Evaluation of Keyo in Children With Epilepsy (Keyo)
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|ClinicalTrials.gov Identifier: NCT02915211|
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : September 26, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Intractable Epilepsy Glucose Transporter Type 1 Deficiency Syndrome Ketogenic Dieting||Dietary Supplement: Keyo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Consumption of Keyo
Participants will consume their normal KD and take Keyo as advised by the lead dietitian.
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.
- 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.
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|Ages Eligible for Study:||3 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 3 years and over
- Confirmed diagnosis of intractable epilepsy or Glut-1 DS
- Children must be currently established on a KD for at least 3 months, taken orally
- Written, informed consent by participant/carer
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): NCT02915211
|Central Manchester University Hospitals NHS Foundation Trust|
|Manchester, Greater Manchester, United Kingdom, M13 9WL|
|Leeds Teaching Hospitals NHS Trust|
|Leeds, West Yorkshire, United Kingdom, LS1 3EX|
|Principal Investigator:||Helen McCullagh, BSc, MBChB||Leeds Teaching Hospitals NHS Trust|
|Responsible Party:||Vitaflo International, Ltd|
|Other Study ID Numbers:||
196542 ( Other Identifier: IRAS )
|First Posted:||September 26, 2016 Key Record Dates|
|Last Update Posted:||September 26, 2016|
|Last Verified:||September 2016|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
Drug Resistant Epilepsy
Central Nervous System Diseases
Nervous System Diseases