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

University of Erlangen-Nürnberg Medical School

Status: Enrolling

Conditions: Obesity and Obesity-related Medical Conditions; Metabolic Syndrome

Treatments: Other: Time restricted eating; Other: Alternate day fasting; Other: High-intensity interval training

Study type: Interventional

Funder types: Other

Identifiers

NCT06885255

22-60_2-B

Details and patient eligibility

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 5 patient groups

Metabolic syndrome - alternate day fasting

Experimental group

Description:

Patients with metabolic syndrome who undergo alternate-day fasting in addition to regular advice on the mediterranean diet

Treatment:

Other: Alternate day fasting

Metabolic syndrome - time restricted eating

Experimental group

Description:

Patients with metabolic syndrome who undergo time restricted eating in addition to regular advice on the mediterranean diet

Treatment:

Other: Time restricted eating

Metabolic syndrome - time restricted eating plus high-intensity interval training

Experimental group

Description:

Patients with metabolic syndrome who undergo time restricted eating plus high-intensity interval training in addition to regular advice on the mediterranean diet

Treatment:

Other: High-intensity interval training

Other: Time restricted eating

Metabolic syndrome - controls

No Intervention group

Description:

Patients with metabolic syndrome exclusively receiving regular advice on the mediterranean diet

Healthy - controls

No Intervention group

Description:

Healthy controls exclusively receiving regular advice on the mediterranean diet