Evaluation of Keyo in Children With Epilepsy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Dietary Supplement: Keyo


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Consumption of Keyo<br>Participants will consume their normal KD and take Keyo as advised by the lead dietitian. | Dietary Supplement: Keyo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glut, Epilepsy, Ketogenic, Glucose