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Completed

NCT Number: NCT02915211

Evaluation of Keyo in Children With Epilepsy

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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Key information

Conditions

Intractable Epilepsy Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Epilepsy Glucose Transporter Type 1 Deficiency Syndrome Glut1 Deficiency Syndrome Ketogenic Dieting Nervous System Diseases

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Manchester University Hospitals NHS Foundation Trust, Manchester, Greater Manchester, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Keyo

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.

Primary outcomes

  1. Palatability questionnaire

    Time frame: Day 8

    Qualitative assessment from subject questionnaire that allows evaluation of the palatability of the study product.

  2. Ease of use daily diary

    Time frame: Days 1-7

    Qualitative assessments from subject questionnaires that allow evaluation of the ease of use of the study product.

  3. GI tolerance daily diary

    Time frame: Days 1-7

    Qualitative assessments from subject questionnaires that allow evaluation of the gastro-intestinal tolerance of the study product.

  4. Product compliance daily diary

    Time frame: Days 1-7

    Qualitative assessments from subject questionnaires that allow evaluation of compliance with the study product, i.e. actual versus prescribed intake.

Sponsors and collaborators

Lead sponsor

Vitaflo International, Ltd

Industry

Registry information

Official study 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

Acronym: Keyo

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 26, 2016
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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