NCT02915211

Evaluation of Keyo in Children With Epilepsy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Vitaflo International, Ltd · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-09-26
• Last updated: 2024-02-16

Locations

2 sites across 1 country: United Kingdom