Omega-3 Supplements for Omega-3 Deficiency

Recruiting at 1 trial location

Overseen By Crawford Currie, MBBS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hofseth Biocare ASA

Disqualifiers: Fish allergies, Pregnant, Fish oil, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 14 weeks

96 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{5 7 11 12 13}

Research Team

Crawford Currie, MBBS

Principal Investigator

HBC

Eligibility 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.

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

Treatment Details

Interventions

• Whole Salmon Oil

Trial Overview 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.

Participant Groups

Group I: Omega-3 cod liver oil soft gel capsules Active Control 1 Intervention

A standard, processed, concentrated omega-3 supplement

Group II: CARDIO salmon oil soft gel capsules Active Control 1 Intervention

A minimally processed, whole salmon oil containing all the fatty acid fractions found in salmon

Who Is Running the Clinical Trial?

Hofseth Biocare ASA

Lead Sponsor

Trials

8

Recruited

610+

Findings from Research

An increased supply of energy, protein, essential fatty acids, and vitamin A in very-low-birth-weight infants led to faster weight regain and improved growth velocity compared to a control group, with significant differences in growth metrics (P<0.001).

However, the study was discontinued due to a higher occurrence of septicemia in the intervention group, highlighting potential safety concerns despite the efficacy in promoting growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced feeding and diminished postnatal growth failure in very-low-birth-weight infants. Moltu, SJ., Blakstad, EW., Strømmen, K., et al.[2022]

Intravenous fish oil administration has shown potential immune-modulatory effects, particularly with a specific ω-6:ω-3 fatty acid ratio of 2.1:1, which may prolong transplant survival and provide immune-neutral results for patients.

However, a meta-analysis of existing studies found no significant differences in infection rates or length of ICU and hospital stays for critically ill and surgical patients, indicating that more targeted research is needed to fully understand the clinical benefits of fish oil therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous fish oil in critically ill and surgical patients - Historical remarks and critical appraisal. Kreymann, KG., Heyland, DK., de Heer, G., et al.[2019]

In a six-month study involving 64 HIV-infected outpatients, an oral nutritional supplement enriched with arginine and omega-3 fatty acids did not lead to significant improvements in immune parameters such as CD4 and CD8 lymphocyte counts or viraemia.

Both groups experienced a similar increase in body weight and fat mass, indicating that while the enriched supplement did not enhance immune function, it was effective in promoting weight gain in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Pichard, C., Sudre, P., Karsegard, V., et al.[2019]

The pilot study demonstrated that incorporating a fish oil-enriched spread into a regular diet significantly increased the omega-3 index in participants' red blood cells and plasma after just 3 weeks.

In contrast, the control spread did not produce any significant changes in omega-3 levels, highlighting the efficacy of the fish oil-enriched spread in improving omega-3 status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in the plasma omega-3 index by the use of a fish oil-enriched spread. De Groote, G., De Laporte, A., Dhondt, G., et al.[2013]

In a 6-week study of 8 g/day oral fish oil supplementation in asymptomatic HIV-infected patients, there were no significant changes in nutritional status or anthropometric measurements, indicating safety in this population.

Fish oil supplementation led to a significant decrease in stimulated IL-1beta levels, suggesting a potential improvement in immune function, despite some increases in malonyldialdehyde (MDA) release that remained within normal ranges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of immune markers in asymptomatic AIDS patients receiving fish oil supplementation. Virgili, N., Farriol, M., Castellanos, JM., et al.[2019]

Omega-3 fatty acids, commonly found in fish oil, have been associated with lower incidences of diseases like coronary heart disease and diabetes, likely due to their effects on inflammation and blood viscosity.

While omega-3 supplementation appears to be relatively safe, potential risks include increased bleeding times and gastrointestinal issues, highlighting the need for further long-term studies to confirm their therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological mechanisms and cardiovascular effects of omega-3 fatty acids. Mueller, BA., Talbert, RL.[2022]

Fish oil supplements may improve cardiovascular health by lowering triglyceride levels, inhibiting platelet aggregation, and potentially decreasing blood pressure, but current data does not support their use for the general public.

