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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if fish oil supplements can improve the body's response to cold by influencing factors such as brown fat activity, shivering, and skin blood flow. Participants will take either fish oil or olive oil capsules daily for 12 weeks. Ideal candidates are active adults who have not been taking fish oil supplements or consuming more than one fish meal per week. As an unphased trial, this study provides a unique opportunity to enhance scientific understanding of dietary supplements and cold adaptation.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found fish oil to be generally safe for most people when taken in doses of 3 grams or less daily. This trial uses a higher dose of 6 grams per day, which might increase the chance of side effects. Some people have reported mild issues like an upset stomach or a fishy aftertaste when taking fish oil. Choosing high-quality fish oil supplements is important, as low-quality ones might be spoiled and harmful. Overall, fish oil is well-tolerated, but participants should be aware of potential minor side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike most treatments for managing cold exposure, which often involve layering clothing or using heating devices, fish oil, rich in Omega-3 fatty acids, offers a potential internal solution. Researchers are excited about fish oil because these fatty acids might help the body adapt to cold by altering cellular membranes and improving circulation. This approach is unique because it targets the body’s internal response to cold rather than external factors, potentially offering a more integrated way to cope with chilly conditions.

What evidence suggests that fish oil could be effective for cold exposure?

This trial will compare the effects of fish oil, rich in omega-3 fatty acids, with a placebo on cold exposure. Studies have shown that fish oil may help regulate brown fat, which burns calories to generate heat, aiding in cold conditions. Research suggests that omega-3 fatty acids can lower triglyceride levels, a type of fat in the blood, potentially enhancing the body's ability to stay warm. Cold exposure can increase certain fats in the blood, which are also present in fish oil. These findings suggest that fish oil might help maintain warmth and comfort in cold weather by influencing fat and blood flow. ^{1 4 6 7 8}

Who Is on the Research Team?

Timothy D Mickleborough, PhD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05822141?term=manual%20oil&viewType=Table&checkSpell=&rank=8

Omega-3 Fatty Acids as Regulators of Brown Adipose ... This approach will allow for quantitative determination of fish oil supplementation on body temperature regulation during cold exposure. This approach is novel ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9663865/

Cold exposure induces dynamic changes in circulating ... We show that cold exposure gradually increases circulating free fatty acids and transiently decreases total TAGs after 30 min, accompanied by a dynamic change ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211926420305300

Cold and dark treatments induce omega-3 fatty acid ... We investigated the effect of 3-day cold or dark treatments on N. oceanica BR2 nutritional composition by measuring fatty acid and carotenoid profiles.

4. ods.od.nih.gov ods.od.nih.gov/factsheets/Omega3FattyAcids-HealthProfessional/

Omega-3 Fatty Acids - Health Professional Fact Sheet Each increase of 1 g/day of LC omega-3 reduced triglyceride levels by 5.9 mg/dL, and the effect was stronger in people with higher baseline triglyceride levels.

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05822141?keyword=%22COLD%22

Omega-3 Fatty Acids as Regulators of Brown Adipose ... This clinical trial will assess the whether fish oil supplementation can modulate brown fat activation, shivering, thermal comfort and skin blood flow ...

6. efsa.onlinelibrary.wiley.com efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2010.1874

Scientific Opinion on Fish Oil for Human Consumption. Food ... The project tries to find out if it is healthier to eat fish rather than ingest special products to which omega-3 fatty acids have been added, or if it is best ...

7. webmd.com webmd.com/vitamins/ai/ingredientmono-993/fish-oil

Fish Oil - Uses, Side Effects, and More When taken by mouth: Fish oil is likely safe for most people in doses of 3 grams or less daily. Taking more than 3 grams daily might increase the chance of ...

8. grassrootshealth.net grassrootshealth.net/blog/oxidized-fish-oil-supplements-may-harm-health/

Oxidized Fish Oil Supplements May Harm Your Health As many as 50% or more of the omega-3 fish oil supplements on the market are oxidized; why choosing high quality fish oil supplements is essential and how to ...