CryotherapyNCT04375969

Short to Long Effects of Whole Body Cryostimulation on Insulin Sensitivity Among Overweight

A study testing whole body cryostimulation treatment, Connection WBC treatment and HIIT training and HIIT training group in people with Cryotherapy and Training, run by Gdansk University of Physical Education and Sport at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Cryotherapy, Training, Overweight
What is being tested?: whole body cryostimulation treatment, Connection WBC treatment and HIIT training and HIIT training group
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 sitePoland
Study dates: 3 Jan 2018to 30 Dec 2021
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 20 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

obesity (BMI >30kg/m2),
age >18 years,
diagnosis of impaired glucose tolerance (IGT),
functional autonomy,
ability to discernment,
no WBC treatment within the previous year.

Who cannot join

using insulin or other chronic medications,
inflammatory/immune-mediated pathologies,
T2D,
liver or kidney disease,
cardiovascular diseases,
neuropathy, retinopathy,

Show all 9Show fewer

neoplasia, as well as fragility fractures of bones,
traumatic fractures in the previous 2 years,
contraindications for WBC and exercise

Trial locations and contacts

1 site in 1 country.

Poland1 site

Ziemann Ewa
Sopot, Pomeranian Voivodeship, 81-735

Other trials in Poland

About this study

Official title: Short to Long Effects of Whole Body Cryostimulation on Insulin Sensitivity Among Overweight: Translational Controlled Trial Investigating Coldness and Training Effects on Endocrine Regulation on Energy Metabolism

Therapeutic effectiveness of coldness in relieving pain and reducing inflammation has been known for many years now. Over that time, various coldness therapies have gained in popularity, including winter swimming, snow baths or whole body cryostimulation (WBC) . Recent researches have shown positive effects of WBC on metabolic profile, low-to-moderate chronic inflammation and related diseases (e.g., obesity). WBC could be, thus, intended as an adjuvant method in the treatment of dysmetabolic conditions, such as overweight or obesity. WBC is a cheap easily accessible practice, with a few well-defined contraindications and limited non severe possible adverse events, if performed in specialized centres. At the same time, in sport science appears data, which indicated on inhibition of adaptive changes induced by regular training.

The primary aim is to define, through a randomized controlled approach, the relative effectiveness of up to 20 consecutive sessions of either WBC, high-intensity intermittent training (HIIT), or their combination (WBC and HIIT) in improving the metabolic status of overweight and obese subjects. The effects will be assessed, at different time-points, in terms of insulin sensitivity and modification in the profile of hormones regulating the energy metabolism (adipokines, myokines, bone-derived hormones) and the inter-organ cross-talk.

Read the detailed description

Secondary aims are:

To assess the influence of WBC and HIIT on insulin sensitivity and establish the role of myokines (irisin and IL-6) in this regulation. To find the answer for the question if the rise of mentioned myokines cause a decrease of authophagy protein HMGB1.
To characterize potential effectiveness of these intervention protocols on bone and energy metabolisms by stimulating in vitro cultured normal human osteoblastic primary cells and β-pancreatic cells with sera obtained from patients at different time points during treatment.
To establish, which procedure is most effective at improving insulin sensitivity: training or training supported with WBC treatment, which factors modify this response (body composition or physical capacity of subjects)
To establish if training supported with WBC treatment impairs adaptive changes of trained subjects
To determine the potential beneficial effects of the intervention protocols on the metabolic homeostasis, and assess how long these changes are maintained over a period of four weeks or three months.

Conditions: Cryotherapy, Training, Overweight, Insulin
Being tested: whole body cryostimulation treatment, Connection WBC treatment and HIIT training, Control Group, HIIT training group
Keywords: cold treatment, insulin resistance, HIIT, cell cultures line
Medical subject headings: Overweight, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

whole body cryostimulation treatmentOther
The WBC is apporved by National Ministry of Health. It uses cryochamber with low temperature -110 oC. The patient, minimally dressed (e.g., bathing suit, socks, clogs, headband, and surgical mask), remains 30sec at -60°C (vestibule) for body adaptation and, then, passes to the cryochamber, at -110°C and stay there 3 minutes.
Connection WBC treatment and HIIT trainingOther
WBC combination with Exercise HIIT according to Litlle protocol from 2011. This exercise protocol will be applied together with cryo-sessions
Control GroupOther
This group willnot to change their daily habits . The measurements will be taken at baseline and at the end of the study
HIIT training groupOther
This group will do the training program without cold exposure

Study groups in NCT04375969
Study group	Role	What they receive
whole body cryostimulation treatment	Experimental	WBC will be performed at the Pomeranian Rheumatologic Centre in Sopot. The centre is equipped with an electric cryochamber Zimmer Medicine System, Cryochamber ELECPOL, located in a temperature- and humidity-controlled room. The patient, minimally dressed (e.g., bathing suit, socks, clogs, headband, and surgical mask), remains 30sec at -60°C (vestibule) for body adaptation and, then, passes to the cryochamber, at -110°C and stay there 3 minutes. Receives: Other: whole body cryostimulation treatment
Connection WBC treatment and HIIT training	Experimental	This group will perform HIIT protocol and WBC sessions . HIIT will be performed after 1h WBC. Receives: Other: Connection WBC treatment and HIIT training
Control Group	Active comparator	Control group who will be investigated (meanwhile at baseline and after the interventions) Receives: Other: Control Group
HIIT training group	Experimental	This group will perform only HIIT protocol without cryo-sessions Receives: Other: HIIT training group

What is being measured

The primary outcome is the main question the study is designed to answer.

