NCT01312090

Brief Summary

  1. 1.To test whether chronic intermittent cold exposure is more effective in programmed body weight loss when compared to conventional programmed weight loss.
  2. 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. 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. 4.To measure tissue specific biochemical indicators before and after treatment with chronic intermittent cold exposure from white adipose tissue and skeletal muscle.
  5. 5.To compare changes in body composition and fat distribution after weight loss using chronic cold exposure or using conventional method

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Oct 2010

Shorter than P25 for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

September 6, 2012

Status Verified

September 1, 2012

Enrollment Period

8 months

First QC Date

March 7, 2011

Last Update Submit

September 5, 2012

Conditions

Obesity

Keywords

Weight lossbrown adipose tissuewhite adipose tissuemuscle, metabolismcold exposure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Glucose uptake

    4 months from admission

  • energy metabolism

    12 months from admission

  • behavioural patterns

    12 months from admission

  • muscle metabolism

    12 months from admission

  • white adipose tissue metabolism

    12 months from admission

Study Arms (2)

Conventional weight loss treatment group

ACTIVE COMPARATOR

Eating and physical activity counseling and behavioral therapy for weight loss.

Behavioral: counseling and behavioral therapy for weight loss

Cryo group

EXPERIMENTAL

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

Interventions

Whole body cryotherapyBIOLOGICAL

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.

Cryo group
counseling and behavioral therapy for weight lossBEHAVIORAL

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).

Conventional weight loss treatment group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • van der Kolk BW, Heinonen S, White JW, Wagner A, Karppinen JE, Saari S, Muniandy M, Metsikko S, Dillon ET, Groop PH, Saarinen T, Le Roux CW, Virtanen KA, Docherty NG, Pirinen E, Juuti A, Pietilainen KH. Human Skeletal Muscle Mitochondria Responses to Weight Loss Induced by Bariatric Surgery or Lifestyle Intervention. Acta Physiol (Oxf). 2026 Feb;242(2):e70150. doi: 10.1111/apha.70150.

    PMID: 41507695DERIVED

  • 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 Nov;33(11):2112-2127. doi: 10.1002/oby.70019. Epub 2025 Sep 3.

    PMID: 40903800DERIVED

  • 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.

    PMID: 33560372DERIVED

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

CounselingBehavior Therapy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPsychotherapy

Study Officials

  • Kirsi H Pietilainen, MD, PhD

    Obesity research Unit, Department of Medicine, Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 7, 2011

First Posted

March 10, 2011

Study Start

October 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

September 6, 2012

Record last verified: 2012-09