Omega-3 Fatty Acids as Regulators of Brown Adipose Tissue During Cold Exposure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fish Oil, Placebo.
- Who it may be relevant to
- Registry conditions: Cold Exposure. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Omega-3 Fatty Acid Modulation of Brown Adipose Tissue for Arctic Resilience
Overview
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.
Interventions
- Dietary supplement 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) - Dietary supplement Placebo
For 12 weeks subjects will ingest 6 capsules per day of olive oil (each capsule contains 990 mg of olive oil)
Primary outcome measures
- Core Temperature: [Time frame: 125 minutes]
- Metabolic Measurements (indirect calorimetry): [Time frame: 125 minutes]
- Indices of Shivering [Time frame: 125 minutes]
- Minnesota Manual Dexterity Test (MMDT) [Time frame: 10 minutes]
- Thermal Perception Scales [Time frame: 125 minutes]
- Thermal Comfort (behavior) [Time frame: 125 minutes]
- Infrared Thermography [Time frame: 125 minutes]
- Cold Chamber Challenge [Time frame: 125 minutes]
- 24 Hour Dietary Recalls [Time frame: 12 weeks]
- Skin Temperature [Time frame: 125 minutes]
Secondary outcome measures (8)
- Blood Pressure [Time frame: 10 minutes]
- Urine Specific Gravity and Pregnancy Test [Time frame: 10 minutes]
- Heart Rate [Time frame: 125 minutes]
- Pulse Rate [Time frame: 10 minutes]
- Bone Mineral Density [Time frame: 10 minutes]
- Lean Muscle Mass [Time frame: 10 minutes]
- Fat Mass [Time frame: 10 minutes]
- Body Fat Percentage [Time frame: 10 minutes]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Human Perfromance Lab, Indiana University — Bloomington
Identifiers
NCT: NCT05822141 · 17715