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Molecular Landscape of Complex Lifestyle Modification

NCT06954298 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-05-01

No results posted yet for this study

Summary

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.

Conditions

  • Obesity Prevention
  • Obesity
  • Metabolic Disease

Interventions

BEHAVIORAL

supervised lifestyle modification

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

Sponsors & Collaborators

  • Medical University Vienna

    collaborator UNKNOWN

  • Slovak Academy of Sciences

    lead OTHER_GOV

Principal Investigators

  • Barbara Ukropcová, Prof. MD PhD · Biomedical Research Center Slovak Acad Sci

  • Jozef Ukropec, PhD, DSc · Biomedical Research Center Slovak Acad Sci

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-15
Primary Completion
2025-12-31
Completion
2026-06-30

Countries

  • Slovakia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06954298 on ClinicalTrials.gov