Evaluation of Keyo in Children With Epilepsy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02915211

Acronym

Keyo

Enrollment

Registered

2016-09-26

Start date

2016-04-30

Completion date

2016-06-30

Last updated

2024-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucose Transporter Type 1 Deficiency Syndrome, Intractable Epilepsy, Ketogenic Dieting

Keywords

Epilepsy, Glut, Ketogenic, Glucose

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.

Interventions

DIETARY_SUPPLEMENTKeyo

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026