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

Last updated: March 17, 2025
Sponsor: University of Erlangen-Nürnberg Medical School
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

High Cholesterol (Hyperlipidemia)

Treatment

High-intensity interval training

Alternate day fasting

Time restricted eating

Clinical Study ID

NCT06885255
22-60_2-B
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written consent to participate in the study.

  • Persons aged 18 years and older.

  • Diagnosis of Metabolic Syndrome (MetS) with elevated hsCRP.

Exclusion

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 orparticipate in the study.

Study Design

Total Participants: 250
Treatment Group(s): 3
Primary Treatment: High-intensity interval training
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
March 31, 2026

Connect with a study center

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

    Erlangen, Bavaria 91054
    Germany

    Active - Recruiting

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