Evaluation of Krio in Children and Adults With Epilepsy — Krio  

Epilepsy Clinical Trial

Official title: A Feasibility Study to Evaluate the Acceptability of Krio, a Food for Special Medical Purposes (FSMP) for Use in the Ketogenic Diet (KD) With Regard to Product Tolerance, Compliance and Acceptability

Status Withdrawn

Clinical Trial Summary

Acceptability study to evaluate the gastrointestinal tolerance, palatability and participant compliance, over a 7-day period, of Krio for the dietary management of participants with intractable epilepsy or Glut-1 deficiency syndrome patients on a ketogenic diet.

Clinical Trial Description

This is a prospective, acceptability study in fifteen (15) participants aged three (3) years and over, who are established on a ketogenic diet (KD), of Krio to aid in the management of their diet.

Participants will be provided with a 7-day supply of Krio and will be asked to complete a daily diary and short questionnaire to record information allowing assessment the following:

• Gastrointestinal tolerance

• Palatability

• Compliance

Krio 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, medium chain triglyceride (MCT), modified Atkins diet (MAD) and low glycaemic index (LGI). It is suitable from 3 years of age.

Krio is presented as a ready to eat solid bar (28g), with no additional preparation required. It contains fat (20g per bar), protein and carbohydrate with added sweetener and flavourings. It does not contain any added micronutrients.

The recommended intake of the product for each participant will be determined by a dietitian. The quantity to be consumed daily will be recommended on an individual patient basis, but will be a minimum of 1 bar.

Product acceptability data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) for product registration. ;

Related Conditions & MeSH terms

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

• NCT number: NCT03202108
• Study type: Interventional
• Source: Vitaflo International, Ltd
• Status: Withdrawn
• Phase: N/A
• Start date: May 11, 2018
• Completion date: June 28, 2018