Evaluation of Ketoflo (NCT04399954) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Ketoflo
United Kingdom25 participantsStarted 2020-02-24
Plain-language 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.
Who can participate
Age range
3 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested something called Ketoflo for conditions like intractable epilepsy and Glucose Transporter Type 1 Deficiency Syndrome — could you tell me whether Ketoflo might be relevant to my specific diagnosis, and whether its results are published anywhere we could review together?
2The trial measured gastrointestinal tolerance over just four weeks — does that short timeframe give us enough safety and tolerability information to understand how my body might respond to this kind of ketogenic formula long-term?
3Since this study tracked seizure frequency as one of its outcomes, what did the results actually show, and how does that compare to what I might expect from a standard ketogenic diet approach already available to me?
4The trial looked at ketone levels as a marker of nutritional suitability — can you help me understand what achieving the right ketone levels would actually mean for managing my condition, and whether that's something we could monitor if I tried a ketogenic approach?
5Before considering anything from this completed trial, should we first talk about whether a conventional ketogenic diet managed by a dietitian is the right starting point for me, rather than a newer formula product?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in gastrointestinal tolerance from week 1 to week 4