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

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.

NCT Number	NCT06885255
Lead Sponsor	University of Erlangen-Nürnberg Medical School
Conditions	Metabolic Syndrome, Obesity and Obesity-related Medical Conditions
Enrollment	250 participants
Start Date	2023-06-01
Primary Completion	2025-12 (estimated)
Study Completion	2026-03 (estimated)
Updated on ClinicalTrials.gov	2025-03-20