Recruiting

Omega-3 Fatty Acids

Sponsor:

Indiana University

Code:

NCT05822141

Conditions

Cold Exposure

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Fish Oil

Placebo

Study Details

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

Study ID

NCT05822141

Start date

Jun 12, 2023

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Fish Oil (Omega-3 Fatty Acids)

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

placebo comparator: Olive Oil

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

Interventions

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)

Placebo

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

Primary outcome measure

  • 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 ]
  • Nine Hole Peg Test (NHPT) [ Time Frame: 10 minutes ]

Central Contacts and Locations

Central contacts

Timothy D Mickleborough, PhD

812-855-0753tmickleb@indiana.edu

Abigail S Sogard, B.S.

asogard@iu.edu

Locations

Human Perfromance Lab, Indiana University

Recruiting

Bloomington, Indiana, United States, 47405

Contacts

Timothy Mickleborough, PhD

tmickleb@inidana.edu

More Information

Sponsor

Indiana University

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • Brown fat
  • Fish oil
  • Cold

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-05-26.