Evaluation of Keyo in Children With Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-06-30

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.

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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.

Conditions

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Intractable Epilepsy Glucose Transporter Type 1 Deficiency Syndrome Ketogenic Dieting

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Consumption of Keyo

Participants will consume their normal KD and take Keyo as advised by the lead dietitian.

Group Type EXPERIMENTAL

Keyo

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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Keyo

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.

Intervention Type DIETARY_SUPPLEMENT

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