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Trial registered on ANZCTR

Registration number

ACTRN12619000524190

Ethics application status

Approved

Date submitted

27/02/2019

Date registered

2/04/2019

Date last updated

2/04/2019

Date data sharing statement initially provided

2/04/2019

Date results provided

2/04/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

The influence of 20 whole body cryostimulation on adipose tissue metabolites and hematological parameters among young and obese men.

Scientific title

The influence of 20 whole body cryostimulation on adipose tissue metabolites and hematological parameters among young and obese men.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1229-2825

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

obesity

overweight

Condition category

Condition code

Metabolic and Endocrine

Normal metabolism and endocrine development and function

Metabolic and Endocrine

Metabolic disorders

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The influence of the whole body cryostimulation on metabolites of adipose tissue, lipid profile and hematological parameters of blood in obese men and normal adipose tissue.

The aim of the study was to assess the effect of systemic cryostimulation on: the profile of selected adipokines secreted in front of the adipose tissue (adipokine, leptin, tumor necrosis factor alfa), the concentration of C-reactive protein, and also haematological blood and lipid profile parameters among, both young obese men and men with normal body mass. Study group was divided into obese and non-obese subjects, depending on the percentage of body fat: obese more than 26% body fat and non-obese men 8-21% body fat. All participants were subjected to 20 sessions of systemic cryostimulation (1 treatment per day, from Monday to Friday, excluding public holidays). The research was carried out at -120 ° C for 2-3 minutes in a cryochamber located in the Malopolskie Centrum Krioterapii in Cracow (the Malopolska Cryotherapy Centre at Al. Pokoju 82 in Cracow). Each cryostimulation treatment was preceded with a 30-second period of adaptation in the vestibule at -60 ° C. In addition, the first treatment in the cryochamber lasted 1.5 minutes, the second - 2 minutes, and the third and each subsequent - 3 minutes. The sessions in the low-temperature chamber were held in the afternoon, with the participation of a physician from the Cryotherapy Center, and the stay in the cryochamber was supervised by a suitably trained employee of the Cryotherapy Centre. The anthropometric measurements were taken from all patients before first and after last the treatment. The concentrations of selected adipokines and inflammation markers, and as well as haematological blood indicators along with the lipid profile were checked before and after the 10th and 20th cryostimulation.

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Other

Comparator / control treatment

non-obese subjects were comparator group.

Control group

Active

Outcomes

Primary outcome [1]

Weight loss in obese subjects determined using by body composition analyzer (bioimpedance method)

Timepoint [1]

After 20th cryostimulation.

Secondary outcome [1]

Changes of the lipid profile assessed using enzymatic - colorimetric method.

Timepoint [1]

Both after 10 and 20 treatments in the cryochamber.

Secondary outcome [2]

Changes in concentration of leptin assessed using enzyme-linked immunosorbent assay (Sandwich ELISA).

Timepoint [2]

Both after 10 and 20 treatments in the cryochamber.

Secondary outcome [3]

Changes in red cell indexes in obese group assessed using fluorescence flow cytometry method.

Timepoint [3]

After 10 treatments in the cryochamber.

Secondary outcome [4]

Changes in concentration of hemoglobin in obese group assessed using fluorescence flow cytometry method.

Timepoint [4]

After 10 treatments in the cryochamber.

Secondary outcome [5]

Changes in concentration of hematocrit in obese group assessed using fluorescence flow cytometry method.

Timepoint [5]

After 10 treatments in the cryochamber.

Eligibility

Key inclusion criteria

age 20-35, males, no contraindications to whole body cryostimulation, medical qualification, normal (8-21%) or increased (>26%) percentage of adipose tissue determined for age and sex

Minimum age

20 Years

Maximum age

35 Years

Sex

Males

Can healthy volunteers participate?

Yes

Key exclusion criteria

cancer, advanced cardio-respiratory diseases, cardiac arrhythmias, previous blocked arteries, hypertension (>160/100 mmHg), transient ischaemic attacks, improper operation of the thyroid, diabetes, cold intolerance, frostbite, skin damage, kidney, liver or bladder disease, stroke, claustrophobia, smoking, total cholesterol (>300 mg/dL), weight-reducing diet, taking anti-inflammatory drugs.

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Statistical analysis and interpretation of the recorded results was performed using Microsoft Excel 2007 (MS Office) oraz STATITICA 13.1 (StatSoft Poland). For the measured parameters, mean, standard deviation, median, minimum value and maximum was calculated. The normality of the distribution was verified using the Shapiro-Wilk test, which showed no normal distribution for the analyzed indicators. according to
with the above and due to the small size of the studied groups, nonparametric tests were used to analyze all indicators. To assess the significance of differences in mean values within the group, the Wilcoxon pair order test was used. The U-Mann-Whitney test was used to assess the significance between the groups. To determine the correlation between the selected indicators, the Spearman correlation coefficient was used. For all tests, differences and correlation coefficients were assumed to be statistically significant for the significance level of p <0.05

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

5/03/2018

Date of last participant enrolment

Anticipated

Actual

27/04/2018

Date of last data collection

Anticipated

Actual

17/09/2018

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Malopolska, Cracow

Funding & Sponsors

Funding source category [1]

University

Name [1]

The Bronislaw Czech Academy of Physical Education in Cracow

Address [1]

Al. Jana Pawla II 78, 31-571 Kraków, malopolskie

Country [1]

Poland

Primary sponsor type

University

Name

The Bronislaw Czech Academy of Physical Education in Cracow

Address

Al. Jana Pawla II 78, 31-571 Kraków, malopolskie

Country

Poland

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Regional Medical Council

Ethics committee address [1]

Krupnicza 11A, 31-123 Cracow

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

26/06/2017

Approval date [1]

30/06/2017

Ethics approval number [1]

122/KBL/OIL/2017

Summary

Brief summary

Obesity is counted as one of civilization’s most significant diseases. It is a serious 21st century problem in both middle and highly developed countries, and the percentage of people struggling with excess weight is on the increase. Nutritionists and doctors alike are raising the alarm because this phenomenon affects both adults and children. This is exceptionally worrying for society at large.  Therefore, research on adipose tissue activity has gained a new dimension and is fast becoming a crucial area of research for human health. Studies from recent years prove that adipose tissue does not only control homeostasis but also has endocrine functions. The excessive adipose tissue results in an increase in the volume of adipocytes, which is the result of the impaired adipokine secretion. What is also typical, is the disrupted lipid homeostasis and thus a greater susceptibility to metabolic and cardiovascular diseases. Increasingly, the systemic cryostimulation is perceived as one of the potential methods which can affect both the pace of the metabolic rate and the series of biochemical reactions which occur in the adipose tissue. The available scientific sources do not provide unambiguous answers to the questions related to the impact of systemic cryostimulation on the adipokine secretion profile, especially among obese people. The aim of the study  was to assess the effect of 20 systemic cryostimulation on: the profile of selected adipokines secreted in front of the adipose tissue, the concentration of  C-reactive protein, and also haematological blood and lipid profile parameters among, both young obese men and men with normal body mass.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mrs Joanna Wyrostek

Address

The Bronislaw Czech Academy of Physical Education in Cracow
Al. Jana Pawla II 78, 31-571 Kraków, malopolskie,

Country

Poland

Phone

+48 782783410

Fax

joanna.wyrostek1@gmail.com

Contact person for public queries

Name

Joanna Wyrostek

Address

The Bronislaw Czech Academy of Physical Education in Cracow
Al. Jana Pawla II 78, 31-571 Kraków, malopolskie,

Country

Poland

Phone

+48 782783410

Fax

joanna.wyrostek1@gmail.com

Contact person for scientific queries

Name

Joanna Wyrostek

Address

The Bronislaw Czech Academy of Physical Education in Cracow
Al. Jana Pawla II 78, 31-571 Kraków, malopolskie,

Country

Poland

Phone

+48 782783410

Fax

joanna.wyrostek1@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1466	Ethical approval					377077-(Uploaded-27-02-2019-00-37-10)-Study-related document.jpg

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Blood pro-oxidant/antioxidant balance in young men with class II obesity after 20 sessions of whole body cryostimulation: a preliminary study.	2021	https://dx.doi.org/10.1080/13510002.2021.1881328
Embase	Complex effects of whole body cryostimulation on hematological markers in patients with obesity.	2021	https://dx.doi.org/10.1371/journal.pone.0249812

N.B. These documents automatically identified may not have been verified by the study sponsor.

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