Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2010-10-31
2011-06-30
Brief Summary
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2. 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
3. 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
4. To measure tissue specific biochemical indicators before and after treatment with chronic intermittent cold exposure from white adipose tissue and skeletal muscle.
5. To compare changes in body composition and fat distribution after weight loss using chronic cold exposure or using conventional method
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Conventional weight loss treatment group
Eating and physical activity counseling and behavioral therapy for weight loss.
counseling and behavioral therapy for weight loss
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).
Cryo group
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
Whole body cryotherapy
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.
Interventions
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Whole body cryotherapy
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.
counseling and behavioral therapy for weight loss
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
No
Sponsors
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Turku University Hospital
OTHER_GOV
Novo Nordisk A/S
INDUSTRY
Helsinki University Central Hospital
OTHER
Responsible Party
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Sanna Kaye
MD
Principal Investigators
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Kirsi H Pietilainen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Obesity research Unit, Department of Medicine, Helsinki University Central Hospital
References
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Karppinen JE, Suojanen L, Heinonen S, Kaye S, van der Kolk BW, White JW, Orava J, Lee SHT, Dillon E, Muniandy M, Rissanen A, le Roux CW, Docherty N, Pajukanta P, Virtanen KA, Pietilainen KH. Effects of Whole-Body Cryotherapy Combined With Conventional Obesity Management Versus Obesity Management Alone: A Clinical Trial. Obesity (Silver Spring). 2025 Sep 3. doi: 10.1002/oby.70019. Online ahead of print.
van der Kolk BW, Muniandy M, Kaminska D, Alvarez M, Ko A, Miao Z, Valsesia A, Langin D, Vaittinen M, Paakkonen M, Jokinen R, Kaye S, Heinonen S, Virtanen KA, Andersson DP, Mannisto V, Saris WH, Astrup A, Ryden M, Blaak EE, Pajukanta P, Pihlajamaki J, Pietilainen KH. Differential Mitochondrial Gene Expression in Adipose Tissue Following Weight Loss Induced by Diet or Bariatric Surgery. J Clin Endocrinol Metab. 2021 Apr 23;106(5):1312-1324. doi: 10.1210/clinem/dgab072.
Other Identifiers
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T1070RUSRA
Identifier Type: OTHER
Identifier Source: secondary_id
PS09RUSRAS
Identifier Type: -
Identifier Source: org_study_id