Cold Vest Exposure for Obesity

Overseen By Joeva Barrow, Ph.D., R.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Rockefeller University

Must not be taking: Insulin, Steroids, Weight loss drugs

Disqualifiers: Type I diabetes, Thyroid disease, Cancer, Raynaud's, others

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

Compensation: Varies

Number of Visits: 2

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how wearing a cold vest might activate brown fat, which can burn calories and improve metabolic health in people with obesity. Researchers aim to understand why this process doesn't naturally occur at normal body temperatures and how it might be activated to treat obesity and related conditions. Participants may qualify if they have a BMI over 30, with or without Type II diabetes, or a BMI between 18.5 and 24.9 without diabetes. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new obesity treatments.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescribed medications other than oral contraceptives. Treatments for weight loss or supplements that may alter weight or metabolism are not allowed, but vitamins are okay.

What prior data suggests that cold vest exposure is safe for humans?

Research shows that cold exposure, such as the cold vest treatment, is generally safe. Studies have found that exposure to cold can increase energy expenditure and activate brown fat, which helps combat obesity.

One study found that cold exposure might improve sugar metabolism and lower blood sugar levels, which is particularly beneficial for individuals with conditions like Type II diabetes. Another study suggested that cold exposure might help reduce diabetes-related risks.

Although these studies don't mention specific side effects, the ongoing testing of this method suggests it is considered safe enough for further exploration. However, individual experiences can vary, so consulting a healthcare provider before participating is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cold vest exposure for obesity because it offers a novel method to potentially manage weight by leveraging the body's natural response to cold. Unlike traditional treatments for obesity, which often involve medication or surgery, this approach uses cooling technology to stimulate metabolism and increase calorie burning. Moreover, it's non-invasive and could improve metabolic health by enhancing insulin sensitivity, making it especially promising for individuals with obesity and type II diabetes. This method could offer a more accessible and less intrusive alternative to current options.

What evidence suggests that Cold Vest Exposure could be an effective treatment for obesity?

This trial will investigate the effects of cold exposure using a cold vest on different groups, including those with obesity and Type II diabetes. Research has shown that cold exposure can activate brown fat, which helps burn calories and boost metabolism. Studies also indicate that repeated cold exposure can lower blood sugar and insulin levels, aiding in blood sugar management. One study found that cold exposure might help the body process dietary fats more effectively. This could improve metabolic health for people with obesity or Type II diabetes. While it might not lead to weight loss, cold exposure shows promise in addressing metabolic issues related to obesity. ^{2 5 6 7 8}

Who Is on the Research Team?

Joeva Barrow, Ph.D., R.D.

Principal Investigator

The Rockefeller University and Cornell University

Paul Cohen, Ph.D., M.D.

Principal Investigator

The Rockefeller University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-35 who are either obese with a BMI over 30 and HgA1c levels below 5.7%, or those with Type II diabetes having higher HgA1c levels but possibly on certain medications. A lean group with BMI between 18.5 and 24.9 and low HgA1c is also included.

Inclusion Criteria

I am obese with Type II diabetes, my BMI is over 30, and my HgA1c is above 6.5% or below if I'm on oral diabetes meds.

I am obese with a BMI over 30 and my blood sugar levels are normal.

My BMI is between 18.5 and 24.9, and my HgA1c is below 5.7%.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Nutritional assessments, BMI, and body composition measurements are conducted

1 week

1 visit (in-person)

Cold Exposure and Rewarming

Participants undergo a 3-hour cold exposure followed by a 3-hour rewarming period to assess metabolome, proteome, and transcriptome changes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the cold exposure and rewarming interventions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cold Vest Exposure Period
• Fasting
• Rewarming Exposure Period

Trial Overview The study tests how cold exposure affects the body's ability to generate heat without shivering, which could help treat obesity by activating brown fat thermogenesis—a way our bodies burn calories for warmth.

How Is the Trial Designed?

Group I: Obese group with Type II diabetes Experimental Treatment 3 Interventions

Body Mass Index (BMI) is \> 30, Hemoglobin A1c (HgA1c) is \>6.5%

Group II: Obese group Experimental Treatment 3 Interventions

Body Mass Index (BMI) is \> 30, Hemoglobin A1c (HgA1c) \<5.7%

Group III: Lean group Experimental Treatment 3 Interventions

Body Mass Index (BMI) is between 18.5 and 24.9. Hemoglobin A1c (HgA1c) \<5.7%

Who Is Running the Clinical Trial?

Rockefeller University

Lead Sponsor

Trials

162

Recruited

16,700+

Cornell University

Collaborator

Trials

179

Recruited

14,090,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38203217/

The Effects of Intermittent Cold Exposure on Adipose Tissue While ICE does not consistently lower body weight or fat mass, there does seem to be evidence for ICE as a positive modulator of the metabolic consequences of ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33764169/

Examining the benefits of cold exposure as a therapeutic ... Repeated exposures can lower fasting glucose and insulin levels and improve dietary fatty acid handling, even in healthy individuals. Despite ...

3. journals.physiology.org journals.physiology.org/doi/full/10.1152/japplphysiol.00934.2020?doi=10.1152/japplphysiol.00934.2020

Examining the benefits of cold exposure as a therapeutic ... Repeated exposures can lower fasting glucose and insulin levels and improve dietary fatty acid handling, even in healthy individuals. Despite its apparent ...

4. withpower.com withpower.com/trial/cold-vest-exposure-for-obesity-13403

Cold Vest Exposure for Obesity This trial is for adults aged 18-35 who are either obese with a BMI over 30 and HgA1c levels below 5.7%, or those with Type II diabetes having higher HgA1c ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S266637912300616X

Cold-induced changes in plasma signaling lipids are ... Cold exposure activates brown adipose tissue (BAT) and potentially improves cardiometabolic health through the secretion of signaling lipids by BAT.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9273773/

Effect of Acute Cold Exposure on Energy Metabolism and ... Acute cold exposure could improve the energy expenditure and BAT activity in adults, which is beneficial for human against obesity.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11456273/

Cold Exposure Alleviates T2DM Through Plasma-Derived ... Our data indicate that cold exposure may have a potentially beneficial effect on the development of T2DM, mainly through the anti-diabetic ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01730105

Chronic Cold Exposure and Energy Metabolism in Humans Researchers are studying how metabolism and hormone levels change in response to mild changes in environmental temperature.