EpilepsyIF-MCT16:8NCT06013761
IF-MCT 16:8: Investigating the Influence of Intermittent Fasting With and Without MCTs in Patients With Drug-resistant Epilepsy
A study testing IF 16:8 as active comparator vs. IF MCT 16:8 as experimental arm in people with Epilepsy and Intermittent Fasting, run by University Hospital Marburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Intermittent Fasting
- What is being tested?
- IF 16:8 as active comparator vs. IF MCT 16:8 as experimental arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jul 2023to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects able to provide informed consent
- Drug-resistant epilepsy
- At least 3 seizures per month
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Philipps University Marburg, Faculty of Medicine, Department of Neurology, Epilepsy Center
Marburg, Hesse, Baldingerstr., 35043
About this study
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
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.
Read the 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
- Being tested
- IF 16:8 as active comparator vs. IF MCT 16:8 as experimental arm
- Keywords
- Drug-resistant epilepsy, Intermittent fasting, Seizure frequency, Biomarkers, Neural networks, Microbiome
- Medical subject headings
- Epilepsy, Intermittent Fasting, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| IF 16:8 | Active comparator | 12 weeks intermittent fasting according to the 16:8 method (IF 16:8) Receives: 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) Receives: Other: IF 16:8 as active comparator vs. IF MCT 16:8 as experimental arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (12)
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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).
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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).
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start25 Jul 2023
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanne Knake, Philipps University Marburg
- Investigators
- Wiebke Hahn, MD, Principal investigator, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013761
- Sponsor's protocol ID
- 23-92 BO
- Acronym
- IF-MCT16:8
- Status last verified
- Nov 2025
- First submitted
- 8 Aug 2023
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hahn W, Falk E, Balzter A, Foer T, Maierhofer S, Jaumann S, Strehlau S, Moller L, Tsalouchidou PE, Menzler K, Timmermann L, Knake S. Intermittent fasting with medium-chain triglycerides in drug-resistant epilepsy: A pilot crossover trial. Epilepsia. 2026 Jun 26. doi: 10.1002/epi.70343. Online ahead of print.
PubMed 42360174
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06013761
- Acronym / sponsor ID
- IF-MCT16:8 / 23-92 BO
- Conditions
- Epilepsy, Intermittent Fasting
- Keywords
- Drug-resistant epilepsy, Intermittent fasting, Seizure frequency, Biomarkers, Neural networks, Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital MarburgUniversity, hospital or other
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IF 16:8 | Active comparator | Other: IF 16:8 as active comparator vs. IF MCT 16:8 as experimental arm12 weeks intermittent fasting according to the 16:8 method (IF 16:8) |
| IF MCT 16:8 | Experimental | Other: IF 16:8 as active comparator vs. IF MCT 16:8 as experimental arm12 weeks intermittent fasting with additional intake of exogenous MCTs (IF MCT 16:8) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects able to provide informed consent
- Drug-resistant epilepsy
- At least 3 seizures per month
Key exclusion criteria (7 listed)
- Pregnancy
- Breast feeding period
- Metabolic disorder (e.g. diabetes, liver cirrhosis, kidney disease)
- Eating Disorder (e.g. anorexia, bulimia)
- Chronic inflammatory gut disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IF 16:8 as active comparator vs. IF MCT 16:8 as experimental arm12 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. | Other | IF 16:8, IF MCT 16:8 |
Primary outcome
Effect of intermittent fasting according to the 16:8 method with and without exogenous MCTs on seizure frequency in drug-resistant epilepsy
Time frame: 3 months
Monthly seizure frequency is recorded using standardized seizure diaries.
12 secondary outcomes
Effect of intermittent fasting according to the 16:8 method on therapy adherence in patients with drug-resistant epilepsy
Time frame: 3 months
Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on ketosis in patients with drug-resistant epilepsy
Time frame: 3 months
Effect of intermittent fasting according to the 16:8 method on self-efficacy in patients with drug-resistant epilepsy
Time frame: 3 months
Effect of intermittent fasting according to the 16:8 method on life-quality in patients with drug-resistant epilepsy
Time frame: 3 months
Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on biomarkers in patients with drug-resistant epilepsy
Time frame: 3 months
Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on neural networks in patients with drug-resistant epilepsy
Time frame: 3 months
Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on immune status in patients with drug-resistant epilepsy
Time frame: 3 months
Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on fatigue in patients with drug-resistant epilepsy
Time frame: 3 months
Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on attention in patients with drug-resistant epilepsy
Time frame: 3 months
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
Time frame: 3 months
Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on stress response in patients with drug-resistant epilepsy
Time frame: 3 months
Effect of intermittent fasting according to the 16:8 method with exogenous MCTs on intima media thickness in patients with drug-resistant epilepsy
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Derived from this study: PubMed 42360174Hahn W, Falk E, Balzter A, Foer T, Maierhofer S, Jaumann S, Strehlau S, Moller L, Tsalouchidou PE, Menzler K, Timmermann L, Knake S. Intermittent fasting with medium-chain triglycerides in drug-resistant epilepsy: A pilot crossover trial. Epilepsia. 2026 Jun 26. doi: 10.1002/epi.70343. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wiebke Hahn, MD principal investigator
Philipps University Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IF 16:8 as active comparator vs. IF MCT 16:8 as experimental arm in people with Epilepsy and Intermittent Fasting, run by University Hospital Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of intermittent fasting according to the 16:8 method with and without exogenous MCTs on seizure frequency in drug-resistant epilepsy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06013761, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.