| Ingredients | Amount Per Serving |
|---|---|
|
Proprietary Blend
|
1000 mg |
|
(CLA)
|
|
|
(18:3n-6, GLA)
|
|
|
(ALA, C18:3n-3)
|
|
|
(C20:5n-3, EPA)
|
|
|
(C22:6n-3, DHA)
|
|
|
Omega 3-6-9 Blend
|
Gelatin, Glycerin, purified Water, D-Alpha-Tocopherol
Below is general information about the effectiveness of the known ingredients contained in the product Omega 3-6-9 Muscle Gels. 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
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Omega 3-6-9 Muscle Gels. 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 used orally in amounts typically found in foods (7141,7142,7144). There is insufficient reliable information available about the safety of alpha-linolenic acid when used in larger, medicinal amounts.
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts typically found in foods (7141,7142,7145).
There is insufficient reliable information available about the safety of alpha-linolenic acid during pregnancy and lactation when used in larger, medicinal amounts; avoid using.
LIKELY SAFE ...when used orally in amounts found in foods. CLA occurs naturally in milk fat, beef, and the meat of other ruminant animals (5924,5925,5932,5933).
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts of up to 6. 8 grams daily, short-term (2819,2821,3153,4947,10410,11327,111056).
CHILDREN: LIKELY SAFE
when used orally in amounts found in foods.
CLA occurs naturally in milk fat, beef, and the meat of other ruminant animals (5924,5925,5932,5933).
CHILDREN: POSSIBLY SAFE
when used orally and appropriately in medicinal amounts.
Some evidence suggests that CLA 3 grams daily can be taken safely for up to 7 months (45713).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts found in foods (5924,5932,5933).
There is insufficient reliable information available about the safety of CLA when used in medicinal amounts during pregnancy or lactation; avoid using.
LIKELY SAFE ...when used orally and appropriately. DHA has been used safely in studies lasting up to 4 years (1016,1043,6413,10321,10869,11333,90684). Fish oil supplements containing DHA have also been safely used in studies lasting up to 7 years (1016). While doses of DHA up to 4 grams orally daily have been used safely in some clinical research (6143), there is some concern that high intake of omega-3 fatty acids such as DHA might increase the risk of bleeding. For this reason, the US Food and Drug Administration (FDA) recommends that consumers limit intake of DHA plus eicosapentaenoic acid (EPA), another omega-3 fatty acid also found in fish oil, to 3 grams daily, with no more than 2 grams daily from a dietary supplement (95739).
POSSIBLY SAFE ...when used intravenously and appropriately, in combination with eicosapentaenoic acid (EPA), short-term. Daily infusions with an omega-3 fatty acid-based lipid emulsion (Omegavenous 10%, Fresenius Aktiengesellschaft) providing 4.2 grams/day of DHA and EPA has been used safely for 14 days (1004).
POSSIBLY UNSAFE ...when used orally in high doses. Doses greater than 3 grams 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 eicosapentaenoic acid (EPA), another omega-3 fatty acid, to 3 grams daily, with no more than 2 grams daily from a dietary supplement (95739).
CHILDREN: LIKELY SAFE
when used orally and appropriately.
DHA is a component of some infant formula (424,1045,5708,5941,7599,14403,15003,15495,17735,48088)(48194,48266,48343,90665,90713,90716,110357). In children 7 years and older, DHA 30 mg/kg daily has been used safely for up to 4 years (90684). Also, DHA 0.4-1 grams daily has been safely used in children ages 4 years and older for up to 1 year (11333,90665,100940,104560).
CHILDREN: POSSIBLY UNSAFE
when used orally in preterm infants born less than 29 weeks gestation.
Although not all findings agree (110356,110359), supplementation with an enteral emulsion containing DHA 40 mg/kg to 60 mg/kg daily might increase the risk of developing or worsening bronchopulmonary dysplasia compared to control emulsion (96523,110359).
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately.
