EpilepsyNCT04546711
Energy Expenditure and Quality of Life in Epilepsy
An observational study of Epilepsy, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The main objectives of this study are to investigate the influence of the ketogenic diet (KD), standard care for patients assisted in the UW Health Adult Epilepsy Dietary Therapy Clinic, on changes in the frequency and severity of seizures, QoL, energy substrate metabolism, body energy expenditure components, fat mass… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Ketogenic Diet
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2023to Aug 2025
- Phase
- Observational
- 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
Study population: 25 male and female adults between the ages of 18-45 (for in person participation) and over 18 (for remote participation) with epilepsy.
Who may be able to join
- aged 18-45
- Diagnosis of epilepsy
- Experience an average of 2 or more seizures per month during the 3 months prior to study
- Plan to start oral ketogenic diet therapy (e.g. with the modified Atkins diet)
- Have low average or higher cognitive/intellectual function and are able to complete self-report questionnaires
- over 18 years of age (no age limit)
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- Diagnosis of epilepsy
- Experience an average of 2 or more seizures per month during the 3 months prior to study
- Plan to start oral ketogenic diet therapy (e.g. with the modified Atkins diet)
- Have low average or higher cognitive/intellectual function and are able to complete self-report questionnaires
Who cannot join
- Participants who report being claustrophobic
- Presence of edema, conditions or persistent side effects of medication use (e.g. vomiting, diarrhea, excessive sweating, and burns) that could cause alterations in the body hydration and consequently, be a bias in energy metabolism variables
- Currently using medications that may cause metabolic and/or absorptive alterations (e.g. diuretics, amphetamines, lipase inhibitors, corticosteroids, etc.)
- Unstable metabolic condition (e.g. persistent sodium <130 or glucose <50)
- Liver, kidney, or pancreatic disease
- Hypercholesterolemia (cholesterol > 300mg/dL)
Show all 9Show fewer
- Currently pregnant or planning on becoming pregnant
- Fatty acid oxidation disorder or pyruvate carboxylase deficiency
- Already on ketogenic therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Ketogenic Diet on Epilepsy: Metabolism and Quality of Life
The main objectives of this study are to investigate the influence of the ketogenic diet (KD), standard care for patients assisted in the UW Health Adult Epilepsy Dietary Therapy Clinic, on changes in the frequency and severity of seizures, QoL, energy substrate metabolism, body energy expenditure components, fat mass and fat-free mass in adults with epilepsy. To achieve this objective, twenty-five male and female participants between the ages of 18 and 45 years (or over 18 years for remote participation), who accepted to initiate the KD as a standard of care prescribed by their physician, will be recruited according to inclusion/exclusion criteria. Participants will be on study for 6 months.
Read the detailed description
The ketogenic diet (KD) is a high fat, very low carbohydrate diet that promotes a variety of changes in the chemical processes on the body associated with reduced frequency and severity of seizures in patients with epilepsy. The reasons for this improvement are not yet fully understood and the answers can be related to changes in the biochemical process and the use of different substrates as the main source of energy for the body.
The quality of life (QoL) of patients with epilepsy is highly affected by stigmatization, difficulties with employment, and physical limitations. There is some evidence that the KD may have beneficial effects on QoL in patients with epilepsy, which can be investigated by changes in body energy expenditure (e.g. physical activity level). Studies that associate changes in body energy requirements, body composition and biochemical measures with seizures and QoL are currently limited in the scientific literature.
The main objectives of this study are to investigate the influence of the KD on changes in the frequency and severity of seizures, QoL, energy substrate metabolism, body energy expenditure components, fat mass and fat-free mass in adults with epilepsy. To achieve this objective, twenty-five male and female participants between the ages of 18 and 45 years (or over 18 years old for remote participation, no metabolic analysis will be complete on remote participants) will be recruited according to inclusion/exclusion criteria. Data will be collected at baseline (time of enrollment), and again at 3 and 6 months following diet start. Stable isotope compounds (doubly labeled water) will assess total daily energy expenditure (TDEE) and body composition (fat mass; fat-free mass). Indirect calorimetry will assess the resting energy expenditure (REE) and respiratory quotient for energy substrate oxidation. Biochemical blood exams (fasting glucose and insulin, and ketone bodies) and anthropometric data will provide data on the nutritional and metabolic status of the participant. Seizure frequency, severity, and QoL will be evaluated using validated self-report questionnaires. The physical activity level, obtained through the ratio between TDEE and REE and by wearing of a physical activity monitor, will be used as a predictor of QoL.
