Evaluation of Ketoflo

NCT04399954 | Completed

• 3 other identifiers: MCT-KFLO-2018-02-1923238619/NW/0018
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Epilepsy Intractable; Glucose Transporter Type 1 Deficiency Syndrome; Ketogenic Dieting

Outcome Measures

Primary Outcomes (5)

• 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.

• Adherence

  Participants will record the amount of Ketoflo taken each day compared to the amount recommended by their dietitian.

  Days 1 - 28.

• 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.

• 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

• 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

Study Arms (1)

Ketoflo

EXPERIMENTAL

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.

Dietary Supplement: Ketoflo

Interventions

Ketoflo 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.

Ketoflo

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vitaflo International, Ltd: lead

Study Sites (5)

Royal Aberdeen Children's Hospital

Aberdeen, AB25 2ZG, United Kingdom

Location

Barberry

Birmingham, B15 2SY, United Kingdom

Location

Bristol Royal Hospital for Children

Bristol, BS2 8BJ, United Kingdom

Location

Leeds Children's Hospital

Leeds, LS1 3EX, United Kingdom

Location

Great Ormond Street Hospital for Children

London, WC1N 3JH, United Kingdom

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy; Glut1 Deficiency Syndrome

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Kathryn Lightfoot

  Leeds Teaching Hospitals NHS Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking, product will be given open label.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group - all patients to receive Ketoflo.

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 22, 2020
• Study Start: February 24, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)