An intake of DHA 650 mg daily from food and/or supplements during pregnancy seems to be required to prevent a reduction in DHA status before delivery (110329). DHA is commonly used during pregnancy and lactation and is a component of some prenatal supplements. DHA is a normal component of breast milk, with higher levels in breast milk following term vs. preterm pregnancies (14393,14394,14396,14400,14403,14397,20000,47977,47994,48095)(90672,90718,110355). When taken as a prenatal supplement, DHA increases DHA levels in breast milk (90685). Doses of DHA ranging from 300-600 mg daily beginning during the first trimester of pregnancy have been used safely in clinical research (90672,90676,90687,90694). When taken during lactation, DHA increases DHA levels in breast milk (109214,110362). When initiated within 72 hours of delivery of a very preterm infant, taking DHA 1.2 grams daily increases DHA levels in breast milk within 14 days (109214). One study found that DHA supplementation during lactation increased the risk of bronchopulmonary dysplasia in breast-feeding infants born less than 29 weeks gestational age (104559); however, it is unclear if this was due to DHA or various confounding factors. The tolerable upper intake level of DHA during pregnancy or lactation has not been established; most experts recommend DHA 200-300 mg daily. While it is typically advised that this need is met by consuming 8-12 ounces of seafood weekly during pregnancy and 4-8 ounces weekly during lactation, those with nutrient deficiency or those following a vegan diet may meet this need with supplementation (95740,95741).
LIKELY SAFE ...when fish oil or prescription EPA is used orally and appropriately as a source of EPA. Fish oil containing EPA has been used safely for up to 7 years (1016,7819,15497). While doses of prescription EPA (Vascepa, formerly ARM101, Amarin) have been used safely at doses up to 4 grams daily (91409,91410,95715,99136), there is some concern that high intake of omega-3 fatty acids such as EPA might increase the risk of bleeding. For this reason, the US Food and Drug Administration (FDA) recommends that consumers limit intake of EPA plus docosahexaenoic acid (DHA), another omega-3 fatty acid also found in fish oil, to 3 grams daily, with no more than 2 grams daily from a dietary supplement (95739).
POSSIBLY SAFE ...when algal oil is used orally and appropriately as a source of EPA. A specific algal oil supplement (Almega PL) providing EPA 250 mg daily has been used with apparent safety for up to 12 weeks (103314). ...when used intravenously under the guidance of a healthcare professional. Fish oil or omega-3 fatty acid lipid emulsions containing EPA, administered intravenously for 1-4 weeks, have been safely used (1004,66042,66421,89323).
POSSIBLY UNSAFE ...when used orally in high doses. Doses greater than 3 grams daily 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, another omega-3 fatty acid, to 3 grams daily, with no more than 2 grams daily from a dietary supplement (95739).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Omega 3-6-9 Muscle Gels. 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, CLA may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
 Details
Some clinical evidence suggests that intake of CLA reduces platelet aggregation by approximately 10% (45607). The clinical significance of this effect is unclear.
|
Theoretically, taking CLA with antihypertensive drugs might increase the risk of hypotension.
Details
|
Theoretically, taking black seed with ramipril might increase the risk of hypotension.
Details
Some clinical research shows that CLA enhances the blood pressure-lowering effects of ramipril (45569).
|
Theoretically, DHA may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
Details
Although some clinical evidence suggests that DHA might reduce collagen-stimulated platelet aggregation and thromboxane release, most clinical evidence suggests that DHA alone does not affect blood clotting (11112,11113,48020). However, theoretically, when given in combination with EPA as fish oil, concomitant use with anticoagulant or antiplatelet drugs (including aspirin) might increase risk of bleeding.
|
Theoretically, taking DHA with antidiabetes drugs might reduce the effects of these medications.
Details
In people with type 2 diabetes, including those taking oral hypoglycemic medications, DHA seems to increase fasting blood glucose levels (10321).
|
Theoretically, taking DHA with antihypertensive drugs might increase the risk of hypotension.
