Epilepsy Clinical Trial
— IF-MCT16:8Official title:
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
The objective of the prospective monocentric pilot trial is to investigate the influence of intermittent fasting with or without a once-daily intake with medium chain triglycerides (MCTs) on the frequency of seizures in patients with therapy-refractory epilepsy. The effects of 12 weeks intermittent fasting according to the 16:8 method (IF 16:8) are compared to 12 weeks intermittent fasting with additional intake of exogenous MCTs (IF MCT 16:8) in a within-subject-crossover-design in 28 patients with drug-resistant epilepsy.
Status | Recruiting |
Enrollment | 28 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Philipps University Marburg, Faculty of Medicine, Department of Neurology, Epilepsy Center | Marburg | Hessen |
Lead Sponsor | Collaborator |
---|---|
University Hospital Marburg |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of intermittent fasting according to the 16:8 method with and without exogenous MCTs on seizure frequency in drug-resistant epilepsy | Monthly seizure frequency is recorded using standardized seizure diaries. | 3 months | |
Secondary | Effect of intermittent fasting according to the 16:8 method on therapy adherence in patients with drug-resistant epilepsy | The nutritional behavior during the studio is recorded using a standardized daily nutrition diary. | 3 months | |
Secondary | Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on ketosis in patients with drug-resistant epilepsy | All participants measure their ketosis weekly with a standardized ketosis device during the fasting episode and document this in a ketosis table provided. | 3 months | |
Secondary | Effect of intermittent fasting according to the 16:8 method on self-efficacy in patients with drug-resistant epilepsy | Self-efficacy is determined using the scale of general self-efficacy expectation (Jerusalem & Schwarzer). This includes 10 items with 4 degrees. High scores mean a high level of general self-efficacy expectation. | 3 months | |
Secondary | Effect of intermittent fasting according to the 16:8 method on life-quality in patients with drug-resistant epilepsy | Life-quality is measured using the standardized questionnaire on life quality. | 3 months | |
Secondary | Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on biomarkers in patients with drug-resistant epilepsy | The metabolome is examined using a mass spectroscopic blood sample. The microbiome is examined using a standardized stool sample using next-generation sequencing. | 3 months | |
Secondary | Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on neural networks in patients with drug-resistant epilepsy | Neural networks are measured using magnetic resonance imaging (diffusion tensor imaging and resting state MRI). | 3 months | |
Secondary | Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on immune status in patients with drug-resistant epilepsy | The immune status and in particular the T-cell mediated innate immune response is determined serologically. | 3 months | |
Secondary | Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on fatigue in patients with drug-resistant epilepsy | Fatigue is measured using the standardized Fatigue-Impact-Scale (FIS)-Test. | 3 months | |
Secondary | Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on attention in patients with drug-resistant epilepsy | Attention is measured using the standardized test battery for attention testing (TAP-Test). | 3 months | |
Secondary | Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on neurotransmitter gamma-aminobutyric acid (GABA)in patients with drug-resistant epilepsy | The change in the neurotransmitter GABA is examined serologically over the period of the study phase. | 3 months | |
Secondary | Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on stress response in patients with drug-resistant epilepsy | Stress response in hair cortisol of all participants is recorded using several hair samples. | 3 months | |
Secondary | Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on intima media thickness in patients with drug-resistant epilepsy | Intima media thickness of all participants will be recorded with a duplex sonographic examination of the arteries supplying the brain. | 3 months |
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