Evaluation of Krio in Children and Adults With Epilepsy (Krio)
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|ClinicalTrials.gov Identifier: NCT03202108|
Recruitment Status : Withdrawn (Product manufacturing issues.)
First Posted : June 28, 2017
Last Update Posted : November 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ketogenic Dieting Epilepsy Glucose Transporter Type 1 Deficiency Syndrome||Dietary Supplement: Krio||Not Applicable|
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
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 11, 2018|
|Actual Primary Completion Date :||June 15, 2018|
|Actual Study Completion Date :||June 28, 2018|
Experimental: Consumption of Krio
Incorporation of Krio into the daily diet.
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.
- Product compliance daily diary [ Time Frame: Days 1-7 ]Quantitative assessments from subject questionnaires that allow evaluation of compliance with the study product, i.e. actual versus prescribed intake.
- 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.
- Ease of use questionnaire [ Time Frame: Day 8 ]Qualitative assessment from subject questionnaire that allows evaluation of the ease of use of the study product.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202108
|Principal Investigator:||Rachel Meskell||Leeds Teaching Hospitals NHS Trust|