Details
|
Theoretically, EPA may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
Details
In human research, taking EPA has been shown to inhibit platelet aggregation (9930).
|
Theoretically, taking EPA with antihypertensive drugs might increase the risk of hypotension.
Details
|
Theoretically, GLA might increase the risk of bleeding when taken with anticoagulant or antiplatelet rugs.
Details
Animal and human research suggests that GLA reduces platelet aggregation (1979).
|
Below is general information about the adverse effects of the known ingredients contained in the product Omega 3-6-9 Muscle Gels. 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, alpha-linolenic acid from dietary sources is well tolerated when used in the diet as a replacement for other sources of fat, such as saturated fats.
Serious Adverse Effects (Rare):
Orally: There is some concern that high dietary intake of alpha-linolenic acid might increase the risk for prostate cancer, although research is conflicting.
Oncologic ...Epidemiologic research suggests that high dietary intake of alpha-linolenic acid might increase risk for prostate cancer (1337,2558,7823,7147,12978). Other research suggests high intake or serum levels of alpha-linolenic acid does not increase the overall risk of prostate cancer (12961,15736); however, it might increase the risk of advanced prostate cancer (12961). Association with prostate cancer appears to depend on the sources of alpha-linolenic acid. Dairy and meat sources has been positively associated with prostate cancer, whereas plant sources, such as flaxseed, don't seem to affect prostate cancer risk (12909). According to a clinical trial, intake of alpha-linolenic acid does not appear to increase levels of prostate specific antigen (PSA) (91402). Also, longer-chain omega-3 fatty acids in fish oils are associated with a decreased risk of total and advanced prostate cancer (12961).
Other ...Alpha-linolenic acid is a type of fat, containing 9 kilocalories/gram, and may result in weight gain if consumed in excess. Patients should be advised that it's best to substitute alpha-linolenic acid in the diet for other sources of fat, such as saturated fats.
General
...Orally, CLA is well tolerated when found in foods.
When taken in medicinal amounts, CLA seems to be well tolerated.
Most Common Adverse Effects:
Orally: Diarrhea, dyspepsia, flatulence, loose stools, and nausea.
Serious Adverse Effects (Rare) :
Orally: Cases of hepatotoxicity have been reported.
Cardiovascular
...Some preliminary clinical research suggests that the t10,c12 isomer of CLA can decrease high-density lipoprotein (HDL) cholesterol levels (2821).
This isomer of CLA, as well as a mixture of CLA isomers, seems to increase plasma triglyceride levels, the ratio of low-density lipoprotein (LDL) cholesterol to HDL cholesterol, and the ratio of total cholesterol to HDL cholesterol (45148,45468), although not all research has identified these effects (107475).
A meta-analysis of 6 randomized, controlled trials shows that administration of CLA in individuals who are overweight or obese significantly increases lipoprotein (a) levels, a value associated with increased risk of cardiovascular disease. Subgroup analyses suggest this increase is more prominent in trials that are longer than 6 months in duration and with CLA doses of at least 3.5 grams daily (107475).
Endocrine ...Orally, CLA has been shown to increase insulin resistance and glucose concentrations, as well as decrease insulin sensitivity in some patients, including obese individuals or patients with type 2 diabetes (2821,13026,45145,45152,45513). Some evidence suggests that this effect is isomer-specific and occurs with only the t10,c12 isomer (2821,13026), while other evidence shows that decreased insulin sensitivity may also occur with the c9,t11 isomer or with a 50:50 mixture of c9,t11 and t10,c12 isomers (45145,45152).
Gastrointestinal ...Orally, the most common adverse effect reported with CLA is gastrointestinal upset including diarrhea, constipation, nausea, loose stools, dyspepsia, bloating, and flatulence (3153,4947,45280,45705,45730,111056). Esophageal irritation was reported in one patient who bit open and swallowed a capsule containing CLA (45577).
