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Energy Expenditure and Quality of Life in Epilepsy

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ClinicalTrials.gov Identifier: NCT04546711
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : January 19, 2022
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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.

Condition or disease Intervention/treatment
Epilepsy Other: Ketogenic Diet

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.

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Ketogenic Diet on Epilepsy: Metabolism and Quality of Life
Estimated Study Start Date : February 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Group/Cohort Intervention/treatment
Ketogenic Diet
  • Baseline Assessments
  • Ketogenic diet intervention
  • 3 and 6 month Assessments
Other: Ketogenic Diet
The ketogenic diet (KD) is a high fat, very low carbohydrate diet




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Enhanced Metabolic Control of Epilepsy Assessed by Indirect Calorimetry [ Time Frame: baseline, 3 months, 6 months ]
    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.

  2. Change in Physical Activity Level (PAL) as Recorded by Actigraph Measurement [ Time Frame: baseline, 3 months, 6 months ]
    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).

  3. Change in Body Fat Mass [ Time Frame: baseline, 3 months, 6 months ]
    The hypothesis is that KD therapy will contribute to a decrease in fat mass, a maintenance of fat-free mass.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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 carboxylase deficiency
  • Already on ketogenic therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04546711


Contacts
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Contact: Michele Ravelli, MSc, PhD 608-265-6191 ravelli@neurology.wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53705
Contact: Michele Ravelli, MSc, PhD    608-265-6191    ravelli@neurology.wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Elizabeth Felton, MD, PhD University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04546711    
Other Study ID Numbers: 2020-0371
A535100 ( Other Identifier: UW Madison )
SMPH/NEUROLOGY/NEUROLOGY ( Other Identifier: UW Madison )
Protocol Version 4/27/2020 ( Other Identifier: UW Madison )
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: January 19, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
Ketogenic Diet
Quality of Life
Energy Metabolism
Physical Activity
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases