Effects of intermittent fasting and exercise on inflammation and metabolism in metabolic syndrome
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
This study is testing if intermittent fasting alone or with high-intensity exercise can reduce inflammation and improve metabolism in people with obesity and metabolic syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Locations | 1 site (Erlangen, Bavaria) |
| Trial ID | NCT06885255 on ClinicalTrials.gov |
What this trial studies
This intervention assesses how intermittent fasting, both alone and combined with high-intensity interval training, impacts inflammation and metabolism in individuals with obesity and metabolic syndrome. Participants will engage in a 3-month fasting regimen, with one group also participating in high-intensity interval training twice a week. The study includes control groups of individuals with metabolic syndrome and healthy individuals, and it features multiple in-house visits for assessments and nutritional counseling over a total of 6 months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with metabolic syndrome and elevated hsCRP levels.
Not a fit: Patients with cardiovascular diseases, orthopedic restrictions, or those who are pregnant or nursing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new strategies for managing obesity and metabolic syndrome through lifestyle interventions.
How similar studies have performed: Other studies have shown promising results with intermittent fasting and exercise in similar populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Erlangen, Bavaria
- Hector-Center for Nutrition, Exercise and Sports, University Hospital Erlangen — Erlangen, Bavaria, Germany (Recruiting)
Study contacts
- Study coordinator: Prof. Dr. med. Yurdagül Zopf
- Email: yurdaguel.zopf@uk-erlangen.de
- Phone: 0049091318545220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.