Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06885255

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 80 Years
SexAll
Healthy volunteersAccepted
ConditionMetabolic Syndrome, Obesity and Obesity-related Medical Conditions

Full registry criteria

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.

Treatments and study arms

Alternate day fasting

Other

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 eating

Other

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

High-intensity interval training

Other

Patients participate in high-intensity interval training.

Primary outcomes

hsCRPFrom enrollment to the end of intervention at 3 months.

High sensitivity C-reactive protein in mg/l.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Hector-Center for Nutrition, Exercise and Sports, University Hospital Erlangen🇩🇪 Erlangen, Bavaria, Germany
Prof. Dr. med. Yurdagül ZopfContact