Use of Betashot in Children and Adults With Epilepsy

Nervous System Disorder Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825745
• Other study ID #: MCT-BETS-14082015-01
• Secondary ID: 181054
• Status: Completed
• Phase: N/A
• Start date: June 29, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2024
• Source: Vitaflo International, Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Nervous System Diseases
• Nervous System Disorder

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital for Children	London
United Kingdom	National Hospital for Neurology and Neurosurgery	London

Sponsors (1)

Lead Sponsor	Collaborator
Vitaflo International, Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Palatability	The primary outcome measure for the study is to determine, via a questionnaire, the palatability of Betashot	12 weeks
Primary	Gastrointestinal tolerance	The primary outcome measure for the study is to determine, via a questionnaire, the GI tolerance of Betashot	12 weeks
Primary	Compliance	The primary outcome measure for the study is to determine, via a questionnaire, the patient compliance with Betashot	12 weeks

External Links

•   Brain Communications, Volume 3, Issue 4, 2021, fcab160, Published 23 July 2021