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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
First received
Last updated
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
Health authority
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: -

Study Design


Related Conditions & MeSH terms


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
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