Evaluation of Ketoflo

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-24

Study Completion Date

2023-06-30

Brief Summary

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For 28 days, 30 participants aged 3 to 18 years of age (inclusive) with a condition requiring a ketogenic diet will incorporate Ketoflo into their usual dietary regime. Ketoflo is a nutritionally complete Food For Special Medical Purposes and is suitable for administration by both tube feeding and use as a sip feed. Data on gastrointestinal tolerance, participants adherence to recommended intakes and their thoughts on the product's palatability will be self-reported in Daily Study Diaries.

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Detailed Description

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This is a 28-day prospective study to evaluate the acceptability of Ketoflo, in terms of GI tolerance, adherence to recommended intakes and palatability. The product's nutritional suitability for use in a ketogenic diet will also be evaluated by recording ketone levels and seizure frequency measured as part of usual clinical care.

Ketoflo is nutritionally complete liquid feed for use in the dietary management of epilepsy or other neurometabolic conditions requiring a ketogenic diet. It is designed to be nutritionally complete from 3-18 years and can be used as a supplementary feed thereafter.

Ketoflo has been designed in liaison with Key Opinion Leaders and will offer an additional choice of prescribe-able feeds for use in the ketogenic diet.

The study will involve 30 participants, aged between three and eighteen years of age (inclusive), who are already established on a ketogenic diet for at least three months before the study begins.

Participants will self-report data in Daily Study Diaries over the course of the study. Data will also be collected by the Investigators in Baseline CRFs and End of Study CRFs for all participants. Any data collected for the study will be anonymised before being relayed to the sponsor.

The data generated by the trial will be used to support a submission by Vitaflo (International) Ltd. to the Advisory Committee on Borderline Substances (ACBS) for Ketoflo to become reimbursable on prescription in the UK. The data will also be used in a submission to the General Medical Services in the Republic of Ireland.

Conditions

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Epilepsy Intractable Glucose Transporter Type 1 Deficiency Syndrome Ketogenic Dieting

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group - all patients to receive Ketoflo.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

No masking, product will be given open label.

Study Groups

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Ketoflo

Ketoflo to be incorporated into each participant's usual ketogenic diet for 28 days. Amount taken and frequency of intake to be determined by the dietitian.

Group Type EXPERIMENTAL

Ketoflo

Intervention Type DIETARY_SUPPLEMENT

Ketoflo is a ready to use liquid feed for the dietary management of epilepsy and other conditions that may require a ketogenic diet. It has a 4:1 ratio of fat to carbohydrate and protein and can be administered enterally via a tube feeding or oral consumption.

Interventions

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Ketoflo

Ketoflo is a ready to use liquid feed for the dietary management of epilepsy and other conditions that may require a ketogenic diet. It has a 4:1 ratio of fat to carbohydrate and protein and can be administered enterally via a tube feeding or oral consumption.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

i) Diagnosis of a condition requiring a ketogenic diet (KD) e.g. intractable epilepsy, Glut-1 deficiency syndrome (Glut-1 DS) etc.

ii) Aged 3 - 18 years of age (inclusive).

iii) Established on a ketogenic diet for at least 3 months under the supervision of a clinician and/or dietitian trained in the use of the KD.

iv) Requirement for a liquid ketogenic feed.

v) In the opinion of the investigator, the participant (and parent/guardian, if relevant) is/are able to comply with the study protocol requirements and complete the diary and questionnaire.

vi) Willingly given, written, informed consent from participant (or parent/guardian, if relevant)

vii) Willingly given, written assent (if appropriate).

Exclusion Criteria

i) Inability to comply with the study protocol, in the opinion of the investigator.

ii) Under 3 years of age or over 18 years of age.

iii) Medical conditions in which the KD is contraindicated.

iv) Previous clinical evaluation indicating unsuitability for the KD.

Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No