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

NCT05822141 | Recruiting DMC

• 1 other identifier: 17715
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cold Exposure

Keywords

Brown fat; Fish oil; Cold

Outcome Measures

Primary Outcomes (11)

• Core Temperature:

  Core body temperature will be continuously measured by a rectal probe

  125 minutes

• Metabolic Measurements (indirect calorimetry):

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

  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

  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.

  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).

  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

  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

  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).

  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.

  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.

  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.

  10 minutes

Secondary Outcomes (8)

• Blood Pressure

  10 minutes

• Urine Specific Gravity and Pregnancy Test

  10 minutes

• Heart Rate

  125 minutes

• Pulse Rate

  10 minutes

• Bone Mineral Density

  10 minutes

Study Arms (2)

Fish Oil (Omega-3 Fatty Acids)

EXPERIMENTAL

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

Dietary Supplement: Fish Oil

Olive Oil

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

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)

Fish Oil (Omega-3 Fatty Acids)

Placebo DIETARY_SUPPLEMENT

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

Olive Oil

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Human Perfromance Lab, Indiana University

Bloomington, Indiana, 47405, United States

RECRUITING

MeSH Terms

Conditions

Common Cold

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Timothy D Mickleborough, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy D Mickleborough, PhD

CONTACT

812-855-0753; tmickleb@indiana.edu

Abigail S Sogard, B.S.

CONTACT

asogard@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Kinesiology

Model Details: Randomized, double-blind, placebo controlled, parallel group trial

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 20, 2023
• Study Start: June 12, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)