Evaluation of Keyo in Children With Epilepsy

Ketogenic Dieting Clinical Trial

— Keyo  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02915211
• Other study ID #: MCT-Keyo-11/12/15-01
• Secondary ID: 196542
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: June 2016

Study information

• Verified date: February 2024
• Source: Vitaflo International, Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Glucose Transporter Type 1 Deficiency Syndrome
• Intractable Epilepsy
• Ketogenic Dieting

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds	West Yorkshire
United Kingdom	Central Manchester University Hospitals NHS Foundation Trust	Manchester	Greater Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Vitaflo International, Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Palatability questionnaire	Qualitative assessment from subject questionnaire that allows evaluation of the palatability of the study product.	Day 8
Primary	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
Primary	GI tolerance daily diary	Qualitative assessments from subject questionnaires that allow evaluation of the gastro-intestinal tolerance of the study product.	Days 1-7
Primary	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