Evaluation of Keyo in Children With Epilepsy
Keyo
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
2 other identifiers
interventional
17
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2016
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 19, 2016
CompletedFirst Posted
Study publicly available on registry
September 26, 2016
CompletedFebruary 16, 2024
February 1, 2024
2 months
September 19, 2016
February 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Palatability questionnaire
Qualitative assessment from subject questionnaire that allows evaluation of the palatability of the study product.
Day 8
Ease of use daily diary
Qualitative assessments from subject questionnaires that allow evaluation of the ease of use of the study product.
Days 1-7
GI tolerance daily diary
Qualitative assessments from subject questionnaires that allow evaluation of the gastro-intestinal tolerance of the study product.
Days 1-7
Product compliance daily diary
Qualitative assessments from subject questionnaires that allow evaluation of compliance with the study product, i.e. actual versus prescribed intake.
Days 1-7
Study Arms (1)
Consumption of Keyo
EXPERIMENTALParticipants will consume their normal KD and take Keyo as advised by the lead dietitian.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Central Manchester University Hospitals NHS Foundation Trust
Manchester, Greater Manchester, M13 9WL, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS1 3EX, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helen McCullagh, BSc, MBChB
Leeds Teaching Hospitals NHS Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2016
First Posted
September 26, 2016
Study Start
April 1, 2016
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
February 16, 2024
Record last verified: 2024-02