About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Written consent to participate in the study.
Persons aged 18 years and older.
Diagnosis of Metabolic Syndrome (MetS) with elevated hsCRP.
Disqualifiers
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).
Trial design
Parallel
Treatments tested in this trial
Alternate day fasting
Other interventionParticipants 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 interventionSubjects 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 interventionPatients participate in high-intensity interval training.
Treatment groups
Trial outcomes
Primary outcomes
hsCRP
High sensitivity C-reactive protein in mg/l.
Secondary outcomes
inflammatory markers and metabolic markers
Determination of inflammatory markers and metabolic markers in blood (e.g., sICAM-1, IGF-1, β-hydroxybutyrate, estrogens, androgens).
waist circumference
Measurement of waist circumference in centimeters (cm).
fasting blood glucose
Measurement of fasting blood glucose in milligrams per deciliter (mg/dL).
triglycerides
Measurement of triglycerides in milligrams per deciliter (mg/dL).
Sponsors and contacts
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