What side effects are associated with this type of intervention?

Omega-3 fatty acid supplementation, commonly derived from fish oil, is generally well-tolerated but can have some side effects. The most frequently reported side effects include gastrointestinal issues such as diarrhea, nausea, and fishy aftertaste. In some cases, high doses may increase the risk of bleeding due to their blood-thinning properties. Additionally, some individuals may experience allergic reactions or interactions with other medications, such as anticoagulants. It is important to consult with a healthcare provider before starting omega-3 supplements, especially for individuals with underlying health conditions or those taking other medications.

What prior FDA approvals exist?

There are no specific FDA approvals mentioned in the provided context for the treatment of cold exposure using fish oil supplementation or omega-3 fatty acids. Generally, omega-3 fatty acids are known for their anti-inflammatory and metabolic effects, and they are commonly used in various conditions such as cardiovascular diseases and dry eye syndrome. However, their use for cold exposure is still under investigation, as indicated by ongoing clinical trials assessing their potential benefits in modulating brown fat activation and other physiological responses to cold.

What other types of research exist?

Promising alternatives to fish oil supplementation for cold exposure patients include: 1) Plant-based omega-3 sources such as flaxseed oil, chia seeds, and algae oil, which provide ALA that can be converted to EPA and DHA in the body. 2) Antioxidant supplements like vitamin E and C, which can help reduce inflammation. 3) Polyphenol-rich foods and supplements, such as those containing resveratrol or curcumin, known for their anti-inflammatory properties. 4) Lifestyle modifications like regular physical exercise, which can enhance metabolic function and improve cold tolerance. Consulting with a healthcare provider is essential to tailor these alternatives to individual needs.

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Omega-3 Fatty Acids

Fish Oil for Cold Exposure

N/A

Recruiting

Led By Timothy D Mickleborough, PhD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 125 minutes

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Fish oil may cause minor side effects like nausea, belching with a fishy taste in the mouth, bloating and diarrhea. It might also increase bleeding time in people prone to bleeding disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 125 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~125 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 125 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

24 Hour Dietary Recalls

Cold Chamber Challenge

Core Temperature

+8 more

Secondary study objectives

Blood Pressure

Body Fat Percentage

Bone Mineral Density

+5 more

Side effects data

From 2007 Phase 1 & 2 trial • 39 Patients • NCT00090402

15%

Dizziness

15%

cold

Falls

Heart Failure

100%

80%

60%

40%

20%

Study treatment Arm

Fish Oil

Fish Oil Plus Lipoic Acid

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Fish Oil (Omega-3 Fatty Acids)Experimental Treatment1 Intervention

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

Group II: Olive OilPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fish Oil

2006

Completed Phase 4

~1320

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cold exposure include thermal insulation, active warming, and nutritional interventions such as omega-3 fatty acid supplementation. Omega-3 fatty acids, found in fish oil, have anti-inflammatory and metabolic effects that can modulate brown fat activation, enhance thermal comfort, and improve skin blood flow during cold exposure. These mechanisms are crucial for cold exposure patients as they help maintain body temperature, reduce the risk of hypothermia, and improve overall comfort and physiological responses to cold environments.

The effects and safety of omega-3 fatty for acute lung injury: a systematic review and meta-analysis.The PBMC transcriptome profile after intake of oxidized versus high-quality fish oil: an explorative study in healthy subjects.Short-term infusion of a fish oil-based lipid emulsion modulates fatty acid status, but not immune function or (anti)oxidant balance: a randomized cross-over study.