RecruitingNot ApplicableNCT06885255

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


Sponsor

University of Erlangen-Nürnberg Medical School

Enrollment

250 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

  • Written consent to participate in the study.
  • Persons aged 18 years and older.
  • Diagnosis of Metabolic Syndrome (MetS) with elevated hsCRP.

Exclusion Criteria5

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERAlternate 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.

OTHERTime restricted eating

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

OTHERHigh-intensity interval training

Patients participate in high-intensity interval training.


Locations(1)

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

Erlangen, Bavaria, Germany

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06885255


Related Trials