Hepatic ...Orally, clinical research shows that CLA 3 grams daily for 12 weeks does not affect liver outcome measures (105809). However, there are at least two case reports of hepatotoxicity. Asthenia, jaundice, and pruritus were reported in a 46-year-old female who consumed CLA for two weeks. Abnormal liver enzyme levels returned to normal following discontinuation of CLA supplementation (45483). Hepatotoxicity, presenting as fulminant hepatitis and characterized by anorexia, nausea, jaundice, choluria, and hepatic encephalopathy requiring liver transplantation has also been reported in a 63-year-old female taking a CLA-containing weight-loss supplement for one month (91589).
Musculoskeletal ...Orally, CLA has been reported to cause back ache in one individual in one clinical trial (45787).
Neurologic/CNS ...Orally, CLA may cause headache or fatigue (3153,45787). In one case report, a 50-year-old female presented with headache and subarachnoid hemorrhage due to reversible cerebral vasoconstriction syndrome (RCVS) after taking a combination product containing green tea, L-carnitine, and CLA for one week. At 28 days after discontinuation of the combination product and surgery, angiography showed complete regression of vascular restrictions (97007). It is unclear if this adverse effect was due to CLA, another ingredient in the product, or a combination of ingredients.
Other ...Orally, CLA has been reported to cause halitosis in one patient in one clinical trial (45839).
General
...Orally, DHA is generally well-tolerated when used in doses up to 3 grams daily.
Intravenously, DHA seems to be well tolerated.
Most Common Adverse Effects:
Orally: Belching, fishy aftertaste, loose stools, and nausea.
Serious Adverse Effects (Rare):
Orally: Some case reports raise concerns about increased risk of bleeding with high doses of fish oil containing DHA.
Cardiovascular ...Orally, DHA might increase low-density lipoprotein (LDL) cholesterol levels. However, this appears to be primarily due to increases in the large buoyant type of LDL particles. The small, dense type of LDL particles are reduced (6143,48013,48078,48083,48174,48338).
Dermatologic ...Orally, DHA has been associated with one report of rash and one report of warmth on hands in one clinical study (48217). In another clinical study, two patients taking DHA 400 mg daily reported acne (11333). In another clinical study, one parent of a pediatric patient treated with DHA 600 mg daily reported increased hair loss beginning 6 weeks after completion of supplementation (90699). It is unclear if this adverse effect is specifically related to DHA intake.
Gastrointestinal
...Orally, DHA may cause gastrointestinal upset, fishy aftertaste, belching, flatulence, heartburn, loose stools, anorexia, and dry mouth (10869,11333,48217,109218).
There is also some evidence that increased serum levels of DHA might be associated with an increased risk for atrophic gastritis associated with Helicobacter pylori infection, but further research is needed to clarify this finding (8709).
For fish oils containing EPA and DHA, side effects can include fishy taste, belching, nausea, and loose stools (1009,1313,8699,10007). Three people with pre-existing familial adenomatous polyposis were diagnosed with malignant lesions during the course of long-term fish oil use (999).
Genitourinary ...Orally, one patient in one clinical study who was taking DHA 1, 2, or 4 grams daily (specific dose unclear) reported decreased libido (48217).
Hematologic ...Orally, DHA 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 DHA 600 mg daily (98542). Although most clinical research shows that DHA does not affect blood clotting when taken alone (11112,11113,48020), there is some concern that taking high doses of oils providing DHA along with eicosapentaenoic acid (EPA) 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).
Neurologic/CNS ...Orally, DHA may cause dizziness, headache, insomnia, fatigue, and anxiety (10869,11333,48217). In one clinical study, one parent of a pediatric patient treated with DHA 600 mg daily reported increased disruptive behavior in the child (90699).
Ocular/Otic ...Orally, DHA may cause watery eyes but results are inconsistent. In one clinical study, five of 167 infants fed formula containing 0.32% or 0.64% DHA experienced watery eyes. However, none of the infants fed formula containing 0.96% DHA experienced watery eyes (90670). In one clinical study, one patient taking DHA 400 mg daily experienced an ear infection. It is unclear if this event was related to DHA supplementation.
