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Trial registered on ANZCTR


Registration number
ACTRN12624000184572
Ethics application status
Approved
Date submitted
6/11/2023
Date registered
26/02/2024
Date last updated
26/02/2024
Date data sharing statement initially provided
26/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of physical activity and dietary interventions on body composition, hormones concentration and biochemical blood parameters in males with abdominal obesity
Scientific title
Effect of physical activity and dietary interventions on body composition, adipokines concentration and indicators of lipid and carbohydrate metabolism in males with abdominal obesity
Secondary ID [1] 310885 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 331935 0
metabolic syndrome 331936 0
diabetes 331937 0
hypercholesterolaemia 331938 0
Condition category
Condition code
Diet and Nutrition 328662 328662 0 0
Obesity
Metabolic and Endocrine 328663 328663 0 0
Metabolic disorders
Metabolic and Endocrine 329145 329145 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of the project is to assess the effect of a six-week of: (1) aerobic-resistance physical activity (PA group, intervention arm 1) and (2) a physical activity combined with dietary intervention involving a high-protein diet with low glycemic index carbohydrates (PAD group, intervention arm 2) on body composition, the levels of selected adipokines, and the characteristics of carbohydrate and lipid metabolism parameters in men with abdominal obesity, as compared to men with abdominal obesity who did not participate in the intervention (control group, CG).

The physical activity intervention will take place in a Fitness Club in Cracow under supervision of a personal coach. Planning and monitoring the intensity in the aerobic training as well as amount of load in the resistance training will be set individually based on guidelines of the American College of Sports Medicine (1995). Intensity of the training will be monitored through pulse with the system of Polar M200 GPS Running Watch with Wrist-Based Heart Monitor. Whereas, before the resistance training, the participants will take the test of one-rep max (1RM) which is considered to be a gold standard for assessment of muscles force in non-laboratory situations.
Planned course of the aerobic-resistance training:
The aerobic-resistance intervention will take place 3 times per week, in groups no more than 5. The training will start with a 5-min aerobic warm-up (walking on a treadmill to reach an intensity of 50% HR max). Initially it will comprise 3 complex exercises, such as sit-ups, regular or supported, push-ups with adjustable height of arm prop, bent isolated one-arm dumbbell row, 4 series. Following the adaptation of the body to the training, the intensity will include 3 series of 9 exercises, with 60-sec breaks between them. At first the loads will be set at 50% of 1RM, after 4 weeks it will rise to 70%. After resistance exercises, the participants will train on an exercise bike, x-trainer or treadmill at intensity of 70% HR max. The duration of resistance training during each session will be 25 minutes, followed by 20 minutes of aerobic training. Training will finish with stretching the engaged muscles groups (10 min). The duration of the whole training will be 60 min. It will engage large muscles groups, whereas in subsequent exercises, through isolation of the practised exercises position, the synergistic muscles of lower mass will be activated. The training will employ dumbbells, barbells, training devices, own body mass.
All of the trainings will be carried out at the same time of day (in the afternoon) by the same, qualified a personal coach (with minimum 5 years' experience), in a room with the same temperature and humidity.
The dietary intervention will be based on a high-protein diet (25% of energy requirements) , using carbohydrates with a low glycemic index. The main source of energy will be carbohydrates with a low glycemic index: low-energy vegetables and fruits, whole grain products. The second dominant nutrient in the diet of the respondents will be proteins and their animal sources, i.e. low-fat dairy products, lean meat and lean fish. The "shopping mall" method will be used. In accordance with the assumptions of this method the respondents will make purchases in designated chain stores where the type and quality of products are very similar (deliveries from the same wholesaler). Before culinary processing, study participants will weigh raw products on an electronic scale. The respondents will enter the consumed products into the diet program installed in the application on their phone, where they will receive a report of calories and nutrients consumed. A qualified dietitian will check the program report and send feedback to the respondents on the implementation of the assumed diet parameters.
Each volunteer will be qualified by a physician before participation in the study. The session attendance checklists will be used to monitor adherence to the intervention. The therapy will take place at Fitness Club in Cracow, Poland and will be supervised by the members of the University of Physical Education in Krakow, Poland.
Intervention code [1] 327304 0
Lifestyle
Intervention code [2] 327305 0
Rehabilitation
Intervention code [3] 327306 0
Treatment: Other
Comparator / control treatment
A group without interventions: the participants in the control group will not receive any treatments during this study and will be asked not to alter their nutritional habits, taken medicines, or level of physical activity during the experiment.
Control group
Active

