Investigating intermittent fasting with and without MCTs for drug-resistant epilepsy
Monocentric Randomized Experimental Pilot Trial Investigating the Influence of Intermittent Fasting According to the 16:8 Method With and Without Medium-chain Triglycerides (MCTs) on Seizure Frequency, Biomarkers and Neural Networks in Patients With Drug-resistant Epilepsy
NA · University Hospital Marburg · NCT06013761
This study is testing if intermittent fasting with or without a special type of fat can help reduce seizures in people with epilepsy that doesn't respond to regular treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Marburg (other) |
| Locations | 1 site (Marburg, Hessen) |
| Trial ID | NCT06013761 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to explore the effects of intermittent fasting using the 16:8 method, both with and without the addition of medium-chain triglycerides (MCTs), on seizure frequency in patients with drug-resistant epilepsy. The study will involve a within-subject crossover design, comparing the two approaches over a 12-week period in 28 participants. The goal is to determine if these dietary interventions can effectively reduce seizure occurrences in individuals who do not respond to conventional treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with drug-resistant epilepsy experiencing at least three seizures per month.
Not a fit: Patients who are pregnant, breastfeeding, or have metabolic disorders or chronic inflammatory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new dietary intervention for patients with drug-resistant epilepsy, potentially reducing seizure frequency and improving quality of life.
How similar studies have performed: While ketogenic diets have shown success in reducing seizures in children, the specific approach of intermittent fasting with MCTs in adults is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects able to provide informed consent * Drug-resistant epilepsy * At least 3 seizures per month Exclusion Criteria: * Pregnancy * Breast feeding period * Metabolic disorder (e.g. diabetes, liver cirrhosis, kidney disease) * Eating Disorder (e.g. anorexia, bulimia) * Chronic inflammatory gut disease * Active cancerous disease * Antibiotics within the last 3 months
Where this trial is running
Marburg, Hessen
- Philipps University Marburg, Faculty of Medicine, Department of Neurology, Epilepsy Center — Marburg, Hessen, Germany (RECRUITING)
Study contacts
- Principal investigator: Wiebke Hahn, MD — Philipps University Marburg
- Study coordinator: Wiebke Hahn, MD
- Email: Hahnwi@staff.uni-marburg.de
- Phone: +49 642158 65348
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.
Conditions: Epilepsy, Intermittent Fasting, Drug-resistant epilepsy, Intermittent fasting, Seizure frequency, Biomarkers, Neural networks, Microbiome