Fish Oil for Cold Exposure

Overseen By Abigail S Sogard, B.S.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: SSRIs, ADD/ADHD, Pain meds

Disqualifiers: Smoking, Hypertension, Diabetes, Autoimmune, others

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test if taking fish oil supplements helps healthy adults aged 18-40 manage cold better by affecting their body's heat production and blood flow. Fish oil supplements, rich in omega-3 fatty acids, have been studied for various health benefits including cardiovascular health, glucose metabolism, and lipid profile improvements.

Will I have to stop taking my current medications?

If you are taking SSRIs, ADD/ADHD medication, or regularly using pain medication like Aleve or Tylenol, you cannot participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the trial coordinators.

What data supports the effectiveness of the fish oil treatment for cold exposure?

Fish oil, rich in omega-3 fatty acids, has shown anti-inflammatory effects in other conditions, which might help reduce inflammation-related symptoms. However, its effectiveness specifically for cold exposure is not directly supported by the available research. ^{1 2 3 4 5}

Is fish oil safe for human use?

Fish oil, which contains omega-3 fatty acids, is generally considered safe for humans when taken in moderate amounts. However, potential side effects include nausea, diarrhea, a 'fishy' taste, and increased bleeding times. It's important to choose purified fish oil supplements to reduce the risk of exposure to environmental toxins like mercury. ^{6 7 8 9 10}

How does fish oil treatment for cold exposure differ from other treatments?

Fish oil is unique because it contains omega-3 fatty acids, which have anti-inflammatory and immune-modulating effects. Unlike other treatments, fish oil is not widely used in parenteral (intravenous) nutrition, and its anti-inflammatory properties may help modulate immune responses, which could be beneficial in managing cold exposure. ^{4 7 8 11 12}

Research Team

Timothy D Mickleborough, PhD

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for active men and women aged 18-40 with a BMI of 18.5 to 24.9, who don't smoke or have bleeding disorders, immune/autoimmune diseases, metabolic or heart disease, hypertension, renal or neurological issues. They shouldn't be taking SSRIs, ADHD meds, painkillers regularly; consume fish oil supplements or more than one fish meal weekly; have rectal disorders; be pregnant; or have high blood pressure/pulse rate.

Inclusion Criteria

Your body mass index (BMI) falls within the healthy range of 18.5 to 24.9 kg/m2.

You are physically active according to the International Physical Activity Questionnaire (IPAQ) and the Physical Activity Readiness Questionnaire (PAR-Q+).

Exclusion Criteria

You have a history of problems with bleeding or blood clotting.

You have a history of smoking or using tobacco products.

You have a history of high cholesterol.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to fish oil or placebo conditions for 12 weeks. Whole-body thermoregulation is assessed at 6 and 12 weeks.

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Fish Oil
• Placebo

Trial Overview The study tests if fish oil supplements can influence brown fat activity and the body's response to cold exposure compared to a placebo. Participants will experience cold conditions while their shivering responses, thermal comfort levels and skin blood flow are monitored.

Participant Groups

Group I: Fish Oil (Omega-3 Fatty Acids) Experimental Treatment 1 Intervention

15 subjects will ingest 6 capsules of fish oil of per day for 12 weeks

Group II: Olive Oil Placebo Group 1 Intervention

15 subjects will ingest 6 capsules of olive oil per day for 12 weeks

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

Three short perioperative infusions of n-3 PUFAs reduce systemic inflammation induced by cardiopulmonary bypass surgery: a randomized controlled trial. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Intravenous Lipid Emulsions to Deliver Bioactive Omega-3 Fatty Acids for Improved Patient Outcomes. [2020]

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

Fish oil-fed mice have impaired resistance to influenza infection. [2023]

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

Immunosuppressive effects of fish oil in normal human volunteers: correlation with the in vitro effects of eicosapentanoic acid on human lymphocytes. [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

Effects of fish oil in parenteral nutrition. [2019]

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

Clinical applications of fish oils. [2016]

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

Potential adverse effects of omega-3 Fatty acids in dogs and cats. [2016]

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

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

11. England pubmed.ncbi.nlm.nih.gov

Effect of fish oil supplement administration method on tolerability and adherence: a randomized pilot clinical trial. [2022]

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

Effects of fish oil on cytokines and immune functions of mice with murine AIDS. [2021]