Evaluation of Ketoflo

Ketogenic Dieting Clinical Trial

— Ketoflo  

Official title:

A Study to Evaluate the Acceptability of Ketoflo, a Food for Special Medical Purposes (FSMP) for Use in the Dietary Management of Epilepsy or Neurometabolic Conditions Requiring a Ketogenic Diet (KD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04399954
• Other study ID #: MCT-KFLO-2018-02-19
• Secondary ID: 23238619/NW/0018
• Status: Completed
• Phase: N/A
• Start date: February 24, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2024
• Source: Vitaflo International, Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Epilepsy Intractable
• Glucose Transporter Type 1 Deficiency Syndrome
• Ketogenic Dieting

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
United Kingdom	Royal Aberdeen Children's Hospital	Aberdeen
United Kingdom	Barberry	Birmingham
United Kingdom	Bristol Royal Hospital for Children	Bristol
United Kingdom	Leeds Children's Hospital	Leeds
United Kingdom	Great Ormond Street Hospital for Children	London

Sponsors (1)

Lead Sponsor	Collaborator
Vitaflo International, Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gastrointestinal tolerance from week 1 to week 4	Participants will self-report any gastrointestinal symptoms experienced over the course of the study in Daily Study Diaries.	Days 1 - 7 and days 21 - 28.
Primary	Adherence	Participants will record the amount of Ketoflo taken each day compared to the amount recommended by their dietitian.	Days 1 - 28.
Primary	Palatability and ease of use	Participants will answer questions relating to Ketoflo's palatability and ease of use following the end of the study.	Day 28.
Primary	Nutritional suitability: ketone levels	Ketoflo's nutritional suitability will be assessed by evaluating ketone levels (mmol/l) recorded by participants as part of routine care. These data will be recorded in the Daily Study Diaries.	Days 1 - 28
Primary	Nutritional suitability: seizure frequency	Ketoflo's nutritional suitability will be assessed by evaluating seizure frequency (number per day) recorded by participants as part of routine care. These data will be recorded in the Daily Study Diaries.	Days 1 - 28