Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04546711 |
| Other study ID # |
2020-0371 |
| Secondary ID |
A535100SMPH/NEUR |
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 2023 |
| Est. completion date |
August 2025 |
Study information
| Verified date |
June 2023 |
| Source |
University of Wisconsin, Madison |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
