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Evaluation of Ketoflo

NCT04399954 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-02-15

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Vitaflo International, Ltd

    lead INDUSTRY

Principal Investigators

  • Kathryn Lightfoot · Leeds Teaching Hospitals NHS Trust

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-24
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04399954 on ClinicalTrials.gov