The hypothesis is that KD therapy promotes differences in energy metabolism and energy substrate oxidation, which will lead to better metabolic control of epilepsy, reduced frequency and severity of seizures, and also an improved patient QoL. This study is expected to help elucidate the metabolic changes associated with reduced seizure frequency and severity, and improvement of QoL in patients with epilepsy.
- Conditions
- Epilepsy
- Being tested
- Ketogenic Diet
- Keywords
- Ketogenic Diet, Quality of Life, Energy Metabolism, Physical Activity
- Medical subject headings
- Epilepsy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic DietOther
The ketogenic diet (KD) is a high fat, very low carbohydrate diet
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic Diet | * Baseline Assessments
* Ketogenic diet intervention
* 3 and 6 month Assessments Receives: Other: Ketogenic Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Frequency of Seizures Assessed with Participant Seizure Frequency Report
The hypothesis is that participants will have a significant reduction in seizures (>50%) at 3 and 6 months following the start of KD therapy.
Measured: baseline, 3 months, 6 months
Change in Severity of Seizures Assessed by Seizure Severity Questionnaire (SSQ)
The SSQ scores range from 1-7 with lower scores indicating improved status. The hypothesize is that participants will have a significant reduction in seizures (>50%) at 3 and 6 months following the start of KD therapy, which will also lead a significant reduction (p<0.05) of SSQ overall score.
Measured: baseline, 3 months, 6 months
Change in the Quality of Life in Epilepsy (QOLIE-31-P) Score
The QOLIE-31-P instruments include seven multi-item scales that tap the following health concepts: emotional well-being, social functioning, energy/fatigue, cognitive functioning, seizure worry, medication effects, and overall quality of life. The total range of possible scores is 0-100, higher scores indicate better well being. The hypothesis is that participants will have a significant reduction in seizures (>50%) at 3 and 6 months following the start of KD therapy, which will also lead to significant improvement (p<0.05) in the QoL overall score.
Measured: baseline, 3 months, 6 months
Secondary outcomes (3)
Enhanced Metabolic Control of Epilepsy Assessed by Indirect Calorimetry
The hypothesis is that KD therapy will promote significant differences (compared to pre-diet baseline) in substrate oxidation (an increase in fat oxidation and a decrease in carbohydrate oxidation) which will correlate with seizure reduction.
Measured: baseline, 3 months, 6 months
Change in Physical Activity Level (PAL) as Recorded by Actigraph Measurement
The hypothesis is that KD therapy will contribute to an increase of PAL (direct contribution of KD), leading to an increase of total daily energy expenditure (TDEE) (indirect contribution of KD).
Measured: baseline, 3 months, 6 months
Change in Body Fat Mass
The hypothesis is that KD therapy will contribute to a decrease in fat mass, a maintenance of fat-free mass.
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study startJun 2023 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Why it stopped: decided not to process with study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Felton, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546711
- Sponsor's protocol ID
- 2020-0371
- Other IDs
- A535100, SMPH/NEUROLOGY/NEUROLOGY, Protocol Version 4/27/2020
- Status last verified
- Jun 2023
- First submitted
- 4 Sep 2020
- Last updated
- 29 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ketogenic Diet on Epilepsy: Metabolism and Quality of Life
- ClinicalTrials.gov ID
- NCT04546711
- Acronym / sponsor ID
- 2020-0371
- Conditions
- Epilepsy
- Keywords
- Ketogenic Diet, Quality of Life, Energy Metabolism, Physical Activity
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: decided not to process with study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 14 Sep 2020 (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 main objectives of this study are to investigate the influence of the ketogenic diet (KD), standard care for patients assisted in the UW Health Adult Epilepsy Dietary Therapy Clinic, on changes in the frequency and severity of seizures, QoL, energy substrate metabolism, body energy expenditure components, fat mass and fat-free mass in adults with epilepsy. To achieve this objective, twenty-five male and female participants between the ages of 18 and 45 years (or over 18 years for remote participation), who accepted to initiate the KD as a standard of care prescribed by their physician, will be recruited according to inclusion/exclusion criteria. Participants will be on study for 6 months.
Detailed description
The ketogenic diet (KD) is a high fat, very low carbohydrate diet that promotes a variety of changes in the chemical processes on the body associated with reduced frequency and severity of seizures in patients with epilepsy. The reasons for this improvement are not yet fully understood and the answers can be related to changes in the biochemical process and the use of different substrates as the main source of energy for the body.
The quality of life (QoL) of patients with epilepsy is highly affected by stigmatization, difficulties with employment, and physical limitations. There is some evidence that the KD may have beneficial effects on QoL in patients with epilepsy, which can be investigated by changes in body energy expenditure (e.g. physical activity level). Studies that associate changes in body energy requirements, body composition and biochemical measures with seizures and QoL are currently limited in the scientific literature.
