Omega-3 Supplements for Omega-3 Deficiency
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byCrawford Currie, MBBS
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Hofseth Biocare ASA
Disqualifiers: Fish allergies, Pregnant, Fish oil, Diabetes, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Omega-3 index is used as a proxy for an adequate intake of fish unsaturated fats in the diet. However, omega-3 supplements have not consistently shown the health benefits of eating fresh fish. This study will assess the change in omega-3 index and impact on markers of cardiometabolic health with two different supplements: a whole, unprocessed salmon oil and a standard, processed, concentrated oemga-3 oil. The markers to be studies included impact on inflammation and oxidative stress, cholesterol and markers of risk of diabetes. Change in sleep metrics will also be assessed.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Whole Salmon Oil for Omega-3 Deficiency?
Some studies suggest that omega-3 fatty acids, like those found in fish oil, can improve immune function and nutritional status in certain conditions, such as in HIV-infected patients. This implies that omega-3 supplements, including Whole Salmon Oil, might help improve omega-3 levels in people with deficiencies.
12345Is omega-3 supplementation safe for humans?
Omega-3 supplements, like fish oil, are generally considered safe for humans when taken in moderate amounts. Some possible side effects include nausea, diarrhea, and a 'fishy' taste, and there is a potential risk for increased bleeding, especially if taken with other blood-thinning medications. It's important to choose high-quality products to avoid contaminants and oxidation, which can affect safety.
678910How does Whole Salmon Oil treatment differ from other treatments for omega-3 deficiency?
Whole Salmon Oil is unique because it provides a natural source of omega-3 fatty acids, specifically EPA and DHA, which are essential for health. Unlike some other treatments, it comes from a whole food source, potentially offering a more balanced nutrient profile, including vitamins A, D, and E, which are often found in fish oils.
57111213Eligibility Criteria
Healthy, non-pregnant adults aged 40-80 with stable body weight for the past three months are eligible for this trial. It's designed to help those who may not be getting enough omega-3s from their diet.Inclusion Criteria
I am a healthy adult, not pregnant, aged 40-80, with a stable weight for the last 3 months.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either a whole, unprocessed salmon oil or a standard, processed omega-3 oil supplement for 14 weeks
14 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing the effects of two omega-3 supplements: whole salmon oil versus standard processed cod liver oil. Researchers will measure changes in omega-3 index and its impact on heart health, inflammation, oxidative stress, cholesterol levels, diabetes risk markers, and sleep quality.
2Treatment groups
Active Control
Group I: Omega-3 cod liver oil soft gel capsulesActive Control1 Intervention
A standard, processed, concentrated omega-3 supplement
Group II: CARDIO salmon oil soft gel capsulesActive Control1 Intervention
A minimally processed, whole salmon oil containing all the fatty acid fractions found in salmon
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
AlethiosMenlo Park, CA
Alethios, Inc.San Francisco, CA
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Who Is Running the Clinical Trial?
Hofseth Biocare ASALead Sponsor
References
Enhanced feeding and diminished postnatal growth failure in very-low-birth-weight infants. [2022]The aim of the present study was to determine whether an increased supply of energy, protein, essential fatty acids, and vitamin A reduces postnatal growth failure in very-low-birth-weight infants.
Intravenous fish oil in critically ill and surgical patients - Historical remarks and critical appraisal. [2019]The purpose of this review is to explain the historical and clinical background for intravenous fish oil administration, to evaluate its results by using a product specific metaanalysis, and to stimulate further research in the immune-modulatory potential of fish oil. Concerning the immune-modulatory effects of fatty acids, a study revealed that ω-3 as well as ω-6 fatty acids would prolong transplant survival, and only a mixture with an ω-6:ω-3 ratio of 2.1:1 would give immune-neutral results. In 1998, the label of a newly registered fish oil emulsion also acknowledged this immune-neutral ratio in conjunction with ω-6 lipids. Also, two fish oil-supplemented fat emulsions, registered in 2004, used a similar ω-6:ω-3 ratio. Such an immune-neutral ω-6:ω-3 ratio denoted progress for most patients compared to pure ω-6 lipid emulsions. However, this immune-neutrality might on the other hand be responsible for the limited positive clinical results gained so far in critically ill and surgical patients where in most cases significance could only be shown for the pooled effect of numerous trials. Our product specific metaanalysis also did not reveal any differences, neither in infections rates nor in ICU or hospital length of stay. To evaluate the immune-modulatory effect of fish oil administered alone, new dose finding studies, reporting relevant clinical outcome parameters, are required. Precise mechanistic or physiological biomarkers for the indication of such a therapy should also be developed and validated.
A randomized double-blind controlled study of 6 months of oral nutritional supplementation with arginine and omega-3 fatty acids in HIV-infected patients. Swiss HIV Cohort Study. [2019]To evaluate the effects of an oral nutritional supplement enriched with two potentially immunostimulant compounds (arginine and omega-3 fatty acids) on the changes in food intake, body composition, immune parameters and viraemia in HIV-infected outpatients.
Improvement in the plasma omega-3 index by the use of a fish oil-enriched spread. [2013]The main aim of this pilot study was to determine whether the omega-3 status can be improved by the use of a fish oil-enriched spread in a regular diet.
Evaluation of immune markers in asymptomatic AIDS patients receiving fish oil supplementation. [2019]The effects of oral fish oil (FO) supplementation (8 g/day, capsules) on nutritional status and selected immune markers (CD4/CD8 ratio, IL-1beta, erythrocyte MDA release, dehydroepiandrosterone sulfate [DHEA-S]) were studied in a homogeneous group of asymptomatic HIV-infected patients during 6 weeks. All subjects were classified clinically as A2 according to the CDC revised criteria (mean CD4 count 290 +/-123 cells/mm(3)) and were receiving zidovudine retroviral treatment. The calculated mean energy intake was 3437 +/- 372 Kcal/d, composed of 14% protein, 38% lipids and 48% carbohydrates, and was not modified during the study. The anthropometric parameters, and hematological and plasma biochemistry data showed non-significant changes after FO supplementation. Mean malonyldialdehyde (MDA) release before treatment was: unstimulated 71.5 +/- 37 and stimulated 350.9 +/- 79.8 nmol/g Hb. After FO supplementation (T(6)) MDA release showed unstimulated values of 96.1 +/- 62, and a significant increase after stimulation of 614.1 106.4 nmol/g Hb, which was, however, within the normal range. In the patient's samples, IL-1beta levels in the unstimulated blood culture showed a statistical increase with respect to the normal range before (T(0)) and after (T(6)) FO supplementation with a slight decrease after (mean 49.8 vs 40.9 pg/ml). The stimulated IL-1beta levels after treatment showed a statistically significant decrease that was maintained within the normal range (T(0): 797.7 vs T(6): 535.6 pg/ml). Taken collectively, these results suggest a tendency toward improvement in immune function.
Biological mechanisms and cardiovascular effects of omega-3 fatty acids. [2022]The mechanisms and cardiovascular effects of omega-3 fatty acids are reviewed. Omega-3 polyunsaturated fatty acids are the major ingredient found in commercially available fish oil products. The incidence of many diseases, including coronary heart disease, diabetes mellitus, and psoriasis, is lower in Eskimos, who ingest diets rich in omega-3 fatty acids, compared with European controls. Potential mechanisms by which these fatty acids cause their many physiologic effects include competing with omega-6 fatty acids for prostaglandin and leukotriene pathways and enhancing cell membrane fluidity by virtue of the high degree of unsaturation. Numerous studies have documented longer bleeding times and decreased platelet aggregation in subjects ingesting omega-3 fatty acids. Omega-3 fatty acids may reduce serum cholesterol concentrations by decreasing the synthesis of very low density lipoprotein and, therefore, low-density lipoprotein. Blood viscosity is significantly and uniformly lower in subjects receiving omega-3 fatty acids compared with controls. Potential risks of supplementation with fish oils include hypervitaminosis A and D, vitamin E deficiency, increased bleeding times, decreased platelets, and ingestion of contaminated fish. Supplementation with moderate amounts of omega-3 fatty acids appears to be relatively safe. Possible adverse effects include nausea, diarrhea, and a "fishy" taste. Properly controlled, long-term clinical trials are needed to determine whether supplementation with omega-3 fatty acids would be therapeutically beneficial in various patient populations and disease states.
Clinical applications of fish oils. [2016]Fish oil supplements are currently being nationally advertised, and many physicians are being queried about their clinical utility. Epidemiologic studies reveal a low incidence of cardiovascular disease in people, such as the Eskimos, who eat large amounts of seafood. Cardiovascular health may be improved because fish and fish oil supplements lower plasma lipid levels (especially triglycerides), inhibit platelet aggregation, and may decrease blood pressure and viscosity and increase high-density lipoprotein (HDL) levels. Preliminary observations also suggest a potential future role for fish oils in the treatment of some autoimmune diseases, such as atopic dermatitis, psoriasis, and rheumatoid arthritis. Patients with serum triglyceride levels greater than 5.64 mmol/L and/or cholesterol levels greater than 7.75 mmol/L refractory to dietary management may benefit from a medically supervised trial of fish oil supplements. Data currently available are insufficient to recommend fish oil supplements for the general public, or for patients with other diseases, and side effects must also be considered. These include occasional adverse lipid changes, potential for bleeding and vitamin E deficiency, and, with some preparations, vitamin A and D toxicity.
