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

NCT ID: NCT05822141

Last Updated: 2025-04-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-12
• Study Completion Date: 2025-12-31

Brief 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.

Detailed 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.

Conditions

Cold Exposure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Fish Oil (Omega-3 Fatty Acids)

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

Group Type: EXPERIMENTAL

Fish Oil

Intervention Type: DIETARY_SUPPLEMENT

For 12 weeks subjects will ingest 6 capsules per day of fish oil (7.8 g/day total omega--3 fatty acids: 3.75 g/day EPA and 1.5 g/day DHA)

Olive Oil

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

For 12 weeks subjects will ingest 6 capsules per day of olive oil (each capsule contains 990 mg of olive oil)

Interventions

Fish Oil

For 12 weeks subjects will ingest 6 capsules per day of fish oil (7.8 g/day total omega--3 fatty acids: 3.75 g/day EPA and 1.5 g/day DHA)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

For 12 weeks subjects will ingest 6 capsules per day of olive oil (each capsule contains 990 mg of olive oil)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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 Activity Questionnaire (IPAQ) and the Physical Activity Readiness Questionnaire (PAR-Q+)

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, and chronically consume pain medication (Aleve, Tylenol, CBD, etc).
• Have or have had chronic disorders of the rectum (e.g., cancer, surgery, active hemorrhoids, etc.) or who currently have related acute conditions (diarrhea, constipation, etc.).
• Have or have had a diagnosis of disorders related to immune suppression and/or autoimmune 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 more than one fish meal per week.
• Consuming more than one fish meal per week during the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Tim Mickleborough

Professor of Kinesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy D Mickleborough, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Human Perfromance Lab, Indiana University

Bloomington, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Timothy D Mickleborough, PhD

Role: CONTACT

tmickleb@indiana.edu

812-855-0753

Abigail S Sogard, B.S.

Role: CONTACT

asogard@iu.edu

Facility Contacts

Timothy Mickleborough, PhD

Role: primary

tmickleb@inidana.edu

Other Identifiers

17715

Identifier Type: -

Identifier Source: org_study_id