Oncologic ...Orally, DHA may increase the risk of prostate cancer, but additional research is needed to clarify this finding. A meta-analysis of data from observational studies found that higher dietary intake of DHA is associated with a non-linear increased risk of prostate cancer (90677). It is unclear if supplemental DHA intake is associated with increased risk of prostate cancer.
Pulmonary/Respiratory ...Orally, worsened asthma symptoms were reported by one parent of one patient with asthma taking DHA 600 mg daily (90699).
General
...Orally, prescription EPA or EPA derived from fish oil is generally well tolerated in doses of up to 3 grams daily.
Agal oil providing EPA seems to be well tolerated. Doses of EPA greater than 3 grams daily are possibly unsafe.
Intravenously, fish oil or omega-3 fatty acid lipid emulsions containing EPA seem to be well tolerated.
Most Common Adverse Effects:
Orally: Belching, diarrhea, epigastric discomfort, fishy aftertaste, and nausea.
Serious Adverse Effects (Rare):
Orally: Some case reports raise concerns about increased risk of bleeding with high doses.
Cardiovascular ...Orally, taking the prescription ethyl-EPA product (Vascepa, Amarin) 4 grams daily has been linked to a 1% greater risk of atrial fibrillation or atrial flutter that required hospitalization when compared with placebo (101286).
Dermatologic ...Orally, reported side effects of EPA have included skin rash and itching (15497).
Gastrointestinal ...Orally, reported side effects of EPA have included nausea, diarrhea, and epigastric discomfort (15497,103314,110365,110366). For fish oils containing EPA and docosahexaenoic acid, side effects can include fishy taste, belching, nausea, and loose stools (10007).
Hematologic ...Orally, reported side effects of EPA, as well as fish oils containing EPA and docosahexaenoic acid (DHA), have included nosebleed (10007,15497). There is some concern that taking high doses of oils providing EPA along with DHA might decrease blood coagulation and increase the risk of bleeding (1313). To reduce this risk, 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). The prescription ethyl-EPA product (Vascepa, Amarin) 4 grams daily has been linked to bleeding in 12% of patients, compared with 10% in the placebo group. Serious bleeding occurred in 3% of the Vascepa group compared to 2% in the placebo group (101286).
Immunologic ...There is preliminary evidence that the EPA in fish oil decreases natural killer (NK) cell activity. Due to this effect, there is concern that increased intake of EPA might have some adverse immunologic effects and possibly increase the risk for viral infections and some cancers (8718).
Musculoskeletal ...Orally, EPA may cause musculoskeletal pain in some patients, although results from clinical research are conflicting. In one clinical study, a higher percentage of patients treated with ethyl-EPA 2 or 4 grams daily experienced joint pain compared to placebo (3.4% and 1.7% vs 0.4%, respectively) (91409). However, in another study, slightly fewer patients taking ethyl-EPA 1.8 grams daily experienced joint, lumbar, or muscle pain compared to placebo (1.6% vs 2.0%, respectively) (15497).
Oncologic ...Three people with pre-existing familial adenomatous polyposis have been diagnosed with malignant lesions during the course of long-term high-docosahexaenoic acid fish oil use (999); however, it is unclear if fish oil, or more specifically EPA, was the cause.
General
...Orally, GLA seems to be well tolerated.
Most Common Adverse Effects:
Orally: Mild gastrointestinal adverse effects, including belching, bloating, diarrhea, dyspepsia, flatulence, nausea, and vomiting.
Gastrointestinal ...Orally, GLA may cause mild gastrointestinal effects such as dyspepsia, nausea, bloating, vomiting, soft stools, diarrhea, flatulence, and belching (7701,7702,8926,107927).
Hematologic ...Orally, GLA might prolong bleeding time (1979).
