Intractable EpilepsyKeyoNCT02915211
Evaluation of Keyo in Children With Epilepsy
A study testing Keyo in people with Intractable Epilepsy and Glucose Transporter Type 1 Deficiency Syndrome, run by Vitaflo International, Ltd at 2 sites in United Kingdom.
Trial summary
To evaluate the tolerance, acceptability and compliance of Keyo in 20 subjects aged 3 years and over, with intractable epilepsy or Glut-1 DS on a KD. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Intractable Epilepsy, Glucose Transporter Type 1 Deficiency Syndrome, Ketogenic Dieting
- What is being tested?
- Keyo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2016to Jun 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 3 years and over
- Confirmed diagnosis of intractable epilepsy or Glut-1 DS
- Children must be currently established on a KD for at least 3 months, taken orally
- Written, informed consent by participant/carer
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS1 3EX
Central Manchester University Hospitals NHS Foundation Trust
Manchester, Greater Manchester, M13 9WL
About this study
Official title: A Feasibility Study to Evaluate the Acceptability of Keyo, a Food for Special Medical Purposes (FSMP) for Use in the Ketogenic Diet (KD) With Regard to Product Tolerance, Compliance and Acceptability
To evaluate the tolerance, acceptability and compliance of Keyo in 20 subjects aged 3 years and over, with intractable epilepsy or Glut-1 DS on a KD.
Read the detailed description
Qualitative assessments from subject questionnaires that allow evaluation of the acceptability and ease of use of the study product.
Collection of daily data about the gastro-intestinal tolerance of the study product.
Collection of daily data about compliance with the study product i.e. actual versus prescribed intake.
Improve quality of life by increasing range of foods available for use in a ketogenic diet.
- Being tested
- Keyo
- Keywords
- Epilepsy, Glut, Ketogenic, Glucose
- Medical subject headings
- Drug Resistant Epilepsy, Glut1 Deficiency Syndrome, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KeyoDietary supplement
Keyo is a Food for Special Medical Purposes (FSMP) and is intended for use in the KD. It has a fat to protein and carbohydrate ratio of 3 to 1. This makes it appropriate for inclusion in all versions of the KD - classical, MCT, MAD and LGI. Keyo has been designed as a nutritionally complete, ready to use, pleasant tasting and versatile medical food for use in a KD.
| Study group | Role | What they receive |
|---|---|---|
| Consumption of Keyo | Experimental | Participants will consume their normal KD and take Keyo as advised by the lead dietitian. Receives: Dietary Supplement: Keyo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palatability questionnaire
Qualitative assessment from subject questionnaire that allows evaluation of the palatability of the study product.
Measured: Day 8
Ease of use daily diary
Qualitative assessments from subject questionnaires that allow evaluation of the ease of use of the study product.
Measured: Days 1-7
GI tolerance daily diary
Qualitative assessments from subject questionnaires that allow evaluation of the gastro-intestinal tolerance of the study product.
Measured: Days 1-7
Product compliance daily diary
Qualitative assessments from subject questionnaires that allow evaluation of compliance with the study product, i.e. actual versus prescribed intake.
Measured: Days 1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intractable EpilepsyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitaflo International, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helen McCullagh, BSc, MBChB, Principal investigator, Leeds Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915211
- Sponsor's protocol ID
- MCT-Keyo-11/12/15-01
- Other IDs
- 196542
- Acronym
- Keyo
- Status last verified
- Feb 2024
- First submitted
- 19 Sep 2016
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 to Evaluate the Acceptability of Keyo, a Food for Special Medical Purposes (FSMP) for Use in the Ketogenic Diet (KD) With Regard to Product Tolerance, Compliance and Acceptability
- ClinicalTrials.gov ID
- NCT02915211
- Acronym / sponsor ID
- Keyo / MCT-Keyo-11/12/15-01
- Keywords
- Epilepsy, Glut, Ketogenic, Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Vitaflo International, LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Sep 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.
To evaluate the tolerance, acceptability and compliance of Keyo in 20 subjects aged 3 years and over, with intractable epilepsy or Glut-1 DS on a KD.
Detailed description
Qualitative assessments from subject questionnaires that allow evaluation of the acceptability and ease of use of the study product.
Collection of daily data about the gastro-intestinal tolerance of the study product.
Collection of daily data about compliance with the study product i.e. actual versus prescribed intake.
Improve quality of life by increasing range of foods available for use in a ketogenic diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consumption of Keyo | Experimental | Dietary Supplement: KeyoParticipants will consume their normal KD and take Keyo as advised by the lead dietitian. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 3 years and over
- Confirmed diagnosis of intractable epilepsy or Glut-1 DS
- Children must be currently established on a KD for at least 3 months, taken orally
- Written, informed consent by participant/carer
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| KeyoKeyo is a Food for Special Medical Purposes (FSMP) and is intended for use in the KD. It has a fat to protein and carbohydrate ratio of 3 to 1. This makes it appropriate for inclusion in all versions of the KD - classical, MCT, MAD and LGI. Keyo has been designed as a nutritionally complete, ready to use, pleasant tasting and versatile medical food for use in a KD. | Dietary supplement | Consumption of Keyo |
Primary outcome
Palatability questionnaire
Time frame: Day 8
Qualitative assessment from subject questionnaire that allows evaluation of the palatability of the study product.
Ease of use daily diary
Time frame: Days 1-7
Qualitative assessments from subject questionnaires that allow evaluation of the ease of use of the study product.
GI tolerance daily diary
Time frame: Days 1-7
Qualitative assessments from subject questionnaires that allow evaluation of the gastro-intestinal tolerance of the study product.
Product compliance daily diary
Time frame: Days 1-7
Qualitative assessments from subject questionnaires that allow evaluation of compliance with the study product, i.e. actual versus prescribed intake.
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: Undecided
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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.
Helen McCullagh, BSc, MBChB principal investigator
Leeds Teaching Hospitals NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Keyo in people with Intractable Epilepsy and Glucose Transporter Type 1 Deficiency Syndrome, 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 4 inclusion and 1 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 questionnaire (time frame: Day 8). The study lists 4 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.