Ketogenic DietingKrioNCT03202108
Evaluation of Krio in Children and Adults With Epilepsy
A study testing Krio in people with Ketogenic Dieting and Epilepsy, run by Vitaflo International, Ltd.
Trial summary
Acceptability study to evaluate the gastrointestinal tolerance, palatability and participant compliance, over a 7-day period, of Krio for the dietary management of participants with intractable epilepsy or Glut-1 deficiency syndrome patients on a ketogenic diet. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Ketogenic Dieting, Epilepsy, Glucose Transporter Type 1 Deficiency Syndrome
- What is being tested?
- Krio
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 11 May 2018to 28 Jun 2018
- 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
- Confirmed diagnosis of a condition requiring a KD, e.g. intractable epilepsy, Glut-1 DS.
- Aged three (3) years and over.
- Currently established on a KD for at least three (3) months, taken orally.
- Participant (or parent/guardian) considered by PI and dietitian to be fully proficient at managing the KD, and able to do this competently and accurately.
- Participant (or parent/guardian) considered by PI and dietitian to be able to follow the protocol requirements and complete the diary and questionnaire.
- Freely given, written, informed consent from patient or parent/guardian.
- Freely given, written assent (if appropriate).
Who cannot join
- Inability to comply with the study protocol, in the opinion of the investigator.
- Inability to comply with the ketogenic diet.
- Women who are pregnant / breastfeeding at the start of the study or planning to become pregnant during the study period.
- N.B.: Women who become pregnant unexpectedly during this study may, in consultation with their doctor, continue on the study's dietary product if they wish but will not have any investigations that would not normally be carried out during pregnancy.
About this study
Official title: A Feasibility Study to Evaluate the Acceptability of Krio, a Food for Special Medical Purposes (FSMP) for Use in the Ketogenic Diet (KD) With Regard to Product Tolerance, Compliance and Acceptability
Acceptability study to evaluate the gastrointestinal tolerance, palatability and participant compliance, over a 7-day period, of Krio for the dietary management of participants with intractable epilepsy or Glut-1 deficiency syndrome patients on a ketogenic diet.
Read the detailed description
This is a prospective, acceptability study in fifteen (15) participants aged three (3) years and over, who are established on a ketogenic diet (KD), of Krio to aid in the management of their diet.
Participants will be provided with a 7-day supply of Krio and will be asked to complete a daily diary and short questionnaire to record information allowing assessment the following:
- Gastrointestinal tolerance
- Palatability
- Compliance
Krio 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, medium chain triglyceride (MCT), modified Atkins diet (MAD) and low glycaemic index (LGI). It is suitable from 3 years of age.
Krio is presented as a ready to eat solid bar (28g), with no additional preparation required. It contains fat (20g per bar), protein and carbohydrate with added sweetener and flavourings. It does not contain any added micronutrients.
The recommended intake of the product for each participant will be determined by a dietitian. The quantity to be consumed daily will be recommended on an individual patient basis, but will be a minimum of 1 bar.
Product acceptability data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) for product registration.
- Being tested
- Krio
- Keywords
- Ketogenic, Diet, Epilepsy, Glut-1 DS, Krio
- Medical subject headings
- Epilepsy, Glut1 Deficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KrioDietary supplement
Krio is a ready to eat, chocolate-flavoured, solid bar containing 20g fat per 28g bar. It contains protein and carbohydrate with added sweetener and flavourings. It does not contain any added micronutrients. Krio is not for use as a sole source of nutrition.
It has a fat to protein and carbohydrate ratio of 3 to 1, making it suitable for use in all versions of the ketogenic diet.
This product is to be consumed daily under the direction of a dietitian.
| Study group | Role | What they receive |
|---|---|---|
| Consumption of Krio | Experimental | Incorporation of Krio into the daily diet. Receives: Dietary Supplement: Krio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Product compliance daily diary
Quantitative assessments from subject questionnaires that allow evaluation of compliance with the study product, i.e. actual versus prescribed intake.
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
Ease of use questionnaire
Qualitative assessment from subject questionnaire that allows evaluation of the ease of use of the study product.
