20 Participants Needed

Cooling Vest Procedure and Fasting overnight for Healthy Lifestyle

RS
KP
Overseen ByKaja Plucinska, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Brown adipose tissue (BAT) burns excess calories to produce heat in response to environmental cold. Rapidly growing evidence from rodent and human studies suggests that the presence and activation of brown fat are far more beneficial for whole body metabolism and cardiometabolic health than previously appreciated. Despite the clear associations between brown fat and metabolic health, we lack both: cost-effective means of detecting brown fat in humans as well as comprehensive insights into how brown fat facilitates metabolism on a molecular level in humans. Emerging evidence suggests that the benefits of brown fat activation are mediated, at least in part, by secretion of specific molecules into the bloodstream which signal to metabolically active organs such as skeletal muscle, liver and brain. A number of these so-called brown adipokines (or BATokines) have now been discovered in mice and shown to positively impact glucose homeostasis, liver and muscle function. Human deep-neck brown fat biopsies reveal that \>1000 molecules could potentially be secreted from brown fat, and \>400 are released by human brown fat cells in a dish, representing a major opportunity for discovery of high translational value. Here, we aim to identify a screen of first potential blood biomarkers of brown fat in healthy young humans. This will be achieved by analyzing plasma proteins in subjects with 'inactive brown fat' (warm) and 'activated brown fat' (3-hr cold exposure, cooling vests) using high-throughput technologies (SOMAscan and O-link) to identify temperature-sensitive brown fat-enriched molecules. This preliminary data will guide a larger follow up study in which we envision studying lean and obese (insulin sensitive and insulin resistant) subjects of various age groups and race/ethnicity. Human BATokines identified here will become primary targets for manipulation in experimental animals to assess their therapeutic potential against obesity, T2D, and associated diseases. Additionally, since current methods of brown fat detection in human rely on deep neck biopsies or costly 18-FDG-PET/CT scans, identification of blood biomarkers of brown fat would offer a cost-effective and non-invasive alternative for prediction of metabolic health in humans.

Research Team

KP

Kaja Plucinska, PhD

Principal Investigator

The Rockefeller University

PC

Paul Cohen, PhD

Principal Investigator

The Rockefeller University

Eligibility Criteria

This trial is for healthy young adults aged 18-28 with a BMI between 19 and 25. Participants should not be on weight loss treatments or have diabetes, thyroid disease, cancer, Raynaud's Syndrome, systemic sclerosis, recent COVID-19 infection or vaccine shots. Pregnant individuals or those on certain medications (except oral contraceptives) are excluded.

Inclusion Criteria

Age between 18 and 28
BMI >19 and < 25

Exclusion Criteria

You cannot use any treatments or supplements that are meant to help you lose weight or change your metabolism, except for vitamins which are allowed.
Any vaccine administration within two weeks preceding the study procedure
You have been diagnosed with either type 1 or type 2 diabetes.
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Treatment Details

Interventions

  • Cooling Vest Procedure
  • Fasting overnight
Trial OverviewThe study tests if wearing cooling vests can activate brown fat in the body and lead to the release of BATokines into the blood. These molecules might help regulate metabolism and improve cardiometabolic health. The trial involves fasting overnight followed by exposure to cold using cooling vests.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Cold ExposureExperimental Treatment1 Intervention
The cold vest procedure: The first blood draw will be taken from participants before the cooling procedure (time 0, 30mL blood). Participants will then be requested to put on hospital scrubs and the cooling vest will be placed on them. Since muscle shivering is an alternative way of heat production (skeletal thermogenesis), we will first determine individual 'shivering threshold' for each participant (coldest tolerable temperature; typically 14°C / 57.2F), based on participant-report and direct observation. The cold vest will then be kept on for 3 hours with a temp set to the coldest tolerable temperature (shivering threshold +2°C (\~16-17°C / 60.8F-62.6F) and body temperature will be monitored by a tympanic thermometer. Following 3 hours, 30mL of blood will be drawn (Time 180min). All participants will be re-warmed with blankets after cooling has been completed, and offered a warm drink and a snack.
Group II: Fasted procedure without coolingActive Control1 Intervention
This arm has been added in order to exclude the effects of prolonged fasting on blood analytes. Previously enrolled participants will be re-invited to donate blood after 12hr fast and 3hrs later (15hr fast) without the cooling procedure. Participants will be re-consented for this lab appointment. The night prior the visit, the participants will be instructed to fast from 10:00pm. At the time of visit vital signs and anthropomorphic measurements will be taken. Blood Draw: The first blood draw will take place in the morning. Participant will then be asked to sit in the procedure room for 3 hours at room temperature; second blood draw will take place after 3 hrs. Total of 38ml of blood will be drawn. Blood will be used for clinical labs (fasting glucose, Hba1c, TSH, TG) and research.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rockefeller University

Lead Sponsor

Trials
162
Recruited
16,700+

Beth Israel Deaconess Medical Center

Collaborator

Trials
872
Recruited
12,930,000+