NCT03202108

Evaluation of Krio in Children and Adults With Epilepsy

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• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Vitaflo International, Ltd · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Krio	Krio is a ready to eat, chocolate-flavoured, solid bar containing 20g fat per 28g bar. It contains protein and carbohydrate with added sweetener and flavourings. It does not contain any added micronutrients. Krio is not for use as a sole source of nutrition. It has a fat to protein and carbohydrate ratio of 3 to 1, making it suitable for use in all versions of the ketogenic diet. This product is to be consumed daily under the direction of a dietitian.

Timeline

• Start date: 2018-05-11
• Primary completion: 2018-06-15
• Completion: 2018-06-28
• First posted: 2017-06-28
• Last updated: 2024-02-16