Back to resultsEvaluation of Keyo in Children With Epilepsy (Keyo)
Primary Purpose
Intractable Epilepsy, Glucose Transporter Type 1 Deficiency Syndrome, Ketogenic Dieting
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Keyo
Sponsored by
About this trial
This is an interventional treatment trial for Intractable Epilepsy focused on measuring Epilepsy, Glut, Ketogenic, Glucose
Eligibility Criteria
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:
-
Sites / Locations
- Central Manchester University Hospitals NHS Foundation Trust
- Leeds Teaching Hospitals NHS Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Consumption of Keyo
Arm Description
Participants will consume their normal KD and take Keyo as advised by the lead dietitian.
Outcomes
Primary Outcome Measures
Palatability questionnaire
Qualitative assessment from subject questionnaire that allows evaluation of the palatability of the study product.
Ease of use daily diary
Qualitative assessments from subject questionnaires that allow evaluation of the ease of use of the study product.
GI tolerance daily diary
Qualitative assessments from subject questionnaires that allow evaluation of the gastro-intestinal tolerance of the study product.
Product compliance daily diary
Qualitative assessments from subject questionnaires that allow evaluation of compliance with the study product, i.e. actual versus prescribed intake.
Secondary Outcome Measures
Full Information
NCT ID
NCT02915211
First Posted
September 19, 2016
Last Updated
September 23, 2016
Sponsor
Vitaflo International, Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02915211
Brief Title
Evaluation of Keyo in Children With Epilepsy
Acronym
Keyo
Official Title
A Feasibility Study to Evaluate the Acceptability of Keyo, a Food for Special Medical Purposes (FSMP) for Use in the Ketogenic Diet (KD) With Regard to Product Tolerance, Compliance and Acceptability
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitaflo International, Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intractable Epilepsy, Glucose Transporter Type 1 Deficiency Syndrome, Ketogenic Dieting
Keywords
Epilepsy, Glut, Ketogenic, Glucose
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Consumption of Keyo
Arm Type
Experimental
Arm Description
Participants will consume their normal KD and take Keyo as advised by the lead dietitian.
Intervention Type
Dietary Supplement
Intervention Name(s)
Keyo
Intervention Description
Keyo is a Food for Special Medical Purposes (FSMP) and is intended for use in the KD. It has a fat to protein and carbohydrate ratio of 3 to 1. This makes it appropriate for inclusion in all versions of the KD - classical, MCT, MAD and LGI. Keyo has been designed as a nutritionally complete, ready to use, pleasant tasting and versatile medical food for use in a KD.
Primary Outcome Measure Information:
Title
Palatability questionnaire
Description
Qualitative assessment from subject questionnaire that allows evaluation of the palatability of the study product.
Time Frame
Day 8
Title
Ease of use daily diary
Description
Qualitative assessments from subject questionnaires that allow evaluation of the ease of use of the study product.
Time Frame
Days 1-7
Title
GI tolerance daily diary
Description
Qualitative assessments from subject questionnaires that allow evaluation of the gastro-intestinal tolerance of the study product.
Time Frame
Days 1-7
Title
Product compliance daily diary
Description
Qualitative assessments from subject questionnaires that allow evaluation of compliance with the study product, i.e. actual versus prescribed intake.
Time Frame
Days 1-7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen McCullagh, BSc, MBChB
Organizational Affiliation
Leeds Teaching Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Manchester University Hospitals NHS Foundation Trust
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Evaluation of Keyo in Children With Epilepsy
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