Metabolic Flexibility to Predict Lifestyle Interventions Outcomes

NCT06329349 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-28

No results posted yet for this study

Summary

Weight loss is a cornerstone of diabetes (T2D) management, yet in clinical practice, its delivery is limited by its perceived burdensome nature and variability in response. Personalization of the interventions to increase their success rate is an unmet clinical need. The proposed project MEPHISTO (Whole body and gut microbiome metabolic flexibility to predict lifestyle intervention outcomes) would aim to identify predictive features related to successful weight loss upon sequential exercise and diet intervention in people living with obesity. To this end, the study aims to conduct a clinical trial where the investigators would implement state-of-the-art physiological phenotyping of metabolic flexibility at the whole-body level and at the level of the gut in persons with obesity before and after exercise and diet + exercise intervention to identify predictive signatures of successful weight loss

Conditions

Interventions

OTHER

Exercise

12 weeks, 3 times a week of progressive endurance aerobic exercise (150 to 400kcal AEE per session)

OTHER

Combined Exercise + Diet

12 weeks, 25% caloric reduction, based on PMID: 37069434

Sponsors & Collaborators

  • Ministry of Health, Czech Republic

    collaborator OTHER_GOV
  • EXCELES LX22NPO5104, CarDia

    collaborator UNKNOWN
  • Charles University, Czech Republic

    lead OTHER

Principal Investigators

  • Jan Gojda · Third Faculty of Medicine Charles University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-02
Primary Completion
2025-12-12
Completion
2026-04-01

Countries

  • Czechia

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 NCT06329349 on ClinicalTrials.gov