Chronic Intermittent Cold Exposure on Weight Loss

Study Overview
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Brief Summary
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To test whether chronic intermittent cold exposure is more effective in programmed body weight loss when compared to conventional programmed weight loss. To measure the metabolic responses (e.g. in the white and brown adipose tissue, muscle and circulating markers) of treatment with chronic intermittent cold exposure and conventional treatment To measure tissue specific changes of weight loss and the treatment with chronic intermittent cold exposure in glucose uptake rate in adipose organ (white and brown adipose tissue), liver, myocardium, skeletal muscle and brain To measure tissue specific biochemical indicators before and after treatment with chronic intermittent cold exposure from white adipose tissue and skeletal muscle. To compare changes in body composition and fat distribution after weight loss using chronic cold exposure or using conventional method

Official Title
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Chronic Intermittent Cold Exposure on Weight Loss

Conditions
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Obesity

Intervention / Treatment
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* Biological: Whole body cryotherapy
* Behavioral: counseling and behavioral therapy for weight loss


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI > 30 (inclusive) Body weight less than 120 kg Weight stability for 3 months Plasma triglyceride concentration less than 3.0 mmol/l Plasma HDL-cholesterol more than 0.9 mmol/l in males and more than 1.0 mmol/l in females Blood pressure less than 140/90 mmHg (inclusive) Normal glucose tolerance or impaired glucose tolerance but not diabetes (fasting glucose < 7.0 mmol/l or 2 h glucose in the oral glucose tolerance test < 11.1 mmol/l) Exclusion Criteria: Smoking Frequent weight loss attempts Pregnancy or lactation Diabetes mellitus Hypo/hyperthyreosis Cardiovascular disease, stroke or neurological disorder Medication (antihypertensive and antidiabetic drugs, lipid lowering drugs, antidepressants, corticosteroids) Claustrophobia Any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results. Presence of any ferromagnetic objects that would make MRI imaging contraindicated

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional weight loss treatment group<br>Eating and physical activity counseling and behavioral therapy for weight loss. | Behavioral: counseling and behavioral therapy for weight loss<br>* Weight loss intervention with Very Low Calory Diet (VLCD, 500-1000 kcal / d + dietary supplements) and group and individual treatment (eating, physical activity counseling and behavioural therapy).<br>|
| Experimental: Cryo group<br>Eating and physical activity counseling and behavioral therapy for weight loss will be provided to all subjects. The subjects in the cryo group will be given whole-body cryotherapy 1-3 times a week for the 4-month-treatment period | Biological: Whole body cryotherapy<br>* Cryotherapy: The whole-cody cryotherapy device (Univers Cryo-Combi;Oy MJG Univers Ab, Helsinki, Finland) consists of 3 chambers set at different temperatures. The first 2 chambers are meant for precooling (-30°Cand-60°C), and the patient remains in these for a very short time. The third chamber temperature reaches -110°C, and the patient remains inside for 3-4 minutes wearing a bathing suit or trunks, acral parts covered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss | Effect of chronic intermittent cold exposure and conventional treatment on weight loss | looking forward using periodic observations collected predominantly during 12 months following subject enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose uptake | Effect of chronic intermittent cold exposure and conventional treatment on glucose uptake of brown and white adipose tissue, liver, myocardium, skeletal muscle and brain (PET-scan). | 4 months from admission | 
| energy metabolism | Effect of chronic intermittent cold exposure and conventional treatment on energy metabolism | 12 months from admission | 
| behavioural patterns | Effect of chronic intermittent cold exposure and conventional treatment on behavioural patterns | 12 months from admission | 
| muscle metabolism | Effect of chronic intermittent cold exposure and conventional treatment on muscle metabolism | 12 months from admission | 
| white adipose tissue metabolism | Effect of chronic intermittent cold exposure and conventional treatment on white adipose tissue metabolism | 12 months from admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight loss, brown adipose tissue, white adipose tissue, muscle, metabolism, cold exposure