Clinical trial NCT06013761: IF-MCT 16:8: Investigating the Influence of Intermittent Fasting With and Without MCTs in Patients With Drug-resistant Epilepsy
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Intermittent Fasting
Keywords: Drug-resistant epilepsy
Intermittent fasting
Seizure frequency
Biomarkers
Neural networks
Microbiome
Lead sponsor: University Hospital Marburg
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: One in three patients suffering epilepsy does not become seizure-free with conventional pharmacotherapy. The chance of seizure freedom with each additional medication is only in the single-digit percentage range. For this reason, additive therapies such as the ketogenic diet play an important role. By means of a ketogenic diet, a significant reduction in the frequency of seizures has been shown in various studies for children. The main goal is the body's own production of ketone bodies in the liver, which are used instead of glucose to produce the energy carrier ATP. This metabolic change results in biochemical, metabolic and hormonal changes that may reduce the severity and frequency of epileptic seizures, although the exact mechanisms are not yet understood. Common to all forms of ketogenic diets (e.g. classic kKD, modified Atkins diet, low glycemic index diet) is a specific preparation of each meal with plans for meals and often an initiation of additive therapy in the inpatient setting or by trained staff. Especially in adulthood, the lack of treatment adherence seems to play an important role in the effectiveness of the ketogenic diet. A form of ketogenic diet which might be more suitable for everyday use is intermittent fasting.

The primary aim of the prospective monocentric pilot trial is to investigate the effect of intermittent fasting with and without a once-daily intake of 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 medium chain triglycerides (IF MCT 16:8) in a within-subject-crossover design in 28 patients with drug-resistant epilepsy. Secondarily, the influence of this diet on the composition of the gut microbiome, the T-cell mediated innate immune system and neuronal signalling pathways and networks will be investigated.

Eligibility 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

Primary outcomes:
measure: Effect of intermittent fasting according to the 16:8 method with and without exogenous MCTs on seizure frequency in drug-resistant epilepsy
timeFrame: 3 months
Secondary outcomes:
measure: Effect of intermittent fasting according to the 16:8 method on therapy adherence in patients with drug-resistant epilepsy
timeFrame: 3 months
measure: Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on ketosis in patients with drug-resistant epilepsy
timeFrame: 3 months
measure: Effect of intermittent fasting according to the 16:8 method on self-efficacy in patients with drug-resistant epilepsy
timeFrame: 3 months
measure: Effect of intermittent fasting according to the 16:8 method on life-quality in patients with drug-resistant epilepsy
timeFrame: 3 months
measure: Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on biomarkers in patients with drug-resistant epilepsy
timeFrame: 3 months
measure: Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on neural networks in patients with drug-resistant epilepsy
timeFrame: 3 months
measure: Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on immune status in patients with drug-resistant epilepsy
timeFrame: 3 months
measure: Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on fatigue in patients with drug-resistant epilepsy
timeFrame: 3 months
measure: Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on attention in patients with drug-resistant epilepsy
timeFrame: 3 months
measure: 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
timeFrame: 3 months
measure: Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on stress response in patients with drug-resistant epilepsy
timeFrame: 3 months
measure: Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on intima media thickness in patients with drug-resistant epilepsy
timeFrame: 3 months
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Philipps University Marburg, Faculty of Medicine, Department of Neurology, Epilepsy Center
state: Hessen
Study officials:
affiliation: Philipps University Marburg
name: Wiebke Hahn, MD
role: PRINCIPAL_INVESTIGATOR
References: