Use of Betashot in Children and Adults With Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-29

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Nervous System Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Betashot

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.

Group Type OTHER

Betashot

Intervention Type DIETARY_SUPPLEMENT

Betashot is a Food for Special Medical Purposes (FSMP). Suitable for use from 3 years of age.

Interventions

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Betashot

Betashot is a Food for Special Medical Purposes (FSMP). Suitable for use from 3 years of age.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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MCT based emulsion

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No