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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metabolic syndrome - alternate day fasting | Experimental | Patients with metabolic syndrome who undergo alternate-day fasting in addition to regular advice on the mediterranean diet |
|
| Metabolic syndrome - time restricted eating | Experimental | Patients with metabolic syndrome who undergo time restricted eating in addition to regular advice on the mediterranean diet |
|
| Metabolic syndrome - time restricted eating plus high-intensity interval training | Experimental | Patients with metabolic syndrome who undergo time restricted eating plus high-intensity interval training in addition to regular advice on the mediterranean diet |
|
| Metabolic syndrome - controls | No Intervention | Patients with metabolic syndrome exclusively receiving regular advice on the mediterranean diet | |
| Healthy - controls | No Intervention | Healthy controls exclusively receiving regular advice on the mediterranean diet |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alternate day fasting | Other | Participants are instructed to alternate between consuming 100% of their usual energy intake on one day and only 25% on the following day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| hsCRP | High sensitivity C-reactive protein in mg/l. | From enrollment to the end of intervention at 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| inflammatory markers and metabolic markers | Determination of inflammatory markers and metabolic markers in blood (e.g., sICAM-1, IGF-1, β-hydroxybutyrate, estrogens, androgens). | From enrollment to the end of intervention at 3 months. |
| waist circumference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. med. Yurdagül Zopf | Contact | 0049091318545220 | yurdaguel.zopf@uk-erlangen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hector-Center for Nutrition, Exercise and Sports, University Hospital Erlangen | Recruiting | Erlangen | Bavaria | 91054 | Germany |
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| Time restricted eating | Other | 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 | Other | Patients participate in high-intensity interval training. |
|
Measurement of waist circumference in centimeters (cm). |
| From enrollment to the end of intervention at 3 months. |
| fasting blood glucose | Measurement of fasting blood glucose in milligrams per deciliter (mg/dL). | From enrollment to the end of intervention at 3 months. |
| triglycerides | Measurement of triglycerides in milligrams per deciliter (mg/dL). | From enrollment to the end of intervention at 3 months. |
| cholesterol | Measurement of cholesterol (total, LDL, HDL) in milligrams per deciliter (mg/dL). | From enrollment to the end of intervention at 3 months. |
| blood pressure | Measurement of systolic and diastolic blood pressure in millimeters of mercury (mmHg). | 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. | From enrollment to the end of intervention at 3 months. |
| maximal oxygen uptake | Measurement of maximal oxygen uptake (VO2max) via spiroergometry. | From enrollment to the end of intervention at 3 months. |
| liver fat status | Measurement of liver fat status via ultrasound examination. | 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. | From enrollment to the end of intervention at 3 months. |
| skin microbiome | Determination of the composition of the skin microbiome. | From enrollment to the end of intervention at 3 months. |
| cortisol | Detection of cortisol from 24-hour urine collection. | From enrollment to the end of intervention at 3 months. |
| body weight | Measurement of body weight in kilograms (kg) using bioimpedance analysis. | From enrollment to the end of intervention at 3 months. |
| body fat percentage | Measurement of body fat percentage (%) using bioimpedance analysis. | From enrollment to the end of intervention at 3 months. |
| fat-free mass | Measurement of fat-free mass (in kilograms) using bioimpedance analysis. | From enrollment to the end of intervention at 3 months. |
| muscle mass | Measurement of muscle mass (in kilograms) using bioimpedance analysis. | From enrollment to the end of intervention at 3 months. |
| phase angle | Measurement of phase angle (in degrees) using bioimpedance analysis. | From enrollment to the end of intervention at 3 months. |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| D007249 | Inflammation |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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