Clinical trial NCT05211817: Research on Prevention, Intervention and Mechanisms of Obesity and Its Comorbidities
Official title: Physical Activity and Nutrition Program in the Prevention and Treatment of Obesity, Mechanisms of Obesity and Its Comorbidities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Exercise
Nutrition, Healthy
Lead sponsor: Slovak Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: Medical University of Vienna
First posted: 2022-01-27
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial with complex lifestyle intervention and carnosine supplementation.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Obesity and lack of physical activity are associated with an increased risk of many chronic diseases and accelerate the processes associated with aging. Weight reduction and physical fitness are health benefits of long-term and comprehensive lifestyle modification based on nutritional habits, increased physical activity and psychotherapy. A healthy lifestyle is the basis for the prevention and treatment of obesity. However, conditions for the prescription of physical activity, nutrition and psychotherapy have not been established in our healthcare system. The aim of the project is to determine the effects of a 3-month complex intervention with/without carnosine (including aerobic/strength training, nutritional and psychological counseling) on body composition, physical fitness and circulating biochemical characteristics. Molecular biomarkers can be a very useful diagnostic markers as well as a parameter for monitoring the effectiveness of a complex lifestyle intervention. Long-term follow-up and inclusion in long-term programs will be offered to all study probands who are interested.

Detailed description: Training is combining one 60min session of aerobic training with two 1-hour weekly lessons of aerobic strength training composed of 25 minutes, 60-70% 1RM, training the large muscle groups and 25 minutes of rowing or stationary biking. Starting with warm-up and stretching cool down at the end. The individualized training program will be based on the actual patients physical fitness (VO2max, bicycle spiroergometry) and muscle strength (dynamometry). The training will take place in small groups of 4-5 volunteers. There will be 15-minute breaks for ventilation and surface disinfection between training sessions. All coaches of the Center are vaccinated. The aim is to provide a safe environment for training, in order to increase physical fitness and reduce the weight of obese patients. The center has experience with full-time and online trainings (via the publicly available Facebook BMC SAS as well as through the ZOOM platform) http://www.biomedcentrum.sav.sk/centrum-pohybovej-aktivity/

The nutritional intervention will be carried out by nutrition specialists with the use of individual and group counseling, which enables the individualized dietary prescription. Coaching will take place in person in groups of 5-10 probands (BMC SAS, with a frequency of once a month, in accordance with the current epidemiological situation), resp. by phone / online, with a frequency of once a week.

Psychological counseling will be provided by clinical psychologists. Individual and group form, with a frequency of at least once per month. Psychological counseling will focus on identifying the triggers of inappropriate eating behavior and influencing them, as well as supporting the development of new, healthier habits.

3 months carnosine supplementation (2 g per day) will be provided as described elsewhere.

Eligibility criteria: Inclusion Criteria:

* sedentary men and women (approximately 1:1) aged 25-45 years, BMI 28-38 kg/m2
* absence of chronic diseases and regular pharmacotherapy intake
* capable to complete a training intervention (assessment by a cardiologist)
* signed informed consent
* absence of any psychological, sociological or geographical factors that could jeopardize participation in the study
* Vaccination against SARS-CoV-2 with one of the approved vaccines available in Slovakia (at least 2 weeks after the last dose) and regular PCR testing during the study.

Exclusion Criteria:

* any chronic disease (oncological, cardiovascular, neurological, liver, kidney or other diseases and its acute complications at the discretion of the doctor);
* No cooperation of probands;
* insufficient functional capacity - the presence comorbidities or disorders of the musculoskeletal system, which makes it impossible to complete the training program (assessment by cardiologist, or orthopedist or other specialist);
* smoking, alcohol or drugs abuse;
* non-compliance with epidemiological measures;
* absence of complete vaccination with SARS-CoV-2 vaccine;
* presence of a pacemaker or metal implants (contraindication for magnetic resonance imaging).

Primary outcomes:
measure: Intervention induced change in abdominal adiposity
timeFrame: 3 months
measure: Intervention induced change in VO2max.
timeFrame: 3 months
measure: Intervention induced change in abdominal muscle mass
timeFrame: 3 months
measure: Intervention induced change in muscle strength.
timeFrame: 3 months
measure: Intervention induced change in glucose level and glucose metabolism.
timeFrame: 3 months
measure: Intervention induces change in lipid profile.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: Biomedical Research Center Slovak Academy of Sciences
Study officials:
affiliation: Biomedical Research Centre SAS
name: Barbara Ukropcova, Prof.
role: PRINCIPAL_INVESTIGATOR
References: