NCT05211817

Research on Prevention, Intervention and Mechanisms of Obesity and Its Comorbidities

Physical Activity and Nutrition Program in the Prevention and Treatment of Obesity, Mechanisms of Obesity and Its Comorbidities

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Slovak Academy of Sciences · Other Government
• Sex: All
• Age: 25 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Exercise
• Nutrition, Healthy

Interventions

Type	Name	Description
BEHAVIORAL	Complex lifestyle intervention	Volunteers will undergo a 3-month comprehensive lifestyle modification, consisting of a combined aerobic-strength training intervention, nutritional and psychological counseling. Regular examinations (body weight, waist circumference, body composition by bioimpedance) will be performed every week. Probands in the intervention and control groups will have the opportunity to participate in a long-term program of physical activity at BMC SAS after the end of the study.
DIETARY_SUPPLEMENT	Carnosine	3 months carnosine supplementation (2 g per day) will be given in parallel with a complex lifestyle modification. Carnosine is a dipeptide of beta-alanyl l-histidine, which is found in skeletal muscle and in certain areas of the brain. It is a well-tolerated and approved food supplement in Slovakia. Scientists have extensive experience with the administration of carnosine (deCourten, Ukropcová et al, Obesity 2015 https://doi.org/10.1002/oby.21434; Schon, Ukropcova et al, 2019 DOI: 10.3390 / nu11061196 and others). Carnosine has the potential to positively affect glucose metabolism, and improve the adaptive response to exercise training interventions.

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-06-30
• Completion: 2023-12-31
• First posted: 2022-01-27
• Last updated: 2022-01-27

Locations

1 site across 1 country: Slovakia