Use of Betashot in Children and Adults With Epilepsy
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|ClinicalTrials.gov Identifier: NCT02825745|
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : May 19, 2020
In brief, this research is a prospective, feasibility study to evaluate the use of Betashot- a medium chain triglyceride- based (MCT) food for special medical purposes (FSMP) in children and adults diagnosed with epilepsy.
MCT is a type of dietary fat used in the ketogenic diet.
|Condition or disease||Intervention/treatment||Phase|
|Nervous System Disorder||Dietary Supplement: Betashot||Not Applicable|
This study aims to explore the use of Betashot in a group of children and adults with epilepsy who are consuming their normal diets, but limiting intakes of foods high in carbohydrate and sugars.
The participants will be required to drink Betashot to enable the following assessment:
- Tolerance (side effects such as bloating or cramps)
- Acceptability (flavour, texture, taste)
- Compliance (how easy it is to use Betashot at the advised quantity, as part of their daily diet)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study of the Use of Betashot, a Medium Chain Triglyceride- Based (MCT) Food for Special Medical Purposes (FSMP) in Children and Adults With Epilepsy.|
|Actual Study Start Date :||June 29, 2016|
|Actual Primary Completion Date :||May 31, 2019|
|Actual Study Completion Date :||December 31, 2019|
Children:will take Betashot as a proportion of their daily energy requirements calculated from the dietary information obtained during Visit A for up to 12 weeks.
Adults:will introduce Betashot and increase the amount taken in ml incrementally for up to 12 weeks.
Dietary Supplement: Betashot
Betashot is a Food for Special Medical Purposes (FSMP). Suitable for use from 3 years of age.
Other Name: MCT based emulsion
- Palatability [ Time Frame: 12 weeks ]The primary outcome measure for the study is to determine, via a questionnaire, the palatability of Betashot
- Gastrointestinal tolerance [ Time Frame: 12 weeks ]The primary outcome measure for the study is to determine, via a questionnaire, the GI tolerance of Betashot
- Compliance [ Time Frame: 12 weeks ]The primary outcome measure for the study is to determine, via a questionnaire, the patient compliance with Betashot
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): NCT02825745
|National Hospital for Neurology and Neurosurgery|
|London, United Kingdom, WC1N 3BG|
|Great Ormond Street Hospital for Children|
|London, United Kingdom|
|Principal Investigator:||Matthew Walker||UCL|