Nervous System DisorderNCT02825745
Use of Betashot in Children and Adults With Epilepsy
A study testing Betashot in people with Nervous System Disorder, run by Vitaflo International, Ltd at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 75 years
- Conditions the study is for
- Nervous System Disorder
- What is being tested?
- Betashot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 29 Jun 2016to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
National Hospital for Neurology and Neurosurgery
London, WC1N 3BG
Great Ormond Street Hospital for Children
London
About this study
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.
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.
Read the 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:
- 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)
- Conditions
- Nervous System Disorder
- Being tested
- Betashot
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetashotDietary supplement
Also called MCT based emulsion
Betashot is a Food for Special Medical Purposes (FSMP). Suitable for use from 3 years of age.
| Study group | Role | What they receive |
|---|---|---|
| Betashot | Other | 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. Receives: Dietary Supplement: Betashot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palatability
The primary outcome measure for the study is to determine, via a questionnaire, the palatability of Betashot
Measured: 12 weeks
Gastrointestinal tolerance
The primary outcome measure for the study is to determine, via a questionnaire, the GI tolerance of Betashot
Measured: 12 weeks
Compliance
The primary outcome measure for the study is to determine, via a questionnaire, the patient compliance with Betashot
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start29 Jun 2016
- Primary completion31 May 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nervous System DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitaflo International, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Walker, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825745
- Sponsor's protocol ID
- MCT-BETS-14082015-01
- Other IDs
- 181054
- Status last verified
- Feb 2024
- First submitted
- 7 Sep 2015
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02825745
- Acronym / sponsor ID
- MCT-BETS-14082015-01
- Conditions
- Nervous System Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Vitaflo International, LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2016 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Betashot | Other | Dietary Supplement: BetashotChildren: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. |
Who may qualify
- Ages
- 3 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BetashotAlso: MCT based emulsionBetashot is a Food for Special Medical Purposes (FSMP). Suitable for use from 3 years of age. | Dietary supplement | Betashot |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Walker principal investigator
UCL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betashot in people with Nervous System Disorder, run by Vitaflo International, Ltd at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Palatability (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.