The main objectives of this study are to investigate the influence of the KD on changes in the frequency and severity of seizures, QoL, energy substrate metabolism, body energy expenditure components, fat mass and fat-free mass in adults with epilepsy. To achieve this objective, twenty-five male and female participants between the ages of 18 and 45 years (or over 18 years old for remote participation, no metabolic analysis will be complete on remote participants) will be recruited according to inclusion/exclusion criteria. Data will be collected at baseline (time of enrollment), and again at 3 and 6 months following diet start. Stable isotope compounds (doubly labeled water) will assess total daily energy expenditure (TDEE) and body composition (fat mass; fat-free mass). Indirect calorimetry will assess the resting energy expenditure (REE) and respiratory quotient for energy substrate oxidation. Biochemical blood exams (fasting glucose and insulin, and ketone bodies) and anthropometric data will provide data on the nutritional and metabolic status of the participant. Seizure frequency, severity, and QoL will be evaluated using validated self-report questionnaires. The physical activity level, obtained through the ratio between TDEE and REE and by wearing of a physical activity monitor, will be used as a predictor of QoL.
The hypothesis is that KD therapy promotes differences in energy metabolism and energy substrate oxidation, which will lead to better metabolic control of epilepsy, reduced frequency and severity of seizures, and also an improved patient QoL. This study is expected to help elucidate the metabolic changes associated with reduced seizure frequency and severity, and improvement of QoL in patients with epilepsy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketogenic Diet | – | Other: Ketogenic Diet* Baseline Assessments * Ketogenic diet intervention * 3 and 6 month Assessments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 25 male and female adults between the ages of 18-45 (for in person participation) and over 18 (for remote participation) with epilepsy.
Key inclusion criteria (10 listed)
- aged 18-45
- Diagnosis of epilepsy
- Experience an average of 2 or more seizures per month during the 3 months prior to study
- Plan to start oral ketogenic diet therapy (e.g. with the modified Atkins diet)
- Have low average or higher cognitive/intellectual function and are able to complete self-report questionnaires
Key exclusion criteria (9 listed)
- Participants who report being claustrophobic
- Presence of edema, conditions or persistent side effects of medication use (e.g. vomiting, diarrhea, excessive sweating, and burns) that could cause alterations in the body hydration and consequently, be a bias in energy metabolism variables
- Currently using medications that may cause metabolic and/or absorptive alterations (e.g. diuretics, amphetamines, lipase inhibitors, corticosteroids, etc.)
- Unstable metabolic condition (e.g. persistent sodium <130 or glucose <50)
- Liver, kidney, or pancreatic 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 |
|---|---|---|
| Ketogenic DietThe ketogenic diet (KD) is a high fat, very low carbohydrate diet | Other | Ketogenic Diet |
Primary outcome
Change in the Frequency of Seizures Assessed with Participant Seizure Frequency Report
Time frame: baseline, 3 months, 6 months
The hypothesis is that participants will have a significant reduction in seizures (>50%) at 3 and 6 months following the start of KD therapy.
Change in Severity of Seizures Assessed by Seizure Severity Questionnaire (SSQ)
Time frame: baseline, 3 months, 6 months
The SSQ scores range from 1-7 with lower scores indicating improved status. The hypothesize is that participants will have a significant reduction in seizures (>50%) at 3 and 6 months following the start of KD therapy, which will also lead a significant reduction (p<0.05) of SSQ overall score.
Change in the Quality of Life in Epilepsy (QOLIE-31-P) Score
Time frame: baseline, 3 months, 6 months
The QOLIE-31-P instruments include seven multi-item scales that tap the following health concepts: emotional well-being, social functioning, energy/fatigue, cognitive functioning, seizure worry, medication effects, and overall quality of life. The total range of possible scores is 0-100, higher scores indicate better well being. The hypothesis is that participants will have a significant reduction in seizures (>50%) at 3 and 6 months following the start of KD therapy, which will also lead to significant improvement (p<0.05) in the QoL overall score.
3 secondary outcomes
Enhanced Metabolic Control of Epilepsy Assessed by Indirect Calorimetry
Time frame: baseline, 3 months, 6 months
Change in Physical Activity Level (PAL) as Recorded by Actigraph Measurement
Time frame: baseline, 3 months, 6 months
Change in Body Fat Mass
Time frame: baseline, 3 months, 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- 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.
Elizabeth Felton, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by University of Wisconsin, Madison at 1 site in United States.
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 10 inclusion and 9 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: withdrawn, as of the sponsor's last update on 29 Jun 2023. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in the Frequency of Seizures Assessed with Participant Seizure Frequency Report (time frame: baseline, 3 months, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2023.