Chronic Intermittent Cold Exposure on Weight Loss (CICE)

1. To test whether chronic intermittent cold exposure is more effective in programmed body weight loss when compared to conventional programmed weight loss.
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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: counseling and behavioral therapy for weight loss; Biological: Whole body cryotherapy

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional weight loss treatment group; Eating and physical activity counseling and behavioral therapy for weight loss.	Behavioral: 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).
Experimental: 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	Biological: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: Turku University Hospital; Novo Nordisk A/S
• Investigators: Principal Investigator: Kirsi H Pietilainen, MD, PhD, Obesity research Unit, Department of Medicine, Helsinki University Central Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: March 7, 2011
• First Submitted That Met QC Criteria: March 9, 2011
• First Posted (Estimate): March 10, 2011

Study Record Updates

• Last Update Posted (Estimate): September 6, 2012
• Last Update Submitted That Met QC Criteria: September 5, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Weight loss; brown adipose tissue; cold exposure; white adipose tissue; muscle, metabolism
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: PS09RUSRAS; T1070RUSRA (Other Identifier: Helsinki University Central Hospital registry)