Cold ExposureNCT05822141
Omega-3 Fatty Acids as Regulators of Brown Adipose Tissue During Cold Exposure
A study testing Fish Oil in people with Cold Exposure, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cold Exposure
- What is being tested?
- Fish Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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+)
Who cannot join
- 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.
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Abigail S Sogard, B.S. contact
United States1 site, 1 recruiting
- Recruiting
Human Perfromance Lab, Indiana University
Bloomington, Indiana, 47405
Timothy Mickleborough, PhD, tmickleb@inidana.edu
About this study
Official title: Omega-3 Fatty Acid Modulation of Brown Adipose Tissue for Arctic Resilience
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.
Read the 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
- Being tested
- Fish Oil, Placebo
- Keywords
- Brown fat, Fish oil, Cold
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary 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)
PlaceboDietary supplement
For 12 weeks subjects will ingest 6 capsules per day of olive oil (each capsule contains 990 mg of olive oil)
| Study group | Role | What they receive |
|---|---|---|
| Fish Oil (Omega-3 Fatty Acids) | Experimental | 15 subjects will ingest 6 capsules of fish oil of per day for 12 weeks Receives: Dietary Supplement: Fish Oil |
| Olive Oil | Placebo comparator | 15 subjects will ingest 6 capsules of olive oil per day for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core Temperature:
Core body temperature will be continuously measured by a rectal probe
Measured: 125 minutes
Metabolic Measurements (indirect calorimetry):
Metabolic rate will be measured via indirect calorimetry (i.e., via the analysis of expired gases and ventilation).
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 minutes
Secondary outcomes (8)
Blood Pressure
Digital blood pressure cuff will evaluate resting blood pressure
Measured: 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.
Measured: 10 minutes
Heart Rate
Participants will be connected to a 3-lead electrocardiogram (ECG).
Measured: 125 minutes
Pulse Rate
Digital blood pressure cuff will evaluate resting pulse rate
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start12 Jun 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cold ExposureStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo controlled, parallel group trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Mickleborough, Indiana University
- Investigators
- Timothy D Mickleborough, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822141
- Sponsor's protocol ID
- 17715
- Status last verified
- May 2026
- First submitted
- 27 Mar 2023
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acid Modulation of Brown Adipose Tissue for Arctic Resilience
- ClinicalTrials.gov ID
- NCT05822141
- Acronym / sponsor ID
- 17715
- Conditions
- Cold Exposure
- Keywords
- Brown fat, Fish oil, Cold
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo controlled, parallel group trial
| Arm | Type | Receives |
|---|---|---|
| Fish Oil (Omega-3 Fatty Acids) | Experimental | Dietary Supplement: Fish Oil15 subjects will ingest 6 capsules of fish oil of per day for 12 weeks |
| Olive Oil | Placebo comparator | Dietary Supplement: Placebo15 subjects will ingest 6 capsules of olive oil per day for 12 weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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+)
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish OilFor 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 | Fish Oil (Omega-3 Fatty Acids) |
| PlaceboFor 12 weeks subjects will ingest 6 capsules per day of olive oil (each capsule contains 990 mg of olive oil) | Dietary supplement | Olive Oil |
Primary outcome
Core Temperature:
Time frame: 125 minutes
Core body temperature will be continuously measured by a rectal probe
Metabolic Measurements (indirect calorimetry):
Time frame: 125 minutes
Metabolic rate will be measured via indirect calorimetry (i.e., via the analysis of expired gases and ventilation).
Indices of Shivering
Time frame: 125 minutes
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
Minnesota Manual Dexterity Test (MMDT)
Time frame: 10 minutes
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.
Thermal Perception Scales
Time frame: 125 minutes
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).
Thermal Comfort (behavior)
Time frame: 125 minutes
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
Infrared Thermography
Time frame: 125 minutes
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
Cold Chamber Challenge
Time frame: 125 minutes
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).
24 Hour Dietary Recalls
Time frame: 12 weeks
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.
Skin Temperature
Time frame: 125 minutes
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.
Nine Hole Peg Test (NHPT)
Time frame: 10 minutes
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abigail S Sogard, B.S. contact
Timothy D Mickleborough, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish Oil in people with Cold Exposure, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timothy D Mickleborough, PhD (812-855-0753, tmickleb@indiana.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core Temperature: (time frame: 125 minutes). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.