Trial Review

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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] 297541 0
Nil known
Universal Trial Number (UTN)
U1111-1229-2825
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 311754 0
overweight 311936 0
Condition category
Condition code
Metabolic and Endocrine 310378 310378 0 0
Normal metabolism and endocrine development and function
Metabolic and Endocrine 310379 310379 0 0
Metabolic disorders
Diet and Nutrition 310380 310380 0 0
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] 313774 0
Rehabilitation
Intervention code [2] 313775 0
Treatment: Other
Comparator / control treatment
non-obese subjects were comparator group.
Control group
Active

Outcomes
Primary outcome [1] 319256 0
Weight loss in obese subjects determined using by body composition analyzer (bioimpedance method)
Timepoint [1] 319256 0
After 20th cryostimulation.
Secondary outcome [1] 368400 0
Changes of the lipid profile assessed using enzymatic - colorimetric method.
Timepoint [1] 368400 0
Both after 10 and 20 treatments in the cryochamber.
Secondary outcome [2] 368487 0
Changes in concentration of leptin assessed using enzyme-linked immunosorbent assay (Sandwich ELISA).
Timepoint [2] 368487 0
Both after 10 and 20 treatments in the cryochamber.
Secondary outcome [3] 368488 0
Changes in red cell indexes in obese group assessed using fluorescence flow cytometry method.
Timepoint [3] 368488 0
After 10 treatments in the cryochamber.
Secondary outcome [4] 368918 0
Changes in concentration of hemoglobin in obese group assessed using fluorescence flow cytometry method.
Timepoint [4] 368918 0
After 10 treatments in the cryochamber.
Secondary outcome [5] 368919 0
Changes in concentration of hematocrit in obese group assessed using fluorescence flow cytometry method.
Timepoint [5] 368919 0
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
24
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 21315 0
Poland
State/province [1] 21315 0
Malopolska, Cracow

Funding & Sponsors
Funding source category [1] 302098 0
University
Name [1] 302098 0
The Bronislaw Czech Academy of Physical Education in Cracow
Country [1] 302098 0
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] 301927 0
None
Name [1] 301927 0
Address [1] 301927 0
Country [1] 301927 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302777 0
Regional Medical Council
Ethics committee address [1] 302777 0
Ethics committee country [1] 302777 0
Poland
Date submitted for ethics approval [1] 302777 0
26/06/2017
Approval date [1] 302777 0
30/06/2017
Ethics approval number [1] 302777 0
122/KBL/OIL/2017

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91366 0
Mrs Joanna Wyrostek
Address 91366 0
The Bronislaw Czech Academy of Physical Education in Cracow
Al. Jana Pawla II 78, 31-571 Kraków, malopolskie,
Country 91366 0
Poland
Phone 91366 0
+48 782783410
Fax 91366 0
Email 91366 0
[email protected]
Contact person for public queries
Name 91367 0
Joanna Wyrostek
Address 91367 0
The Bronislaw Czech Academy of Physical Education in Cracow
Al. Jana Pawla II 78, 31-571 Kraków, malopolskie,
Country 91367 0
Poland
Phone 91367 0
+48 782783410
Fax 91367 0
Email 91367 0
[email protected]
Contact person for scientific queries
Name 91368 0
Joanna Wyrostek
Address 91368 0
The Bronislaw Czech Academy of Physical Education in Cracow
Al. Jana Pawla II 78, 31-571 Kraków, malopolskie,
Country 91368 0
Poland
Phone 91368 0
+48 782783410
Fax 91368 0
Email 91368 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1466Ethical 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
SourceTitleYear of PublicationDOI
EmbaseBlood pro-oxidant/antioxidant balance in young men with class II obesity after 20 sessions of whole body cryostimulation: a preliminary study.2021https://dx.doi.org/10.1080/13510002.2021.1881328
EmbaseComplex effects of whole body cryostimulation on hematological markers in patients with obesity.2021https://dx.doi.org/10.1371/journal.pone.0249812
N.B. These documents automatically identified may not have been verified by the study sponsor.