Evaluation of Keyo in Children With Epilepsy

Not Applicable

Completed

• Conditions: Intractable Epilepsy; Glucose Transporter Type 1 Deficiency Syndrome; Ketogenic Dieting
• Interventions: Dietary Supplement: Keyo

• Registration Number: NCT02915211
• Lead Sponsor: Vitaflo International, Ltd

Brief Summary

To evaluate the tolerance, acceptability and compliance of Keyo in 20 subjects aged 3 years and over, with intractable epilepsy or Glut-1 DS on a KD.

Detailed Description

Qualitative assessments from subject questionnaires that allow evaluation of the acceptability and ease of use of the study product.

Collection of daily data about the gastro-intestinal tolerance of the study product.

Collection of daily data about compliance with the study product i.e. actual versus prescribed intake.

Improve quality of life by increasing range of foods available for use in a ketogenic diet.

Study Timeline

• Study Start: 2016-04
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-09-19
• Study First Submitted QC: 2016-09-23
• Study First Posted: 2016-09-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• 3 years and over
• Confirmed diagnosis of intractable epilepsy or Glut-1 DS
• Children must be currently established on a KD for at least 3 months, taken orally
• Written, informed consent by participant/carer

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Consumption of Keyo	Keyo	Participants will consume their normal KD and take Keyo as advised by the lead dietitian.

Primary Outcome Measures

Name	Time	Method
GI tolerance daily diary	Days 1-7	Qualitative assessments from subject questionnaires that allow evaluation of the gastro-intestinal tolerance of the study product.
Product compliance daily diary	Days 1-7	Qualitative assessments from subject questionnaires that allow evaluation of compliance with the study product, i.e. actual versus prescribed intake.
Palatability questionnaire	Day 8	Qualitative assessment from subject questionnaire that allows evaluation of the palatability of the study product.
Ease of use daily diary	Days 1-7	Qualitative assessments from subject questionnaires that allow evaluation of the ease of use of the study product.

Trial Locations

Locations (2)

Leeds Teaching Hospitals NHS Trust; 🇬🇧 Leeds, West Yorkshire, United Kingdom

Central Manchester University Hospitals NHS Foundation Trust; 🇬🇧 Manchester, Greater Manchester, United Kingdom