The assessment of pro- and anti-inflammatory proteins concentration in blood , in response to applied procedures.
Proinflammatory:
HMGB1 ng/ml, CRP ng/ml TNFalpha pg/ml
Anti-inflammaotry:
Irisin ng/ml Adiponectin ng/ml Leptin ng/lm IL-10 pg/ml
Measured: one month

Secondary outcomes (1)

Assessment of insulin sensitivity and insulin resistance
Measurement of fasting glucose and after oral glucose test concentration:
glucose mg/ml insulin ng/ml, calculating Matsuda and HOMA indicators based on glucose and insulin concentrations
Measured: one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jan 201830 Dec 2021

First posted6 May 2020
Study start3 Jan 2018
Primary completion30 Dec 2019
Study completion30 Dec 2021 (estimated)

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 CryotherapyStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: The primary aim is to define, through a randomized controlled approach, the relative effectiveness of up to 10-20 consecutive sessions of either whole body cryostimulation (WBC), high-intensity intermittent training (HIIT), or their combination (WBC and HIIT) in improving the metabolic status of overweight subjects. The effects will be assessed, at different time-points, in terms of insulin sensitivity and modification in the profile of hormones regulating the energy metabolism (adipokines, myokines, bone-derived hormones) and the inter-organ cross-talk.
Masking: Single blind
Who is masked: Participant
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04375969
Sponsor's protocol ID: NCN 2017/25/B/NZ7/02309
Status last verified: May 2021
First submitted: 29 Apr 2020
Last updated: 11 May 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Lombardi G, Ziemann E, Banfi G. Whole-Body Cryotherapy in Athletes: From Therapy to Stimulation. An Updated Review of the Literature. Front Physiol. 2017 May 2;8:258. doi: 10.3389/fphys.2017.00258. eCollection 2017.
PubMed 28512432
Dulian K, Laskowski R, Grzywacz T, Kujach S, Flis DJ, Smaruj M, Ziemann E. The whole body cryostimulation modifies irisin concentration and reduces inflammation in middle aged, obese men. Cryobiology. 2015 Dec;71(3):398-404. doi: 10.1016/j.cryobiol.2015.10.143. Epub 2015 Oct 22.
PubMed 26475491
Ziemann E, Olek RA, Grzywacz T, Kaczor JJ, Antosiewicz J, Skrobot W, Kujach S, Laskowski R. Whole-body cryostimulation as an effective way of reducing exercise-induced inflammation and blood cholesterol in young men. Eur Cytokine Netw. 2014 Mar 1;25(1):14-23. doi: 10.1684/ecn.2014.0349.
PubMed 24998353

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cryotherapy trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Short to Long Effects of Whole Body Cryostimulation on Insulin Sensitivity Among Overweight: Translational Controlled Trial Investigating Coldness and Training Effects on Endocrine Regulation on Energy Metabolism
ClinicalTrials.gov ID: NCT04375969
Acronym / sponsor ID: NCN 2017/25/B/NZ7/02309
Conditions: Cryotherapy, Training, Overweight, Insulin
Keywords: cold treatment, insulin resistance, HIIT, cell cultures line
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 80 participants (estimated)
Lead sponsor: Gdansk University of Physical Education and SportUniversity, hospital or other
Study start: 3 Jan 2018 (actual)
Primary completion: 30 Dec 2019 (actual)
Study completion: 30 Dec 2021 (estimated)
First posted: 6 May 2020 (actual)
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.

Detailed description

Secondary aims are:

To assess the influence of WBC and HIIT on insulin sensitivity and establish the role of myokines (irisin and IL-6) in this regulation. To find the answer for the question if the rise of mentioned myokines cause a decrease of authophagy protein HMGB1.
To characterize potential effectiveness of these intervention protocols on bone and energy metabolisms by stimulating in vitro cultured normal human osteoblastic primary cells and β-pancreatic cells with sera obtained from patients at different time points during treatment.
To establish, which procedure is most effective at improving insulin sensitivity: training or training supported with WBC treatment, which factors modify this response (body composition or physical capacity of subjects)
To establish if training supported with WBC treatment impairs adaptive changes of trained subjects
To determine the potential beneficial effects of the intervention protocols on the metabolic homeostasis, and assess how long these changes are maintained over a period of four weeks or three months.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4
Model description: The primary aim is to define, through a randomized controlled approach, the relative effectiveness of up to 10-20 consecutive sessions of either whole body cryostimulation (WBC), high-intensity intermittent training (HIIT), or their combination (WBC and HIIT) in improving the metabolic status of overweight subjects. The effects will be assessed, at different time-points, in terms of insulin sensitivity and modification in the profile of hormones regulating the energy metabolism (adipokines, myokines, bone-derived hormones) and the inter-organ cross-talk.

