Nervous System Disorder
Conditions
Brief summary
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.
Detailed description
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: 1. Tolerance (side effects such as bloating or cramps) 2. Acceptability (flavour, texture, taste) 3. Compliance (how easy it is to use Betashot at the advised quantity, as part of their daily diet)
Interventions
DIETARY_SUPPLEMENTBetashot
Betashot is a Food for Special Medical Purposes (FSMP). Suitable for use from 3 years of age.
Sponsors
Vitaflo International, Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Children aged 3-18 years with symptoms of epilepsy continuing despite adequate levels of anti-epileptic medication, either with a diagnosis of Dravet syndrome or another early onset epilepsy, the result of a genetic mutation. Adults (aged over 18) with symptoms of epilepsy continuing despite adequate levels of anti-epileptic medication. 2. Participant/Parent/guardian to comply with the study protocol and participate in active monitoring of tolerance, acceptability and compliance of Betashot via a written record, and to complete questionnaires.
Exclusion criteria
1. Children \< 3 years of age 2. Children and adults free from epilepsy for \> 4 weeks 3. Medical conditions that contra-indicate the use of MCT 4. Inability to comply with the study protocol. 5. Currently on a ketogenic diet 6. Children and adults who are totally enterally fed. 7. Females who are pregnant or planning to become pregnant during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Palatability | 12 weeks | The primary outcome measure for the study is to determine, via a questionnaire, the palatability of Betashot |
| Gastrointestinal tolerance | 12 weeks | The primary outcome measure for the study is to determine, via a questionnaire, the GI tolerance of Betashot |
| Compliance | 12 weeks | The primary outcome measure for the study is to determine, via a questionnaire, the patient compliance with Betashot |
Countries
United Kingdom
Outcome results
None listed