Health TrialsbyHealthPanel

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

ConditionCold Exposure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorIndiana University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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+)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fish Oil

    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)

  • Placebo

    Dietary supplement

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Fish Oil (Omega-3 Fatty Acids)Experimental treatment 1 intervention
Group B: Olive OilPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Core Temperature:

Core body temperature will be continuously measured by a rectal probe

Time frame
125 minutes
2

Metabolic Measurements (indirect calorimetry):

Metabolic rate will be measured via indirect calorimetry (i.e., via the analysis of expired gases and ventilation).

Time frame
125 minutes
3

Indices of Shivering

Surface mechanomyography will be assessed by three triaxial accelerometers adhered to the skin using adhesive tape on the chest, upper back, and thigh will be used to assess shivering

Time frame
125 minutes
4

Minnesota Manual Dexterity Test (MMDT)

The MMDT \[28,29,30\] consists of a 60-hole, thin board with red and black blocks (3.7cm) and is comprised of the turning test and the placing test. During the turning test will be modified to only use the dominant hand. During this task, the participant takes a block from the top right corner with their dominant and places it in the hole with their dominant hand. During the placing test, the participant takes one at a time in their dominant hand and places the black in the whole on the board. Scoring of this test is the time it takes to complete each test.

Time frame
10 minutes

Secondary outcomes

1

Blood Pressure

Digital blood pressure cuff will evaluate resting blood pressure

Time frame
10 minutes
2

Urine Specific Gravity and Pregnancy Test

Hydration status via urine specific gravity (USG) by a handheld refractometer will be utilized and USG \< 1.020 will indicate euhydration. For females of child-bearing potential, a small sample of urine will be used for a urine pregnancy test.

Time frame
10 minutes
3

Heart Rate

Participants will be connected to a 3-lead electrocardiogram (ECG).

Time frame
125 minutes
4

Pulse Rate

Digital blood pressure cuff will evaluate resting pulse rate

Time frame
10 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Source ClinicalTrials.gov
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