Oxidation levels of North American over-the-counter n-3 (omega-3) supplements and the influence of supplement formulation and delivery form on evaluating oxidative safety. [2018]The aim of the present study was to evaluate the oxidation status of North American n-3 (omega-3) PUFA nutritional supplements commercially available in Canada and evaluate the influence of product formulation and delivery form on oxidative safety. A total of 171 North American over-the-counter n-3 PUFA nutritional supplements were analysed for oxidation safety. Primary and secondary oxidation and total oxidation (TOTOX) were determined using the American Oil Chemists' Society (AOCS) procedures. Comparisons between supplements' final forms, oil source and n-3 PUFA concentration quartiles, as measures of product formulations and delivery forms, were compared using ANOVA. Of the products successfully tested, 50 % exceeded the voluntary recommended levels for markers of oxidation. Another 18 % of products were approaching the limits with 1-3 years before expiration. Encapsulated products without flavour additives had significantly lower secondary and TOTOX levels than bulk oils and flavoured products (P 0·05), with the exception of krill oil products having higher secondary oxidation levels than plant-based products (P > 0·05). Markers of oxidation did not differ between n-3 PUFA supplement concentration quartiles. Consumers may be at risk of exposure to higher levels of oxidative products. New regulatory mandates need to be introduced to ensure that all n-3 PUFA products, used as nutritional supplements, regardless of their formulation or delivery form, can be tested for oxidative safety and compliance.
Safety considerations with omega-3 fatty acid therapy. [2022]It has been suggested that the potential antithrombotic effect of fish oils may theoretically increase the risk for bleeding, which may be a safety concern for individual patients. However, clinical trial evidence has not supported increased bleeding with omega-3 fatty acid intake, even when combined with other agents that might also increase bleeding (such as aspirin and warfarin). Another potential safety concern is the susceptibility of omega-3 fatty acid preparations to undergo oxidation, which contributes to patient intolerance and potential toxicity. Finally, large amounts of fish consumption may result in adverse experiences due to the potential presence of environmental toxins such as mercury, polychlorinated biphenyls, dioxins, and other contaminants. The risks of exposure to environmental toxins and hypervitaminosis with fish consumption are substantially reduced through purification processes used to develop selected concentrated fish oil supplements and prescription preparations. Thus, in choosing which fish oil therapies to recommend, clinicians should be aware of available information to best assess their relative safety, which includes the US Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) advisory statement regarding fish consumption, the meaning of certain labeling (such as "verification" through the US Pharmacopeia) and the differences in FDA regulatory requirements between nonprescription fish oil supplements and prescription fish oil preparations, and how all of this is important to the optimal treatment of patients.
Fish oil supplementation in early infancy modulates developing infant immune responses. [2012]Maternal fish oil supplementation during pregnancy has been associated with altered infant immune responses and a reduced risk of infant sensitization and eczema.
HPLC/HRMS and GC/MS for Triacylglycerols Characterization of Tuna Fish Oils Obtained from Green Extraction. [2023]Fish oil is one of the most common lipidic substances that is consumed as a dietary supplement. The high omega-3 fatty acid content in fish oil is responsible for its numerous health benefits. Fish species such as mackerel, herring, tuna, and salmon are particularly rich in these lipids, which contain two essential omega-3 fatty acids, known as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
Comparative analysis of requirements for quality of fish oil for food and medical applications. [2018]Fish oil is reach natural source of vitamins А, Е, D and polyunsaturated fatty acids (PUFA) which are useful for supplementation, prophylaxis and therapy in food industry, medicine and veterinary. The analysis of regulatory documents for the quality of fish oil (based on concentration of main nutrients) leads to conclusion that content of vitamins A and D, and PUFA is controlled in medicinal preparations. With regard to fish oil for food application there is no unified approach. In particularly, content of vitamin D in food supplements with fish oil available on Russian market is not indicated by manufacturer or its concentration varies in 3-10 folds. Because of important biological functions and pharmacological activity, it is very important to have uniform standardization for vitamins and PUFA in fish oil for application in food industry and medicine. Development and unification of analytical methods became special attention for these reasons.
[Omega-3 fatty acid preparations--a comparative study]. [2008]Fifteen food supplements and 1 medicine, formulated as soft capsules and containing omega-3 fatty acids, were evaluated with different tests, including desegregation, determination of the anisidine and peroxide values and assay of the omega-3 acids according to the European Pharmacopoeia. All the products contained purified fish oil rich in omega-3 fatty acids, mainly eicosapentaenoic acid (C20:5; EPA) and docosahexaenoic acid (C22:6; DHA), and available as triglycerides, ethyl esters or free fatty acids. The medicinal product complied with the fixed requirements whereas 7 of the 15 food supplements deviated from 1 or more of the criteria with regard to the peroxide value and the content of 1 or more of the fattty acids.