Omega-3 Fatty Acids as Regulators of Brown Adipose Tissue During Cold Exposure

Last updated: April 4, 2025
Sponsor: Indiana University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Placebo

Fish Oil

Clinical Study ID

NCT05822141
17715
  • Ages 18-40
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This clinical trial will assess the whether fish oil supplementation can modulate brown fat activation, shivering, thermal comfort and skin blood flow during cold exposure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female, between the ages of 18 to 40 years.

  • Body Mass Index (BMI) of 18.5 to 24.9 kg/m2

  • Considered "moderately to highly active" by the International Physical ActivityQuestionnaire (IPAQ) and the Physical Activity Readiness Questionnaire (PAR-Q+)

Exclusion

Exclusion Criteria:

  • History of smoking or recreational smoking, hyperlipidemia,hypertension/cardiovascular disease, diabetes, renal disease, neurological disease,metabolic disease, and bleeding disorders or delayed clotting time.

  • Taking SSRI's (antidepressants and anxiety medication), ADD/ADHD medication, andchronically consume pain medication (Aleve, Tylenol, CBD, etc).

  • Have or have had chronic disorders of the rectum (e.g., cancer, surgery, activehemorrhoids, etc.) or who currently have related acute conditions (diarrhea,constipation, etc.).

  • Have or have had a diagnosis of disorders related to immune suppression and/orautoimmune disease.

  • Are pregnant or planning on being pregnant.

  • Resting blood pressure of > 130mmHg systolic or 90 mmHg diastolic.

  • Resting Pulse rate of > 100 bpm.

  • History of regularly consuming fish oil supplements and/or regularly eating morethan one fish meal per week.

  • Consuming more than one fish meal per week during the study.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
June 12, 2023
Estimated Completion Date:
December 31, 2025

Study Description

This proof-of-concept study will be conducted as a randomized, double-blind, placebo controlled, parallel group clinical trial in which 30 healthy men and women (ages 18-40 years) will be randomly assigned to fish oil (n=20; 7.8 g/day total n-3 PUFA: 3.75 g/day EPA and 1.5 g/day DHA) or placebo (n=20, olive oil) conditions for 12 weeks. Before beginning supplementation, and at 6- and 12-weeks post-supplementation, whole-body thermoregulation will be assessed by progressively reducing air temperature (from 29°C→4°C, with a wind speed of 4.5 m/s) over a 125-minute period in an environmental chamber. This approach will allow for quantitative determination of fish oil supplementation on body temperature regulation during cold exposure. This approach is novel because it also permits comprehensive assessment of the regulation of core body temperature (rectal temperature) and objective quantification of both autonomic [metabolic heat production (indirect calorimetry), BAT activation (infrared thermography), shivering (accelerometry, electromyography), skin blood flow (laser Doppler)] and behavioral (voluntary control of local thermal comfort) thermoregulatory responses. The advantage of this methodology is that this approach will enable assessment of whether fish oil supplementation is beneficial during exposure to cold environments.

Connect with a study center

  • Human Perfromance Lab, Indiana University

    Bloomington, Indiana 47405
    United States

    Active - Recruiting

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