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Cooling Vest Procedure and Fasting overnight for Healthy Lifestyle

N/A
Waitlist Available
Led By Kaja Plucinska, PhD
Research Sponsored by Rockefeller University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and after a 3 hour cooling procedure
Awards & highlights

Study Summary

This trial is aiming to identify potential blood biomarkers for brown fat in humans in order to assess the therapeutic potential against obesity, T2D, and associated diseases.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Potential side effects may include discomfort from cold exposure due to the cooling vest procedure and hunger from fasting overnight. However, since this is a non-invasive study focusing on healthy individuals, significant side effects are not anticipated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after a 3 hour cooling procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after a 3 hour cooling procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Identification of cold-regulated blood proteome
Secondary outcome measures
Changes in HbA1c post cooling procedure using absorbance assay
Changes in TSH post cooling procedure using absorbance assay
Changes in insulin post cooling procedure using enzyme-linked immunosorbent assay (ELISA)
+1 more

Trial Design

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 Location

Who is running the clinical trial?

Rockefeller UniversityLead Sponsor
158 Previous Clinical Trials
16,337 Total Patients Enrolled
Beth Israel Deaconess Medical CenterOTHER
836 Previous Clinical Trials
13,010,316 Total Patients Enrolled
Kaja Plucinska, PhDPrincipal InvestigatorThe Rockefeller University

Media Library

Cooling Vest Procedure Clinical Trial Eligibility Overview. Trial Name: NCT05050240 — N/A
Healthy Lifestyle Research Study Groups: Cold Exposure, Fasted procedure without cooling
Healthy Lifestyle Clinical Trial 2023: Cooling Vest Procedure Highlights & Side Effects. Trial Name: NCT05050240 — N/A
Cooling Vest Procedure 2023 Treatment Timeline for Medical Study. Trial Name: NCT05050240 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
BATokines as Biomarkers of Brown Fat in Humans
2021. "BATokines as Biomarkers of Brown Fat in Humans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05050240.
~6 spots leftby Apr 2025
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