Clinical trial NCT05822141: Omega-3 Fatty Acids as Regulators of Brown Adipose Tissue During Cold Exposure
Official title: Omega-3 Fatty Acid Modulation of Brown Adipose Tissue for Arctic Resilience
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cold Exposure
Keywords: Brown fat
Fish oil
Cold
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo controlled, parallel group trial
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Core Temperature:
timeFrame: 125 minutes
measure: Metabolic Measurements (indirect calorimetry):
timeFrame: 125 minutes
measure: Indices of Shivering
timeFrame: 125 minutes
measure: Minnesota Manual Dexterity Test (MMDT)
timeFrame: 10 minutes
measure: Thermal Perception Scales
timeFrame: 125 minutes
measure: Thermal Comfort (behavior)
timeFrame: 125 minutes
measure: Infrared Thermography
timeFrame: 125 minutes
measure: Cold Chamber Challenge
timeFrame: 125 minutes
measure: 24 Hour Dietary Recalls
timeFrame: 12 weeks
measure: Skin Temperature
timeFrame: 125 minutes
measure: Nine Hole Peg Test (NHPT)
timeFrame: 10 minutes
Secondary outcomes:
measure: Blood Pressure
timeFrame: 10 minutes
measure: Urine Specific Gravity and Pregnancy Test
timeFrame: 10 minutes
measure: Heart Rate
timeFrame: 125 minutes
measure: Pulse Rate
timeFrame: 10 minutes
measure: Bone Mineral Density
timeFrame: 10 minutes
measure: Lean Muscle Mass
timeFrame: 10 minutes
measure: Fat Mass
timeFrame: 10 minutes
measure: Body Fat Percentage
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Human Perfromance Lab, Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Timothy D Mickleborough, PhD
role: PRINCIPAL_INVESTIGATOR
References: