NCT06013761

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

1.9 years

First QC Date

August 8, 2023

Last Update Submit

November 26, 2025

Conditions

EpilepsyIntermittent Fasting

Keywords

Drug-resistant epilepsyIntermittent fastingSeizure frequencyBiomarkersNeural networksMicrobiome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Effect of intermittent fasting according to the 16:8 method on therapy adherence in patients with drug-resistant epilepsy

    3 months

  • Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on ketosis in patients with drug-resistant epilepsy

    3 months

  • Effect of intermittent fasting according to the 16:8 method on self-efficacy in patients with drug-resistant epilepsy

    3 months

  • Effect of intermittent fasting according to the 16:8 method on life-quality in patients with drug-resistant epilepsy

    3 months

  • Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on biomarkers in patients with drug-resistant epilepsy

    3 months

  • +7 more secondary outcomes

Study Arms (2)

IF 16:8

ACTIVE COMPARATOR

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

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

IF MCT 16:8

EXPERIMENTAL

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

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

Interventions

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

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 16:8IF MCT 16:8

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects able to provide informed consent
  • Drug-resistant epilepsy
  • At least 3 seizures per month

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Marburg, Hesse, Baldingerstr., 35043, Germany

Location

MeSH Terms

Conditions

EpilepsyIntermittent FastingDrug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesFastingFeeding BehaviorBehavior

Study Officials

  • Wiebke Hahn, MD

    Philipps University Marburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 28, 2023

Study Start

July 25, 2023

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

December 4, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)