Outcomes
Primary outcome [1] 336486 0
Influence of treatment on the body composition (fat free mass (FFM) (kg), body fat mass (BF) (kg), percentage of body fat (BF) (%), android body fat (AND)(%), gynoid body fat (GYN) (%), body mass index (BMI) (kg/m2), body mineral density (BMD) (g/cm2)) as the composite primary outcome.
Timepoint [1] 336486 0
Baseline, 6 weeks post-intervention commencement.
Primary outcome [2] 336487 0
Influence of treatment on the levels of human hormones (leptin (ng/ml), asprosin (ng/ml), irisin (ng/ml), adiponectin (ng/ml), omentin (ng/ml), IL-6 (ng/ml) and IL-8 (ng/ml)) as the composite primary outcome.
Timepoint [2] 336487 0
Baseline, 6 weeks post-intervention commencement.
Primary outcome [3] 336488 0
Influence of treatment on the levels of indicators of carbohydrate-lipid metabolism (glucose (mmol/L),
insulin (µIU/mL),
total cholesterol (mmol/L), low-density lipoprotein cholesterol (mmol/L), high-density lipoprotein cholesterol (mmol/L), non-HDL cholesterol (mmol/L), triglycerides (mmol/L),
C-reactive protein (hsCRP) (mg/dl) as the composite primary outcome.
Timepoint [3] 336488 0
Baseline, 6 weeks post-intervention commencement.
Secondary outcome [1] 428545 0
Effects of treatment on the levels of average daily energy expenditures over the previous 7 days as primary outcome.
Timepoint [1] 428545 0
Baseline, 6 weeks post-intervention commencement as primary timepoint.
Secondary outcome [2] 428546 0
Effects of treatment on the level of dietary caloric intake assessed as kcal/day as primary outcome.
Timepoint [2] 428546 0
Baseline, 6 weeks post-intervention commencement as primary timepoint.
Secondary outcome [3] 432102 0
Effects of treatment on the heart rate as primary outcome.
Timepoint [3] 432102 0
Baseline, 6 weeks post-intervention commencement as primary timepoint.
Secondary outcome [4] 432103 0
Effects of treatment on the non-exercise activity thermogenesis as primary outcome.
Timepoint [4] 432103 0
Baseline, 6 weeks post-intervention commencement as primary timepoint.
Secondary outcome [5] 432104 0
Effects of treatment on the total energy expenditure (TEE) as primary outcome.
Timepoint [5] 432104 0
Baseline, 6 weeks post-intervention commencement as primary timepoint.

Eligibility
Key inclusion criteria
male sex, age 30-40 years, medical statement on lack of contraindications to take up health training of aerobic-resistance character, written consent for voluntary participation in the research project, increased waist circumference greater than or equal to 94 cm and two criteria out of the following: concentration of triglycerides greater than 150 mg/dl (1.7 mmol/l) or treated hyper-triglyceridemia; concentration of HDL C less than 40 mg/dl (1.03 mmol/l) – in males or treating the lipid disorder; blood pressure systolic (SBP) greater than or equal to 130 mm Hg or diastolic (DBP) greater than or equal to 85 mm Hg, or treatment of a formerly diagnosed hypertension; glucose level in plasma on empty stomach greater than or equal to 100 mg/dl (5.6 mmol/) or pharmacological treatment of type 2 diabetes (T2DM).
Minimum age
30 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
no medical statement on lack of contraindications to take up health training of aerobic-resistance character, unwillingness to continue the intervention (lack of more than 10% of training sessions), unstable ischaemia, decompensated heart failure, uncontrolled heart rhythm disorders, severe pulmonary hypertension (mean blood pressure in lungs > 55 mm Hg), symptomatic aortic stenosis, acute myocarditis, endocarditis or pericarditis, uncontrolled blood pressure (> 180/110 mm Hg), aortic dissection, Marfan syndrome, uncontrolled diabetes, mental disorders, health problems (orthopaedic, neurologic) preventing movement, participation in another form of physical activity during the project, lack of written consent to take part in the examination.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The distribution of results for the analyzed variables will be checked by applying a
Shapiro–Wilk test. For single measurements, the significance of group-related differences
will be assessed using independent-sample tests, Student’s t-test or the Kruskal-Wallis
test. In the examined and control groups for comparing the impact of intervention on changes in the analyzed variables analysis of variance with repeated measures will be used for variables of normal distribution and Friedman test for variables of skewed distribution with post hoc comparison. The statistical significance of differences
was assumed for a level of p < 0.05. The STATISTICA 13 package (StatSoft, Inc., Tulsa, OK,
USA) was used for calculations.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/02/2022
Date of last participant enrolment
Anticipated
Actual
30/05/2022
Date of last data collection
Anticipated
Actual
18/07/2022
Sample size
Target
60
Accrual to date
Final
44
Recruitment outside Australia
Country [1] 25949 0
Poland
State/province [1] 25949 0

Funding & Sponsors
Funding source category [1] 315143 0
University
Name [1] 315143 0
University of Physical Education in Kraków, Poland
Country [1] 315143 0
Poland
Primary sponsor type
Individual
Name
Agnieszka Suder
Address
Institute of Basic Science, Department of Anatomy, al. Jana Pawla II 78 30-245 Kraków
Country
Poland
Secondary sponsor category [1] 317163 0
Individual
Name [1] 317163 0
Karol Makiel
Address [1] 317163 0
Institute of Basic Science, Department of Anatomy, al. Jana Pawla II 78 30-245 Kraków
Country [1] 317163 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314081 0
The Ethical Commitee of Regional Medical Chamber in Krakow
Ethics committee address [1] 314081 0
Ethics committee country [1] 314081 0
Poland
Date submitted for ethics approval [1] 314081 0
17/01/2022
Approval date [1] 314081 0
11/02/2022
Ethics approval number [1] 314081 0
15/KBL/OIL/2022

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

Contacts
Principal investigator
Name 130342 0
Prof Agnieszka Suder
Address 130342 0
Institute of Basic Science, Department of Anatomy al. Jana Pawla II 78 30-245 Kraków
Country 130342 0
Poland
Phone 130342 0
+48126831329
Fax 130342 0
Email 130342 0
agnieszka.suder@awf.krakow.pl
Contact person for public queries
Name 130343 0
Karol Makiel
Address 130343 0
Institute of Basic Science, Department of Anatomy al. Jana Pawla II 78 30-245 Kraków
Country 130343 0
Poland
Phone 130343 0
+4812681159
Fax 130343 0
Email 130343 0
karol.makiel@gmail.com
Contact person for scientific queries
Name 130344 0
Agnieszka Suder
Address 130344 0
Institute of Basic Science, Department of Anatomy al. Jana Pawla II 78 30-245 Kraków
Country 130344 0
Poland
Phone 130344 0
+48126831329
Fax 130344 0
Email 130344 0
agnieszka.suder@awf.krakow.pl

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?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.