Metabolic Syndrome, Obesity and Obesity-related Medical Conditions
Conditions
Keywords
obesity, metabolic syndrome, high-intensity interval training, inflammation, intermittent fasting
Brief summary
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
Participants are instructed to alternate between consuming 100% of their usual energy intake on one day and only 25% on the following day.
OTHERTime restricted eating
Subjects are instructed to limit their energy intake to 8 hours a day and to fast for the remaining 16 hours.
OTHERHigh-intensity interval training
Patients participate in high-intensity interval training.
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hsCRP | From enrollment to the end of intervention at 3 months. | High sensitivity C-reactive protein in mg/l. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| waist circumference | From enrollment to the end of intervention at 3 months. | Measurement of waist circumference in centimeters (cm). |
| fasting blood glucose | From enrollment to the end of intervention at 3 months. | Measurement of fasting blood glucose in milligrams per deciliter (mg/dL). |
| triglycerides | From enrollment to the end of intervention at 3 months. | Measurement of triglycerides in milligrams per deciliter (mg/dL). |
| cholesterol | From enrollment to the end of intervention at 3 months. | Measurement of cholesterol (total, LDL, HDL) in milligrams per deciliter (mg/dL). |
| blood pressure | From enrollment to the end of intervention at 3 months. | Measurement of systolic and diastolic blood pressure in millimeters of mercury (mmHg). |
| cardiometabolic risk profile | From enrollment to the end of intervention at 3 months. | 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. |
| maximal oxygen uptake | From enrollment to the end of intervention at 3 months. | Measurement of maximal oxygen uptake (VO2max) via spiroergometry. |
| liver fat status | From enrollment to the end of intervention at 3 months. | Measurement of liver fat status via ultrasound examination. |
| inflammatory markers and metabolic markers | From enrollment to the end of intervention at 3 months. | Determination of inflammatory markers and metabolic markers in blood (e.g., sICAM-1, IGF-1, β-hydroxybutyrate, estrogens, androgens). |
| skin microbiome | From enrollment to the end of intervention at 3 months. | Determination of the composition of the skin microbiome. |
| cortisol | From enrollment to the end of intervention at 3 months. | Detection of cortisol from 24-hour urine collection. |
| body weight | From enrollment to the end of intervention at 3 months. | Measurement of body weight in kilograms (kg) using bioimpedance analysis. |
| body fat percentage | From enrollment to the end of intervention at 3 months. | Measurement of body fat percentage (%) using bioimpedance analysis. |
| fat-free mass | From enrollment to the end of intervention at 3 months. | Measurement of fat-free mass (in kilograms) using bioimpedance analysis. |
| muscle mass | From enrollment to the end of intervention at 3 months. | Measurement of muscle mass (in kilograms) using bioimpedance analysis. |
| phase angle | From enrollment to the end of intervention at 3 months. | Measurement of phase angle (in degrees) using bioimpedance analysis. |
| composition of the intestinal and oral microbiome | From enrollment to the end of intervention at 3 months. | 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. |
Countries
Germany
Contacts
Primary ContactProf. Dr. med. Yurdagül Zopf
Outcome results
None listed