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Use of Betashot in Children and Adults With Epilepsy

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Vitaflo

Status

Completed

Conditions

Nervous System Disorder

Treatments

Dietary Supplement: Betashot

Study type

Interventional

Funder types

Industry

Identifiers

NCT02825745
181054 (Other Identifier)
MCT-BETS-14082015-01

Details and patient eligibility

About

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.

Full 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)

Enrollment

77 patients

Sex

All

Ages

3 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

77 participants in 1 patient group

Betashot
Other group
Description:
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.
Treatment:
Dietary Supplement: Betashot

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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