Use of Betashot in Children and Adults With Epilepsy

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.

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.

Study Overview

• Status: Completed
• Conditions: Nervous System Disorder
• Intervention / Treatment: Dietary supplement: Betashot

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)

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC1N 3BG
    • National Hospital For Neurology and Neurosurgery
  • London, United Kingdom
    • Great Ormond Street Hospital for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Dietary supplement: Betashot; Betashot is a Food for Special Medical Purposes (FSMP). Suitable for use from 3 years of age.; Other Names: MCT based emulsion

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vitaflo International, Ltd
• Investigators: Principal Investigator: Matthew Walker, UCL

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2016
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: September 7, 2015
• First Submitted That Met QC Criteria: July 1, 2016
• First Posted (Estimated): July 7, 2016

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Epilepsy; Nervous System Diseases
• Other Study ID Numbers: MCT-BETS-14082015-01; 181054 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO