Cooling Vest Procedure and Fasting overnight for Healthy Lifestyle

Overseen By Kaja Plucinska, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Rockefeller University

Must not be taking: Prescribed medications, Weight loss treatments

Disqualifiers: Diabetes, Thyroid disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how activating brown fat can improve metabolism and overall health. Participants will wear a cooling vest to activate brown fat, and results will be compared with those who simply fast overnight. The goal is to identify blood markers that indicate brown fat activity, potentially leading to easier predictions of metabolic health. Individuals with a BMI between 19 and 25, who do not have conditions like diabetes or thyroid issues, may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on metabolic health.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescribed medications other than oral contraceptives to participate in this trial.

What prior data suggests that the cooling vest procedure and fasting overnight are safe?

Research has shown that cooling vests are generally safe for use. Designed to lower body temperature, these vests can be very helpful in hot weather. People often use them in warm conditions to stay comfortable and prevent overheating. Although specific safety information about using cooling vests to activate brown fat is lacking, their widespread use suggests they are well-tolerated.

Fasting, or not eating for a short period like overnight, is also common and generally safe. Participants should pay attention to how their body feels when fasting. If dizziness or discomfort occurs, they should inform the study team.

Overall, both cooling vests and fasting appear safe based on their use in other situations. Participants should always report any discomfort to the study team during these procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how cooling vests and overnight fasting might influence a healthy lifestyle in unique ways. The cooling vest procedure is intriguing because it leverages the body's natural response to cold—muscle shivering—to potentially boost metabolism without exercise. This method is different from standard lifestyle interventions like diet and exercise, as it focuses on skeletal thermogenesis to generate heat and potentially impact energy expenditure. Meanwhile, the fasting protocol aims to examine the effects of prolonged fasting on blood analytes, which could offer insights into metabolic health without dietary changes. Together, these approaches could open new avenues for maintaining a healthy lifestyle by leveraging natural bodily processes.

What evidence suggests that the cooling vest procedure and fasting overnight could be effective for activating brown fat?

Research shows that brown fat, a special type of body fat, burns calories to create heat when the body is cold. Studies in both mice and humans suggest that activating brown fat can boost metabolism and improve heart health. In this trial, participants in the "Cold Exposure" arm will use cooling vests to lower body temperature and activate brown fat. These vests have reduced heart rate and heat stress, indicating their effectiveness in activating this fat. Early findings suggest that active brown fat releases substances that help control blood sugar and improve muscle and liver function. This makes cooling vests a potential method to enhance metabolic health by activating brown fat and releasing these beneficial substances. ^{6 7 8 9 10}

Who Is on the Research Team?

Kaja Plucinska, PhD

Principal Investigator

The Rockefeller University

Paul Cohen, PhD

Principal Investigator

The Rockefeller University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cold Exposure

Participants undergo a cold exposure procedure with a cooling vest to activate brown fat, with blood draws before and after the procedure

3 hours

1 visit (in-person)

Fasted Procedure

Participants undergo a fasting procedure without cooling to serve as a comparator, with blood draws before and after the fasting period

15 hours

1 visit (in-person)

Follow-up

Participants are monitored for changes in metabolic markers post-procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cooling Vest Procedure
• Fasting overnight

Trial Overview 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.

How Is the Trial Designed?

Group I: Cold Exposure Experimental Treatment 1 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 cooling Active Control 1 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.

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9952803/

Is the Cooling Vest an Ergogenic Tool for Physically Active ... Cooling has been reported to allow the delayed onset of sweating at higher exercise intensities, reducing HR with lower Tsk [43]. Our meta-analysis results show ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S030645652200256X

Efficacy of cooling vests based on different heat-extraction ... Results: The use of the vests attenuated the increase in HR (103 ± 12 bpm) when compared to control trial (116 ± 17 bpm, p < 0.05). Four vests maintained a ...

3. sph.uth.edu sph.uth.edu/news/story/researchers-evaluate-most-effective-methods-of-preventing-heat-stress-and-illness-in-workers

Researchers Evaluate Most Effective Methods of Preventing ... Preliminary results show that cooling vests effectively reduced both heat strain as measured by the monitor's HRV and by a change in the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12299794/

Effects of a Cooling Vest on Core and Skin Temperatures ... The results of this study indicate that using a cool vest for 15 min after a simulated running football protocol on a treadmill changes the Ts ...

5. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1408591/full

Effects of cooling vest and personal protective equipment ... While many studies in the literature have reported that cooling vests effectively decrease heat strain and increase tolerance time (8, 19, 20, ...

6. techniche-intl.com techniche-intl.com/perch/resources/documents/material-safety-data-sheet-h2o-inserts.pdf

MATERIAL SAFETY DATA SHEET The above information is, in part, based on material safety data sheets supplied by the vendor of the raw materials used in these products.

7. techniche-europe.com techniche-europe.com/perch/resources/science/msds-techkewl-cool-pax-2012.pdf

MATERIAL SAFETY DATA SHEET Emergency and First Aid Procedures: Remove from area to fresh air. Remove contaminated clothing. Wash effected areas with soap and warm water. Routes of Entry:.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6997718/

Effectiveness of a field-type liquid cooling vest for reducing ... This study examined the effectiveness of a field-type liquid cooling vest (LCV) worn underneath an impermeable protective suit on heat strain during walking.

9. hmark.com hmark.com/product/cool-aids-hybrid-cooling-vest/

Cool Aids Hybrid Cooling Vest - Protective Equipment Manufactured from polypropylene, this Tray with Cover is designed for safe scope transportation from storage to the procedure room and from the procedure room ...

10. researchgate.net researchgate.net/publication/11426958_A_Cooling_Vest_for_Working_Comfortably_in_a_Moderately_Hot_Environment

(PDF) A Cooling Vest for Working Comfortably in a ... To alleviate worker's thermal discomfort in a moderately hot environment, a new cooling vest was designed and proposed in this paper.