ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

obesity

metabolic syndrome

diabetes

hypercholesterolaemia

Condition category

Condition code

Diet and Nutrition

Obesity

Metabolic and Endocrine

Metabolic disorders

Metabolic and Endocrine

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]

Lifestyle

Intervention code [2]

Rehabilitation

Intervention code [3]

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]

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]

Baseline, 6 weeks post-intervention commencement.

Primary outcome [2]

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]

Baseline, 6 weeks post-intervention commencement.

Primary outcome [3]

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]

Baseline, 6 weeks post-intervention commencement.

Secondary outcome [1]

Effects of treatment on the levels of average daily energy expenditures over the previous 7 days as primary outcome.

Timepoint [1]