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Use of Betashot in Children and Adults With Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 7, 2015
First Posted Date  ICMJE July 7, 2016
Last Update Posted Date May 19, 2020
Actual Study Start Date  ICMJE June 29, 2016
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2016)
  • Palatability [ Time Frame: 12 weeks ]
    The primary outcome measure for the study is to determine, via a questionnaire, the palatability of Betashot
  • Gastrointestinal tolerance [ Time Frame: 12 weeks ]
    The primary outcome measure for the study is to determine, via a questionnaire, the GI tolerance of Betashot
  • Compliance [ Time Frame: 12 weeks ]
    The primary outcome measure for the study is to determine, via a questionnaire, the patient compliance with Betashot
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2016)
  • Palatability [ Time Frame: 12 weeks ]
    The primary outcome measure for the study is to determine, via questionnaires, the palatability of Betashot
  • Gastrointestinal tolerance [ Time Frame: 12 weeks ]
    The primary outcome measure for the study is to determine, via questionnaires, the GI tolerance of Betashot
  • Compliance [ Time Frame: 12 weeks ]
    The primary outcome measure for the study is to determine, via questionnaires, the patient compliance with Betashot
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Betashot in Children and Adults With Epilepsy
Official Title  ICMJE 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Nervous System Disorder
Intervention  ICMJE 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
Study Arms  ICMJE 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.

Intervention: Dietary Supplement: Betashot
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 6, 2018)
78
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2016)
80
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02825745
Other Study ID Numbers  ICMJE MCT-BETS-14082015-01
181054 ( Other Identifier: IRAS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Vitaflo International, Ltd
Study Sponsor  ICMJE Vitaflo International, Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthew Walker UCL
PRS Account Vitaflo International, Ltd
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP