Use of Betashot in Children and Adults With Epilepsy

Not Applicable

Completed

• Conditions: Nervous System Disorder
• Interventions: Dietary Supplement: Betashot

• Registration Number: NCT02825745
• Lead Sponsor: Vitaflo International, Ltd

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)

Study Timeline

• Study First Submitted: 2015-09-07
• Study Start: 2016-06-29
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-07
• Primary Completion: 2019-05-31
• Study Completion: 2019-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Betashot	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Great Ormond Street Hospital for Children; 🇬🇧 London, United Kingdom

National Hospital for Neurology and Neurosurgery; 🇬🇧 London, United Kingdom