Clinical Trial: Evaluation of Keyo in Children With Epilepsy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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.

Sponsor: Vitaflo International, Ltd

Current Primary Outcome:

• Palatability questionnaire [ Time Frame: Day 8 ]
  Qualitative assessment from subject questionnaire that allows evaluation of the palatability of the study product.
• 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.
• 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.
• 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Vitaflo International, Ltd

Dates:
Date Received: September 19, 2016
Date Started: April 2016
Date Completion:
Last Updated: September 23, 2016
Last Verified: September 2016