Energy Expenditure and Quality of Life in Epilepsy (NCT04546711) | Clinical Trial Compass
WithdrawnNot Applicable
Energy Expenditure and Quality of Life in Epilepsy
Stopped: decided not to process with study
United States0Started 2023-06
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria (in person participation):
* 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
Inclusion Criteria for Remote Participation:
* over 18 years of age (no age limit)
* 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
Exclusion Criteria:
* 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)
* Currently pregnant or planning on becoming pregnant
* Fatty acid oxidation disorder or pyruvate ca…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Frequency of Seizures Assessed with Participant Seizure Frequency Report
Timeframe: baseline, 3 months, 6 months
2
Change in Severity of Seizures Assessed by Seizure Severity Questionnaire (SSQ)
Timeframe: baseline, 3 months, 6 months
3
Change in the Quality of Life in Epilepsy (QOLIE-31-P) Score