An interventional study of Alternate day fasting and Time restricted eating in Metabolic Syndrome and Obesity and Obesity-related Medical Conditions, sponsored by University of Erlangen-Nürnberg Medical School. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by University of Erlangen-Nürnberg Medical School · Not applicable, Interventional, and Treatment
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 250 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of Erlangen-Nürnberg Medical School is the lead sponsor of 267 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Patients with metabolic syndrome who undergo alternate-day fasting in addition to regular advice on the mediterranean diet
Other: Alternate day fasting
Patients with metabolic syndrome who undergo time restricted eating in addition to regular advice on the mediterranean diet
Other: Time restricted eating
Patients with metabolic syndrome who undergo time restricted eating plus high-intensity interval training in addition to regular advice on the mediterranean diet
Other: Time restricted eating · Other: High-intensity interval training
Patients with metabolic syndrome exclusively receiving regular advice on the mediterranean diet
Healthy controls exclusively receiving regular advice on the mediterranean diet
Participants are instructed to alternate between consuming 100% of their usual energy intake on one day and only 25% on the following day.
Subjects are instructed to limit their energy intake to 8 hours a day and to fast for the remaining 16 hours.
Patients participate in high-intensity interval training.
hsCRP
High sensitivity C-reactive protein in mg/l.
Time frame: From enrollment to the end of intervention at 3 months.
inflammatory markers and metabolic markers
Determination of inflammatory markers and metabolic markers in blood (e.g., sICAM-1, IGF-1, β-hydroxybutyrate, estrogens, androgens).
Time frame: From enrollment to the end of intervention at 3 months.
waist circumference
Measurement of waist circumference in centimeters (cm).
Time frame: From enrollment to the end of intervention at 3 months.
fasting blood glucose
Measurement of fasting blood glucose in milligrams per deciliter (mg/dL).
Time frame: From enrollment to the end of intervention at 3 months.
triglycerides
Measurement of triglycerides in milligrams per deciliter (mg/dL).
Time frame: From enrollment to the end of intervention at 3 months.
cholesterol
Measurement of cholesterol (total, LDL, HDL) in milligrams per deciliter (mg/dL).
Time frame: From enrollment to the end of intervention at 3 months.
blood pressure
Measurement of systolic and diastolic blood pressure in millimeters of mercury (mmHg).
Time frame: From enrollment to the end of intervention at 3 months.
cardiometabolic risk profile
Calculation of the MetS z-score by combining waist circumference, fasting blood glucose, triglycerides, cholesterol, and blood pressure. The z-score will be reported as a single value based on these separate measures.
Time frame: From enrollment to the end of intervention at 3 months.
maximal oxygen uptake
Measurement of maximal oxygen uptake (VO2max) via spiroergometry.
Time frame: From enrollment to the end of intervention at 3 months.
liver fat status
Measurement of liver fat status via ultrasound examination.
Time frame: From enrollment to the end of intervention at 3 months.
composition of the intestinal and oral microbiome
Determination of the composition of the intestinal and oral microbiome by sequencing bacterial 16sRNA on the MiSeq platform, as well as analysis of the stool metabolome.
Time frame: From enrollment to the end of intervention at 3 months.
skin microbiome
Determination of the composition of the skin microbiome.
Time frame: From enrollment to the end of intervention at 3 months.
cortisol
Detection of cortisol from 24-hour urine collection.
Time frame: From enrollment to the end of intervention at 3 months.
body weight
Measurement of body weight in kilograms (kg) using bioimpedance analysis.
Time frame: From enrollment to the end of intervention at 3 months.
body fat percentage
Measurement of body fat percentage (%) using bioimpedance analysis.
Time frame: From enrollment to the end of intervention at 3 months.
fat-free mass
Measurement of fat-free mass (in kilograms) using bioimpedance analysis.
Time frame: From enrollment to the end of intervention at 3 months.
muscle mass
Measurement of muscle mass (in kilograms) using bioimpedance analysis.
Time frame: From enrollment to the end of intervention at 3 months.
phase angle
Measurement of phase angle (in degrees) using bioimpedance analysis.
Time frame: From enrollment to the end of intervention at 3 months.
Plan to share: No
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University of Erlangen-Nürnberg Medical School