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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Erlangen-Nürnberg Medical School

About this trial

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.

Eligibility criteria

Qualifiers

Written consent to participate in the study.

Persons aged 18 years and older.

Diagnosis of Metabolic Syndrome (MetS) with elevated hsCRP.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Alternate day fasting
  • Time restricted eating
  • High-intensity interval training

Treatment groups

250 Participants
are divided into 5 treatment groups