Patients with high triglyceride or cholesterol levels that do not respond to diet may benefit from fish oil supplements under medical supervision, although potential side effects like bleeding and vitamin toxicity must be considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical applications of fish oils. Yetiv, JZ.[2016]

About 50% of the 171 analyzed omega-3 PUFA supplements exceeded recommended oxidation levels, indicating a potential risk for consumers regarding oxidative safety.

Encapsulated omega-3 supplements without flavor additives showed significantly lower oxidation levels compared to bulk oils and flavored products, while children's supplements had the highest oxidation levels, suggesting a need for better regulation and safety testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Jackowski, SA., Alvi, AZ., Mirajkar, A., et al.[2018]

Clinical trials have shown that omega-3 fatty acid intake from fish oils does not increase the risk of bleeding, even when taken with other blood-thinning medications like aspirin and warfarin, suggesting it is safe for patients.

Purified fish oil supplements significantly reduce the risks associated with environmental toxins and hypervitaminosis, making them a safer option compared to consuming large amounts of fish, which may contain harmful contaminants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations with omega-3 fatty acid therapy. Bays, HE.[2022]

In a study involving 420 high atopic risk infants, daily fish oil supplementation from birth to 6 months significantly increased levels of beneficial omega-3 fatty acids (DHA and EPA) and decreased levels of arachidonic acid, which is linked to inflammatory responses.

The fish oil group showed lower allergen-specific Th2 responses (like IL-13) and higher Th1 responses (like IFNγ and TNF), suggesting that postnatal fish oil may help modulate the immune system in a way that could protect against allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fish oil supplementation in early infancy modulates developing infant immune responses. D'Vaz, N., Meldrum, SJ., Dunstan, JA., et al.[2012]

The study successfully identified and quantified 81 triglycerides in crude tuna fish oil, highlighting its richness in beneficial omega-3 fatty acids, specifically eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

The tuna fish oil was produced using an environmentally friendly, low-temperature method that minimized the formation of harmful trans fatty acids, ensuring a safer and healthier product.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HPLC/HRMS and GC/MS for Triacylglycerols Characterization of Tuna Fish Oils Obtained from Green Extraction. Indelicato, S., Di Stefano, V., Avellone, G., et al.[2023]

Fish oil is a valuable source of vitamins A, D, E, and polyunsaturated fatty acids (PUFAs), which are important for health and have applications in medicine and food industries.

There is a lack of standardized regulations for the vitamin D content in fish oil supplements in the food market, leading to significant variations in concentration, highlighting the need for uniform quality control and analytical methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative analysis of requirements for quality of fish oil for food and medical applications. Kosman, VM., Demchenko, DV., Pozharitskaya, ON., et al.[2018]

Out of 15 food supplements and 1 medicine containing omega-3 fatty acids evaluated, 7 food supplements did not meet one or more quality criteria, particularly regarding peroxide values and fatty acid content.

The medicinal product containing omega-3 fatty acids complied with all fixed requirements, indicating it is a reliable option compared to some of the food supplements tested.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Omega-3 fatty acid preparations--a comparative study]. Fierens, C., Corthout, J.[2008]

References

1. United States pubmed.ncbi.nlm.nih.gov

Enhanced feeding and diminished postnatal growth failure in very-low-birth-weight infants. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Intravenous fish oil in critically ill and surgical patients - Historical remarks and critical appraisal. [2019]

3. England pubmed.ncbi.nlm.nih.gov

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]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Improvement in the plasma omega-3 index by the use of a fish oil-enriched spread. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of immune markers in asymptomatic AIDS patients receiving fish oil supplementation. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Biological mechanisms and cardiovascular effects of omega-3 fatty acids. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Clinical applications of fish oils. [2016]

8. England pubmed.ncbi.nlm.nih.gov

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]

9. United States pubmed.ncbi.nlm.nih.gov

Safety considerations with omega-3 fatty acid therapy. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Fish oil supplementation in early infancy modulates developing infant immune responses. [2012]

11. Switzerland pubmed.ncbi.nlm.nih.gov

HPLC/HRMS and GC/MS for Triacylglycerols Characterization of Tuna Fish Oils Obtained from Green Extraction. [2023]

12. Russia (Federation) pubmed.ncbi.nlm.nih.gov

Comparative analysis of requirements for quality of fish oil for food and medical applications. [2018]

13. Belgium pubmed.ncbi.nlm.nih.gov

[Omega-3 fatty acid preparations--a comparative study]. [2008]