ObesityCICENCT01312090
Chronic Intermittent Cold Exposure on Weight Loss
A study testing Whole body cryotherapy and counseling and behavioral therapy for weight loss in people with Obesity, run by Helsinki University Central Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obesity
- What is being tested?
- Whole body cryotherapy and counseling and behavioral therapy for weight loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- Smoking
- Frequent weight loss attempts
- Pregnancy or lactation
- Diabetes mellitus
- Hypo/hyperthyreosis
- Cardiovascular disease, stroke or neurological disorder
Show all 10Show fewer
- 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
About this study
- 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
- Conditions
- Obesity
- Being tested
- Whole body cryotherapy, counseling and behavioral therapy for weight loss
- Keywords
- Weight loss, brown adipose tissue, white adipose tissue, muscle, metabolism, cold exposure
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
counseling and behavioral therapy for weight lossBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Conventional weight loss treatment group | Active comparator | Eating and physical activity counseling and behavioral therapy for weight loss. Receives: 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 Receives: Biological: Whole body cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Effect of chronic intermittent cold exposure and conventional treatment on weight loss
Measured: looking forward using periodic observations collected predominantly during 12 months following subject enrollment
Secondary outcomes (5)
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).
Measured: 4 months from admission
energy metabolism
Effect of chronic intermittent cold exposure and conventional treatment on energy metabolism
Measured: 12 months from admission
behavioural patterns
Effect of chronic intermittent cold exposure and conventional treatment on behavioural patterns
Measured: 12 months from admission
muscle metabolism
Effect of chronic intermittent cold exposure and conventional treatment on muscle metabolism
Measured: 12 months from admission
white adipose tissue metabolism
Effect of chronic intermittent cold exposure and conventional treatment on white adipose tissue metabolism
Measured: 12 months from admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startOct 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital, Novo Nordisk A/S
- Responsible party
- Principal investigator, Sanna Kaye, Helsinki University Central Hospital
- Investigators
- Kirsi H Pietilainen, MD, PhD, Principal investigator, Obesity research Unit, Department of Medicine, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312090
- Sponsor's protocol ID
- PS09RUSRAS
- Other IDs
- T1070RUSRA
- Acronym
- CICE
- Status last verified
- Sep 2012
- First submitted
- 7 Mar 2011
- Last updated
- 6 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 41507695Karppinen 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.
PubMed 40903800van 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.
PubMed 33560372
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Intermittent Cold Exposure on Weight Loss
- ClinicalTrials.gov ID
- NCT01312090
- Acronym / sponsor ID
- CICE / PS09RUSRAS
- Conditions
- Obesity
- Keywords
- Weight loss, brown adipose tissue, white adipose tissue, muscle, metabolism, cold exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Turku University Hospital, Novo Nordisk A/S
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 10 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional weight loss treatment group | Active comparator | Behavioral: counseling and behavioral therapy for weight lossEating and physical activity counseling and behavioral therapy for weight loss. |
| Cryo group | Experimental | Biological: Whole body cryotherapyEating 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- Smoking
- Frequent weight loss attempts
- Pregnancy or lactation
- Diabetes mellitus
- Hypo/hyperthyreosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole body cryotherapyCryotherapy: 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. | Biological | Cryo group |
| counseling and behavioral therapy for weight lossWeight 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). | Behavioural | Conventional weight loss treatment group |
Primary outcome
weight loss
Time frame: looking forward using periodic observations collected predominantly during 12 months following subject enrollment
Effect of chronic intermittent cold exposure and conventional treatment on weight loss
5 secondary outcomes
Glucose uptake
Time frame: 4 months from admission
energy metabolism
Time frame: 12 months from admission
behavioural patterns
Time frame: 12 months from admission
muscle metabolism
Time frame: 12 months from admission
white adipose tissue metabolism
Time frame: 12 months from admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2012.
- Derived from this study: PubMed 41507695van 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.
- Derived from this study: PubMed 40903800Karppinen 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.
- Derived from this study: PubMed 33560372van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsi H Pietilainen, MD, PhD principal investigator
Obesity research Unit, Department of Medicine, Helsinki University Central Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Whole body cryotherapy and counseling and behavioral therapy for weight loss in people with Obesity, run by Helsinki University Central Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight loss (time frame: looking forward using periodic observations collected predominantly during 12 months following subject enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01312090, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2012.