NCT06885255

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

Effects of Intermittent Fasting and Its Combination with High-Intensity Interval Training on Inflammatory and Metabolic Markers, As Well As the Microbiome in Patients with Metabolic Syndrome: a Randomized Controlled Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Metabolic Syndrome
• Obesity and Obesity-related Medical Conditions

Interventions

Type	Name	Description
OTHER	Alternate day fasting	Participants are instructed to alternate between consuming 100% of their usual energy intake on one day and only 25% on the following day.
OTHER	Time restricted eating	Subjects are instructed to limit their energy intake to 8 hours a day and to fast for the remaining 16 hours.
OTHER	High-intensity interval training	Patients participate in high-intensity interval training.

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-12-01
• Completion: 2026-03-01
• First posted: 2025-03-20
• Last updated: 2025-03-20

Locations

1 site across 1 country: Germany