Effects of Intermittent Fasting and Exercise on Inflammation, Metabolism, and the Microbiome in Metabolic Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Alternate day fasting, Time restricted eating, High-intensity interval training.
- Who it may be relevant to
- Registry conditions: Metabolic Syndrome, Obesity and Obesity-related Medical Conditions. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Other 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. - Other Time restricted eating
Subjects are instructed to limit their energy intake to 8 hours a day and to fast for the remaining 16 hours. - Other High-intensity interval training
Patients participate in high-intensity interval training.
Primary outcome measures
- hsCRP [Time frame: From enrollment to the end of intervention at 3 months.]
Secondary outcome measures (12)
- inflammatory markers and metabolic markers [Time frame: From enrollment to the end of intervention at 3 months.]
- waist circumference [Time frame: From enrollment to the end of intervention at 3 months.]
- fasting blood glucose [Time frame: From enrollment to the end of intervention at 3 months.]
- triglycerides [Time frame: From enrollment to the end of intervention at 3 months.]
- cholesterol [Time frame: From enrollment to the end of intervention at 3 months.]
- blood pressure [Time frame: From enrollment to the end of intervention at 3 months.]
- cardiometabolic risk profile [Time frame: From enrollment to the end of intervention at 3 months.]
- maximal oxygen uptake [Time frame: From enrollment to the end of intervention at 3 months.]
- liver fat status [Time frame: From enrollment to the end of intervention at 3 months.]
- composition of the intestinal and oral microbiome [Time frame: From enrollment to the end of intervention at 3 months.]
- skin microbiome [Time frame: From enrollment to the end of intervention at 3 months.]
- cortisol [Time frame: From enrollment to the end of intervention at 3 months.]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Hector-Center for Nutrition, Exercise and Sports, University Hospital Erlangen — Erlangen
Identifiers
NCT: NCT06885255 · 22-60_2-B