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Use of Betashot in Children and Adults With Epilepsy

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ClinicalTrials.gov Identifier: NCT02825745
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Nervous System Disorder Dietary Supplement: Betashot Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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.
Actual Study Start Date : June 29, 2016
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
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 Name: MCT based emulsion




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825745


Locations
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United Kingdom
National Hospital for Neurology and Neurosurgery
London, United Kingdom, WC1N 3BG
Great Ormond Street Hospital for Children
London, United Kingdom
Sponsors and Collaborators
Vitaflo International, Ltd
Investigators
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Principal Investigator: Matthew Walker UCL
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Responsible Party: Vitaflo International, Ltd
ClinicalTrials.gov Identifier: NCT02825745    
Other Study ID Numbers: MCT-BETS-14082015-01
181054 ( Other Identifier: IRAS )
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Epilepsy
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases