking DHA 1, 2, or 4 grams daily (specific dose unclear) reported decreased libido (48217); however, this adverse effect has not been reported specifically for patients taking algal oil.
Hematologic ...Orally, algal oil might cause nose bleeds, but this is uncommon. Onset of severe nose bleeds has been reported in one clinical study in one child who took algal oil providing docosahexaenoic acid (DHA) 600 mg daily (98542). Some algal oil may theoretically decrease blood coagulation and increase the risk of bleeding in some patients due to its fatty acid constituents (1009,1313,8699,10007,15497); however, the potential risk might depend on the ratio of DHA and eicosapentaenoic acid (EPA) in the algal oil. Most clinical research shows that DHA alone does not affect blood clotting (11112,11113,48020). Therefore, algal oils containing high amounts of DHA and negligible amounts of EPA seem unlikely to increase the risk. However, there is evidence that taking high doses of oils providing EPA and DHA might decrease blood coagulation and increase the risk of bleeding (1313). The US Food and Drug Administration (FDA) recommends that consumers limit intake of EPA plus DHA to 3 grams daily, with no more than 2 grams daily from a dietary supplement (95739). While these adverse effects have not been reported specifically for patients taking algal oil, patients should limit intake of algal oil to daily doses providing no more than 2 grams of EPA and DHA.
Musculoskeletal ...Orally, algal oil may theoretically cause joint pain due to its constituent, eicosapentaenoic acid (EPA), although results are conflicting. In one clinical study, a higher percentage of patients treated with EPA ethyl ester 2 or 4 grams daily experienced arthralgia compared to placebo (3.4% and 1.7% vs 0.4%, respectively) (91409). However, in another study, slightly fewer patients taking EPA ethyl ester 1.8 grams daily experienced joint, lumbar, or muscle pain compared to placebo (1.6% vs 2.0%, respectively) (15497). These adverse effects have not been reported specifically for patients taking algal oil.
Neurologic/CNS ...Orally, algal oil may theoretically cause insomnia or light-headedness/dizziness due to its constituent docosahexaenoic acid (DHA). In one clinical study, three adult patients reported light-headedness or dizziness, and one patient reported insomnia, when treated with DHA 2 grams daily. It is unclear if these events are treatment related, as one patient in the placebo group also reported insomnia (10869). These adverse effects have not been reported specifically for patients taking algal oil.
Oncologic ...Orally, algal oil may theoretically increase the risk of prostate cancer due to its constituent docosahexaenoic acid (DHA); however, further research is needed to clarify this finding. An analysis of data from observational studies found that higher DHA intake is associated with a non-linear increased risk of prostate cancer (90677). However, it is unclear if supplemental DHA intake is associated with an increased risk of prostate cancer, and this association has not been reported specifically for patients taking algal oil.
General ...Phosphatidylcholine is generally well tolerated when used orally, subcutaneously, or topically. Orally, bloating, diarrhea, altered taste, nausea, vomiting, sweating, and itching have been reported with phosphatidylcholine (5229,63244,68843,93389,93390,105728). Ingesting large amounts of around 30 grams daily is associated with a higher incidence of gastrointestinal upset and diarrhea (5223). Subcutaneously, pain, burning, itching, tenderness to touch, bruising, edema, nodules, hematoma, and erythema at the injection site have been reported with phosphatidylcholine (1562,15623,15624,15625,15626,15627,15628). High subcutaneous doses exceeding 1.2 grams of phosphatidylcholine can cause nausea and abdominal pain in some people (15624). Injecting phosphatidylcholine directly into a lipoma can result in a significant inflammatory response and undesirable fibrotic tissues changes (15622).
Dermatologic ...When taken orally, phosphatidylcholine may increase sweating (5229) and itching (63244). When given subcutaneously, phosphatidylcholine can cause pain, burning, itching, tenderness to touch, bruising, edema, and erythema at the injection site. The pain, itching and erythema usually resolve within 2 days of treatment; however localized tenderness can last longer (15623,15624,15626,15627,15628). Edema and bruising usually resolve within 10 days of treatment (15621,15623,15625). Some people can also develop nodules or hematoma at the injection site. This usually resolves within 30 days (15627).
Gastrointestinal ...Ingesting large amounts of phosphatidylcholine (30 grams per day) can cause gastrointestinal upset and diarrhea (5223). However, bloating, diarrhea, altered taste, nausea, and vomiting have been reported with smaller doses (63244,68843,93389,93390,105728). Although moderate subcutaneous doses do not usually cause systemic side effects, high doses exceeding 1.2 grams of phosphatidylcholine can cause nausea and abdominal pain in some people (15624).
Musculoskeletal ...Injecting phosphatidylcholine directly into a lipoma can result in a significant inflammatory response and undesirable fibrotic tissue changes (15622).
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).
General
...Orally or by injection, vitamin B6 is well tolerated in doses less than 100 mg daily.
Most Common Adverse Effects:
Orally or by injection: Abdominal pain, allergic reactions, headache, heartburn, loss of appetite, nausea, somnolence, vomiting.
Serious Adverse Effects (Rare):
Orally or by injection: Sensory neuropathy (high doses).
Dermatologic ...Orally, vitamin B6 (pyridoxine) has been linked to reports of skin and other allergic reactions and photosensitivity (8195,9479,90375). High-dose vitamin B6 (80 mg daily as pyridoxine) and vitamin B12 (20 mcg daily) have been associated with cases of rosacea fulminans characterized by intense erythema with nodules, papules, and pustules. Symptoms may persist for up to 4 months after the supplement is stopped, and may require treatment with systemic corticosteroids and topical therapy (10998).
Gastrointestinal ...Orally or by injection, vitamin B6 (pyridoxine) can cause nausea, vomiting, heartburn, abdominal pain, mild diarrhea, and loss of appetite (8195,9479,16306,83064,83103,107124,107127,107135). In a clinical trial, one patient experienced infectious gastroenteritis that was deemed possibly related to taking vitamin B6 (pyridoxine) orally up to 20 mg/kg daily (90796). One small case-control study has raised concern that long-term dietary vitamin B6 intake in amounts ranging from 3.56-6.59 mg daily can increase the risk of ulcerative colitis (3350).
Hematologic ...Orally or by injection, vitamin B6 (pyridoxine) can cause decreased serum folic acid concentrations (8195,9479). One case of persistent bleeding of unknown origin has been reported in a clinical trial for a patient who used vitamin B6 (pyridoxine) 100 mg twice daily on days 16 to 35 of the menstrual cycle (83103). It is unclear if this effect was due to vitamin B6 intake.
Musculoskeletal ...Orally or by injection, vitamin B6 (pyridoxine) can cause breast soreness or enlargement (8195).
Neurologic/CNS ...Orally or by injection, vitamin B6 (pyridoxine) can cause headache, paresthesia, and somnolence (8195,9479,16306). Vitamin B6 (pyridoxine) can also cause sensory neuropathy, which is related to daily dose and duration of intake. Doses exceeding 1000 mg daily or total doses of 1000 grams or more pose the most risk, although neuropathy can occur with lower daily or total doses as well (8195). The mechanism of the neurotoxicity is unknown, but is thought to occur when the liver's capacity to phosphorylate pyridoxine via the active coenzyme pyridoxal phosphate is exceeded (8204). Some researchers recommend taking vitamin B6 as pyridoxal phosphate to avoid pyridoxine neuropathy, but its safety is unknown (8204). Vitamin B6 (pyridoxine) neuropathy is characterized by numbness and impairment of the sense of position and vibration of the distal limbs, and a gradual progressive sensory ataxia (8196,10439). The syndrome is usually reversible with discontinuation of pyridoxine at the first appearance of neurologic symptoms. Residual symptoms have been reported in patients taking more than 2 grams daily for extended periods (8195,8196). Tell patients daily doses of 100 mg or less are unlikely to cause problems (3094).
Oncologic ...In females, population research has found that a median intake of vitamin B6 1. 63 mg daily is associated with a 3.6-fold increased risk of rectal cancer when compared with a median intake of 1.05 mg daily (83024). A post-hoc subgroup analysis of results from clinical research in adults with a history of recent stroke or ischemic attack suggests that taking folic acid, vitamin B12, and vitamin B6 does not increase cancer risk overall, although it was associated with an increased risk of cancer in patients who also had diabetes (90378). Also, in patients with nasopharyngeal carcinoma, population research has found that consuming at least 8.6 mg daily of supplemental vitamin B6 during treatment was associated with a lower overall survival rate over 5 years, as well as a reduced progression-free survival, when compared with non-users and those with intakes of up to 8.6 mg daily (107134).