Effects of Intermittent Fasting and Exercise on Inflammation, Metabolism, and the Microbiome in Metabolic Syndrome
NCT ID: NCT06885255
Last Updated: 2025-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2023-06-01
2026-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Metabolic syndrome - alternate day fasting
Patients with metabolic syndrome who undergo alternate-day fasting in addition to regular advice on the mediterranean diet
Alternate 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.
Metabolic syndrome - time restricted eating
Patients with metabolic syndrome who undergo time restricted eating in addition to regular advice on the mediterranean diet
Time restricted eating
Subjects are instructed to limit their energy intake to 8 hours a day and to fast for the remaining 16 hours.
Metabolic syndrome - time restricted eating plus high-intensity interval training
Patients with metabolic syndrome who undergo time restricted eating plus high-intensity interval training in addition to regular advice on the mediterranean diet
Time restricted eating
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
Patients participate in high-intensity interval training.
Metabolic syndrome - controls
Patients with metabolic syndrome exclusively receiving regular advice on the mediterranean diet
No interventions assigned to this group
Healthy - controls
Healthy controls exclusively receiving regular advice on the mediterranean diet
No interventions assigned to this group
Interventions
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Alternate 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.
Time restricted eating
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
Patients participate in high-intensity interval training.
Eligibility Criteria
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Inclusion Criteria
* Persons aged 18 years and older.
* Diagnosis of Metabolic Syndrome (MetS) with elevated hsCRP.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
Yes
Sponsors
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University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
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yurdagül zopf
Professor of Integrative Medicine with a Focus on Nutritional Medicine (W3), Director of the Hector Center for Nutrition, Exercise, and Sports
Locations
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Hector-Center for Nutrition, Exercise and Sports, University Hospital Erlangen
Erlangen, Bavaria, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22-60_2-B
Identifier Type: -
Identifier Source: org_study_id
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