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

Indiana University

Status: Enrolling

Conditions: Cold Exposure

Treatments: Dietary Supplement: Fish Oil; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05822141

17715

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Fish Oil (Omega-3 Fatty Acids)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Fish Oil

Olive Oil

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo