An interventional study of Fish Oil and Placebo in Cold Exposure, sponsored by Indiana University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Indiana University · Not applicable, Interventional, and Basic science
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.
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.
219 studies on the registry are indexed under Common Cold; 23 are open to participants now.
This study's planned enrollment of 30 is below the median of 150 across 184 interventional studies indexed under Common Cold.
Browse Common Cold studies →Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
15 subjects will ingest 6 capsules of fish oil of per day for 12 weeks
Dietary Supplement: Fish Oil
15 subjects will ingest 6 capsules of olive oil per day for 12 weeks
Dietary Supplement: Placebo
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)
For 12 weeks subjects will ingest 6 capsules per day of olive oil (each capsule contains 990 mg of olive oil)
Core Temperature:
Core body temperature will be continuously measured by a rectal probe
Time frame: 125 minutes
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
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
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
Thermal Perception Scales
Thermal perceptions will be assessed using Likert scales for thermal discomfort and thermal sensation. Thermal perceptions will be assessed using Likert scales for thermal discomfort and thermal sensation. Participants will complete Likert scales to assess their thermal comfort (1 = comfortable, 4 = very uncomfortable) and thermal sensation (1 = cold, 4 = neutral, 7 = hot).
Time frame: 125 minutes
Thermal Comfort (behavior)
A series of small tubes will be placed on the back of the participant's neck. The participants will control the temperature of the water perfusing these tubes by turning a valve. This will allow for the voluntary control of neck temperatures from 20-35 degrees Celsius. Participants will be instructed to control the temperature of the water bath so that their neck will always be thermally comfortable
Time frame: 125 minutes
Infrared Thermography
An infrared thermography camera will be used to measure skin temperature in the supraclavicular (i.e., collar bone) region. This provides a non-invasive estimate of brown adipose tissue activation
Time frame: 125 minutes
Cold Chamber Challenge
The environmental chamber set to 29 degrees Celsius (C; 84 degrees Fahrenheit, F) at the beginning of the experimental visit. While in the chamber, participants will be instructed to be sedentary. The chamber will then be cooled at a rate of 1 deg C per 5 minutes until 4 deg C (39.2 deg F) is reached (\~125 minutes) with a wind speed of 4.5 m/s. Once 4 deg C air temperature is reached, participants will remain in the chamber for an additional 30 minutes or until the participant can no longer tolerate the cold or if rectal temperature falls below 35.5 deg C (95.9 deg F).
Time frame: 125 minutes
24 Hour Dietary Recalls
Participants will be asked to record all food, beverages and supplements consumed during a 24-hour period pre-supplementation, and every 2 weeks during the supplementation period for a total of \~7 dietary recalls to ensure that dietary habits do not change during the 12 week supplementation period.
Time frame: 12 weeks
Skin Temperature
Wireless temperature sensors (iButtons, Maxim Inc.) will be attached to 12 sites on the body (forehead, calf, thigh, foot, quadriceps, hamstring, chest, abdomen, upper back, lower back, forearm, and hand) using adhesive tape to measure skin temperature.
Time frame: 125 minutes
Nine Hole Peg Test (NHPT)
The NHPT, a manual dexterity test, consists of 9 holes (10mm diameter, 15mm depth) separated by 32mm, and 9 pegs (7mm diameter, 32mm length). During the test, participants will be instructed to take the pegs from a container one by one and place them into the holes on the board as quickly as possible, with their dominant hand. Scoring of this test is the time it takes to complete each test.
Time frame: 10 minutes
Blood Pressure
Digital blood pressure cuff will evaluate resting blood pressure
Time frame: 10 minutes
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
Heart Rate
Participants will be connected to a 3-lead electrocardiogram (ECG).
Time frame: 125 minutes
Pulse Rate
Digital blood pressure cuff will evaluate resting pulse rate
Time frame: 10 minutes
Bone Mineral Density
A total-body Dual Energy X-Ray Absorptiometry (DEXA) procedure will be used to assess bone mineral density (g. cm-3) at various body segments (e.g., total body, trunk, hip, leg).
Time frame: 10 minutes
Lean Muscle Mass
A total-body Dual Energy X-Ray Absorptiometry (DEXA) procedure will be used to assess lean muscle mass (kilograms or pounds) at various body segments (e.g., total body, trunk, hip, leg).
Time frame: 10 minutes
Fat Mass
A total-body Dual Energy X-Ray Absorptiometry (DEXA) procedure will be used to assess fat mass (kilograms or pounds) at various body segments (e.g., total body, trunk, hip, leg).
Time frame: 10 minutes
Body Fat Percentage
A total-body Dual Energy X-Ray Absorptiometry (DEXA) procedure will be used to assess body fat percentage (%) at various body segments (e.g., total body, trunk, hip, leg).
Time frame: 10 minutes
Plan to share: No
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Studies of the drug tested here: Fish Oils