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Effects of Intermittent Fasting and Exercise on Inflammation, Metabolism, and the Microbiome in Metabolic Syndrome

Study acronym: FIT
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated March 20, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
The goal of this intervention trial is to assess the effects of intermittent fasting, both alone and in combination with high-intensity interval training, on patients with obesity and metabolic syndrome. The main question it aims to answer is: Does intermittent fasting, with or without high-intensity interval training, reduce chronic inflammation in patients with obesity and metabolic syndrome? Participants will follow an intermittent fasting regime for 3 months, with one intervention group additionally participating in high-intensity interval training twice a week. In addition, there are two control groups: one consisting of participants with metabolic syndrome and one consisting of generally healthy individuals. The study includes a 3-month intervention phase followed by a 3-month follow-up phase. During the 6-month study period, all participants will attend 6 in-house study visits and 2 phone visits, during which they will undergo assessments and receive nutritional counseling.
Trial Details
NCT Number NCT06885255
Lead Sponsor University of Erlangen-Nürnberg Medical School
Conditions
(from sponsor)
Metabolic Syndrome, Obesity and Obesity-related Medical Conditions
Related terms Inflammation, Intermittent Fasting, Metabolic Syndrome, Obesity
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov