Energy Expenditure and Quality of Life in Epilepsy

NCT04546711 | Withdrawn

• 4 other identifiers: 2020-0371A535100SMPH/NEUROLOGY/NEUROLOGYProtocol Version 4/27/2020
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

Ketogenic Diet; Quality of Life; Energy Metabolism; Physical Activity

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  baseline, 3 months, 6 months

Secondary Outcomes (3)

• Enhanced Metabolic Control of Epilepsy Assessed by Indirect Calorimetry

  baseline, 3 months, 6 months

• Change in Physical Activity Level (PAL) as Recorded by Actigraph Measurement

  baseline, 3 months, 6 months

• Change in Body Fat Mass

  baseline, 3 months, 6 months

Study Arms (1)

Ketogenic Diet

* Baseline Assessments * Ketogenic diet intervention * 3 and 6 month Assessments

Other: Ketogenic Diet

Interventions

Ketogenic Diet OTHER

The ketogenic diet (KD) is a high fat, very low carbohydrate diet

Ketogenic Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Epilepsy; Motor Activity

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Elizabeth Felton, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 14, 2020
• Study Start: June 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)