IF-MCT 16:8: Investigating the Influence of Intermittent Fasting With and Without MCTs in Patients With Drug-resistant Epilepsy

NCT ID: NCT06013761

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-25
• Study Completion Date: 2025-05-31

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.

Conditions

Epilepsy; Intermittent Fasting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IF 16:8

12 weeks intermittent fasting according to the 16:8 method (IF 16:8)

Group Type: ACTIVE_COMPARATOR

IF 16:8 as active comparator vs. IF MCT 16:8 as experimental arm

Intervention Type: OTHER

12 weeks intermittent fasting according to the 16:8 method (IF 16:8) are compared with 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. In order to enable the highest possible adherence, there are no restrictions on the composition of the food.

IF MCT 16:8

12 weeks intermittent fasting with additional intake of exogenous MCTs (IF MCT 16:8)

Group Type: EXPERIMENTAL

IF 16:8 as active comparator vs. IF MCT 16:8 as experimental arm

Intervention Type: OTHER

12 weeks intermittent fasting according to the 16:8 method (IF 16:8) are compared with 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. In order to enable the highest possible adherence, there are no restrictions on the composition of the food.

Interventions

IF 16:8 as active comparator vs. IF MCT 16:8 as experimental arm

12 weeks intermittent fasting according to the 16:8 method (IF 16:8) are compared with 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. In order to enable the highest possible adherence, there are no restrictions on the composition of the food.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Marburg

OTHER

Sponsor Role: lead

Responsible Party

Susanne Knake

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wiebke Hahn, MD

Role: PRINCIPAL_INVESTIGATOR

Philipps University Marburg

Locations

Philipps University Marburg, Faculty of Medicine, Department of Neurology, Epilepsy Center

Marburg, Hesse, Germany

Countries

Germany

Other Identifiers

23-92 BO

Identifier Type: -

Identifier Source: org_study_id