Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06013761
Status:
RECRUITING
Last Update Posted:
2023-08-28
First Post:
2023-08-08
Brief Title:
IF-MCT 168 Investigating the Influence of Intermittent Fasting With and Without MCTs in Patients With Drug-resistant Epilepsy
Sponsor:
University Hospital Marburg
Organization:
University Hospital Marburg
Study Overview
Official Title:
Monocentric Randomized Experimental Pilot Trial Investigating the Influence of Intermittent Fasting According to the 168 Method With and Without Medium-chain Triglycerides MCTs on Seizure Frequency Biomarkers and Neural Networks in Patients With Drug-resistant Epilepsy
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IF-MCT168
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 168 method IF 168 are compared to 12 weeks intermittent fasting with additional intake of exogenous MCTs IF MCT 168 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 bodys 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 eg 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 168 method IF 168 are compared to 12 weeks intermittent fasting with additional intake of exogenous medium chain triglycerides IF MCT 168 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
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 168 method IF 168 are compared to 12 weeks intermittent fasting with additional intake of exogenous medium chain triglycerides IF MCT 168 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None