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

University of Erlangen-Nürnberg Medical School250 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

250

Conditions

Metabolic Syndrome Obesity and Obesity-related Medical Conditions

Alternate day fastingOTHER

Participants are instructed to alternate between consuming 100% of their usual energy intake on one day and only 25% on the following day.

Time restricted eatingOTHER

Subjects are instructed to limit their energy intake to 8 hours a day and to fast for the remaining 16 hours.

High-intensity interval trainingOTHER

Patients participate in high-intensity interval training.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Written consent to participate in the study. * Persons aged 18 years and older. * Diagnosis of Metabolic Syndrome (MetS) with elevated hsCRP. Exclusion Criteria: * Pregnant or nursing individuals. * Cardiovascular diseases or orthopedic restrictions that prevent exercise. * Use of medication or supplements that significantly affect study outcomes (e.g., anti-inflammatory medications, antibiotics within the last 6 weeks). * Body weight greater than 200 kg (maximum capacity of training equipment). * Individuals with mental illnesses that may impair their ability to understand or participate in the study.

Locations (1)

Hector-Center for Nutrition, Exercise and Sports, University Hospital Erlangen

Erlangen, Bavaria, Germany

RECRUITING