Arm	Type	Receives
whole body cryostimulation treatment	Experimental	Other: whole body cryostimulation treatmentWBC will be performed at the Pomeranian Rheumatologic Centre in Sopot. The centre is equipped with an electric cryochamber Zimmer Medicine System, Cryochamber ELECPOL, located in a temperature- and humidity-controlled room. The patient, minimally dressed (e.g., bathing suit, socks, clogs, headband, and surgical mask), remains 30sec at -60°C (vestibule) for body adaptation and, then, passes to the cryochamber, at -110°C and stay there 3 minutes.
Connection WBC treatment and HIIT training	Experimental	Other: Connection WBC treatment and HIIT trainingThis group will perform HIIT protocol and WBC sessions . HIIT will be performed after 1h WBC.
Control Group	Active comparator	Other: Control GroupControl group who will be investigated (meanwhile at baseline and after the interventions)
HIIT training group	Experimental	Other: HIIT training groupThis group will perform only HIIT protocol without cryo-sessions

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

obesity (BMI >30kg/m2),
age >18 years,
diagnosis of impaired glucose tolerance (IGT),
functional autonomy,
ability to discernment,

Key exclusion criteria (9 listed)

using insulin or other chronic medications,
inflammatory/immune-mediated pathologies,
T2D,
liver or kidney disease,
cardiovascular diseases,

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 cryostimulation treatmentThe WBC is apporved by National Ministry of Health. It uses cryochamber with low temperature -110 oC. The patient, minimally dressed (e.g., bathing suit, socks, clogs, headband, and surgical mask), remains 30sec at -60°C (vestibule) for body adaptation and, then, passes to the cryochamber, at -110°C and stay there 3 minutes.	Other	whole body cryostimulation treatment
Connection WBC treatment and HIIT trainingWBC combination with Exercise HIIT according to Litlle protocol from 2011. This exercise protocol will be applied together with cryo-sessions	Other	Connection WBC treatment and HIIT training
Control GroupThis group willnot to change their daily habits . The measurements will be taken at baseline and at the end of the study	Other	Control Group
HIIT training groupThis group will do the training program without cold exposure	Other	HIIT training group

Primary outcome

The assessment of pro- and anti-inflammatory proteins concentration in blood , in response to applied procedures.
Time frame: one month
Proinflammatory: HMGB1 ng/ml, CRP ng/ml TNFalpha pg/ml Anti-inflammaotry: Irisin ng/ml Adiponectin ng/ml Leptin ng/lm IL-10 pg/ml

1 secondary outcome

Assessment of insulin sensitivity and insulin resistance
Time frame: one month

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
Background: PubMed 28512432Lombardi G, Ziemann E, Banfi G. Whole-Body Cryotherapy in Athletes: From Therapy to Stimulation. An Updated Review of the Literature. Front Physiol. 2017 May 2;8:258. doi: 10.3389/fphys.2017.00258. eCollection 2017.
Background: PubMed 26475491Dulian K, Laskowski R, Grzywacz T, Kujach S, Flis DJ, Smaruj M, Ziemann E. The whole body cryostimulation modifies irisin concentration and reduces inflammation in middle aged, obese men. Cryobiology. 2015 Dec;71(3):398-404. doi: 10.1016/j.cryobiol.2015.10.143. Epub 2015 Oct 22.
Background: PubMed 24998353Ziemann E, Olek RA, Grzywacz T, Kaczor JJ, Antosiewicz J, Skrobot W, Kujach S, Laskowski R. Whole-body cryostimulation as an effective way of reducing exercise-induced inflammation and blood cholesterol in young men. Eur Cytokine Netw. 2014 Mar 1;25(1):14-23. doi: 10.1684/ecn.2014.0349.

Related trials for Cryotherapy

Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
RecruitingObservational study
A Study to Evaluate Treating Watery Noses With Cryotherapy in the Clinic Setting. This is Cold Therapy, Freezing the Issues at the Back of the Nose to Ease Symptoms.
Chronic Rhinitis
Not yet recruitingPhase 3
Interest of Cryotherapy in Reducing Pain During Radial Arterial Blood Sampling
Chronic Respiratory Diseases

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.

Ewa Ziemann, Professor principal investigator

Poznan University of Physical Education

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

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?

The assessment of pro- and anti-inflammatory proteins concentration in blood , in response to applied procedures. (time frame: one month). 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 NCT04375969, 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 11 May 2021.