Metabolic Flexibility to Predict Lifestyle Interventions Outcomes
NCT ID: NCT06329349
Last Updated: 2024-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-01-02
2026-04-01
Brief Summary
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Detailed Description
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Another potential player predicting an individual's capacity to respond to lifestyle interventions is the gut microbiota (gut microbiome and metabolome, MIME). It was repeatedly shown to be among the most important sources of inter-individual variability when it comes to the development of obesity and responsiveness to dietary intervention The microbiome does not only influence host physiology directly, e.g. through contact with immune cells, but also through the vast array of metabolites produced, i.e. the microbiota-derived metabolome. The composition of the gut microbiota and the microbiota-derived metabolome is largely shaped by the host's diet, as this represents the main source of substances and energy for the microbiota. It is therefore striking that published studies to date have yielded rather inconsistent results regarding dietary interventions to alter gut microbiota composition. The discrepancy can be explained by the large variability of individual microbiomes at the beginning of the intervention, and similarly the baseline MIME signature significantly determines weight loss success.
Here the investigators present a complex project to investigate whether whole body and gut MetFlex can be further explored and used as ex-ante predictors of successful weight loss following exercise and dietary interventions, thus providing proof of concept and paving the way to personalized lifestyle interventions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention
Exercise intervention
Exercise
12 weeks, 3 times a week of progressive endurance aerobic exercise (150 to 400kcal AEE per session)
Combined Exercise + Diet
12 weeks, 25% caloric reduction, based on PMID: 37069434
Control
No intervention.
No interventions assigned to this group
Interventions
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Exercise
12 weeks, 3 times a week of progressive endurance aerobic exercise (150 to 400kcal AEE per session)
Combined Exercise + Diet
12 weeks, 25% caloric reduction, based on PMID: 37069434
Eligibility Criteria
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Inclusion Criteria
* age 25-45 years
Exclusion Criteria
* diabetes (medical history, fasting glycemia \>7.6 and/or 2hOGTT glycemia \>11.1)
* uncontrolled endocrine diseases
* corticosteroid therapy
* immune-suppressive therapy
* pregnancy
* breastfeeding
25 Years
45 Years
FEMALE
Yes
Sponsors
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Ministry of Health, Czech Republic
OTHER_GOV
EXCELES LX22NPO5104, CarDia
UNKNOWN
Charles University, Czech Republic
OTHER
Responsible Party
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Jan Gojda, MD
ass. prof. MD
Principal Investigators
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Jan Gojda
Role: PRINCIPAL_INVESTIGATOR
Third Faculty of Medicine Charles University
Locations
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University Hospital Kralovske Vinohrady
Prague, , Czechia
Third Medical Faculty,Charles University
Prague, , Czechia
Faculty of Sports Science
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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References
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Ludlova M, Koudelkova K, Pallova J, Koudelkova B, Siklova M, Cahova M, Vetrovsky T, Steffl M, Gojda J. Metabolic Flexibility to Predict Lifestyle Interventions Outcomes (MEPHISTO): Protocol for Predictive Validation Study and Randomized Controlled Trial. JMIR Res Protoc. 2025 May 8;14:e67570. doi: 10.2196/67570.
Other Identifiers
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EK VP57/0/2023
Identifier Type: -
Identifier Source: org_study_id
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