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Completed

NCT Number: NCT02825745

Use of Betashot 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.

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Key information

Conditions

Nervous System Disorder Nervous System Diseases

Age range

3 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Great Ormond Street Hospital for Children, London, United Kingdom

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About this study

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:

  • Tolerance (side effects such as bloating or cramps)
  • Acceptability (flavour, texture, taste)
  • Compliance (how easy it is to use Betashot at the advised quantity, as part of their daily diet)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

  • 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

  • Children < 3 years of age
  • Children and adults free from epilepsy for > 4 weeks
  • Medical conditions that contra-indicate the use of MCT
  • Inability to comply with the study protocol.
  • Currently on a ketogenic diet
  • Children and adults who are totally enterally fed.
  • Females who are pregnant or planning to become pregnant during the study.

Treatment and study plan

Betashot

Dietary Supplement

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

Other names: MCT based emulsion

Primary outcomes

  1. Palatability

    Time frame: 12 weeks

    The primary outcome measure for the study is to determine, via a questionnaire, the palatability of Betashot

  2. Gastrointestinal tolerance

    Time frame: 12 weeks

    The primary outcome measure for the study is to determine, via a questionnaire, the GI tolerance of Betashot

  3. Compliance

    Time frame: 12 weeks

    The primary outcome measure for the study is to determine, via a questionnaire, the patient compliance with Betashot

Sponsors and collaborators

Lead sponsor

Vitaflo International, Ltd

Industry

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 7, 2016
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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