Clinical trial

Molecular Landscape of Complex Lifestyle Modification

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06954298

Active, not recruitingNot applicableInterventional

What this study is about

The goal of this clinical trial is to detect the impact of the 3-month complex lifestyle intervention, consisting of dietary counselling, supervised exercise training and cognitive-behavioural intervention in middle-aged sedentary individuals with obesity, specific questions are: * What is the adaptive response to exercise training on the whole-body and skeletal muscle energy metabolism, insulin sensitivity, metabolic flexibility, muscle functional parameters and cardiopulmonary fitness? * Would the intensity-related changes of the exercise-induced substrate preference (lipids vs carbohydrates) be a good predictive marker of metabolic flexibility i.e. the capacity to reduce the whole-body metabolic burden in patients with obesity? * Is the signal driving the adaptive response to regular exercise contained in serum derived Extracellular vesicles? Researchers will examine effects of exercise training intervention on whole body energy metabolism, by integrating clinical, biochemical and molecular data. Participants will: * Undergo 3 months exercise - intervention program. * Be submitted to examination of their obesity, energy metabolism and cardiopulmonary fitness related phenotypes using bioelectric impedance, indirect calorimetry, cycle spiroergometry. * Blood samples will be taken both, at the baseline PRE- and POST- intervention.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 50 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity Prevention, Obesity, Metabolic Disease

Full registry criteria

Inclusion Criteria: BMI 30-45 kg.m-2 - Exclusion Criteria: smoking, cancer, \-

Treatments and study arms

supervised lifestyle modification

Behavioral

Supervised lifestyle intervention will consist of regular exercise (3x a week), nutritional counselling (weekly), cognitive bahavioural therapy (monthly).

Primary outcomes

Metabolic flexibility in response to submaximal exercise and nutritional challenge24 months

Metabolic flexibility (metabolic substrate switching) will be measured using indirect calorimetry during submaximal exercise test (on stationary bike) and in response to nutritional challenge (fasting / glucose uptake during oGTT)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Center for Obesity Management EASO, Biomedical Research Center SAS🌐 Bratislava, Bratislava Region, Slovakia

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