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start11 May 2018
- Primary completion15 Jun 2018
- Study completion28 Jun 2018
Why it stopped: Product manufacturing issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ketogenic DietingStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitaflo International, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rachel Meskell, Principal investigator, Leeds Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202108
- Sponsor's protocol ID
- MCT-KRIO-2015-01-06
- Acronym
- Krio
- Status last verified
- Feb 2024
- First submitted
- 26 Jun 2017
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 to Evaluate the Acceptability of Krio, 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
- NCT03202108
- Acronym / sponsor ID
- Krio / MCT-KRIO-2015-01-06
- Keywords
- Ketogenic, Diet, Epilepsy, Glut-1 DS, Krio
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Product manufacturing issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vitaflo International, LtdIndustry (pharma, biotech, devices)
- Study start
- 11 May 2018 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 28 Jun 2017 (actual)
- 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.
Acceptability study to evaluate the gastrointestinal tolerance, palatability and participant compliance, over a 7-day period, of Krio for the dietary management of participants with intractable epilepsy or Glut-1 deficiency syndrome patients on a ketogenic diet.
Detailed description
This is a prospective, acceptability study in fifteen (15) participants aged three (3) years and over, who are established on a ketogenic diet (KD), of Krio to aid in the management of their diet.
Participants will be provided with a 7-day supply of Krio and will be asked to complete a daily diary and short questionnaire to record information allowing assessment the following:
- Gastrointestinal tolerance
- Palatability
- Compliance
Krio 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, medium chain triglyceride (MCT), modified Atkins diet (MAD) and low glycaemic index (LGI). It is suitable from 3 years of age.
Krio is presented as a ready to eat solid bar (28g), with no additional preparation required. It contains fat (20g per bar), protein and carbohydrate with added sweetener and flavourings. It does not contain any added micronutrients.
The recommended intake of the product for each participant will be determined by a dietitian. The quantity to be consumed daily will be recommended on an individual patient basis, but will be a minimum of 1 bar.
Product acceptability data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) for product registration.
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 Krio | Experimental | Dietary Supplement: KrioIncorporation of Krio into the daily diet. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed diagnosis of a condition requiring a KD, e.g. intractable epilepsy, Glut-1 DS.
- Aged three (3) years and over.
- Currently established on a KD for at least three (3) months, taken orally.
- Participant (or parent/guardian) considered by PI and dietitian to be fully proficient at managing the KD, and able to do this competently and accurately.
- Participant (or parent/guardian) considered by PI and dietitian to be able to follow the protocol requirements and complete the diary and questionnaire.
Key exclusion criteria (4 listed)
- Inability to comply with the study protocol, in the opinion of the investigator.
- Inability to comply with the ketogenic diet.
- Women who are pregnant / breastfeeding at the start of the study or planning to become pregnant during the study period.
- N.B.: Women who become pregnant unexpectedly during this study may, in consultation with their doctor, continue on the study's dietary product if they wish but will not have any investigations that would not normally be carried out during pregnancy.
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 |
|---|---|---|
| KrioKrio is a ready to eat, chocolate-flavoured, solid bar containing 20g fat per 28g bar. It contains protein and carbohydrate with added sweetener and flavourings. It does not contain any added micronutrients. Krio is not for use as a sole source of nutrition. It has a fat to protein and carbohydrate ratio of 3 to 1, making it suitable for use in all versions of the ketogenic diet. This product is to be consumed daily under the direction of a dietitian. | Dietary supplement | Consumption of Krio |
Primary outcome
Product compliance daily diary
Time frame: Days 1-7
Quantitative assessments from subject questionnaires that allow evaluation of compliance with the study product, i.e. actual versus prescribed intake.
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.
Ease of use questionnaire
Time frame: Day 8
Qualitative assessment from subject questionnaire that allows evaluation of the ease of use of the study product.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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.
Rachel Meskell principal investigator
Leeds Teaching Hospitals NHS Trust
Questions about this trial
What is this clinical trial studying?
A study testing Krio in people with Ketogenic Dieting and Epilepsy, run by Vitaflo International, Ltd.
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 7 inclusion and 4 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: withdrawn, 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Product compliance daily diary (time frame: Days 1-7). 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.