Ketogenic Dieting Clinical Trial
— KeyoOfficial title:
A Feasibility Study to Evaluate the Acceptability of Keyo, a Food for Special Medical Purposes (FSMP) for Use in the Ketogenic Diet (KD) With Regard to Product Tolerance, Compliance and Acceptability
Verified date | February 2024 |
Source | Vitaflo International, Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the tolerance, acceptability and compliance of Keyo in 20 subjects aged 3 years and over, with intractable epilepsy or Glut-1 DS on a KD.
Status | Completed |
Enrollment | 17 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years and older |
Eligibility | Inclusion Criteria: - 3 years and over - Confirmed diagnosis of intractable epilepsy or Glut-1 DS - Children must be currently established on a KD for at least 3 months, taken orally - Written, informed consent by participant/carer Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Leeds Teaching Hospitals NHS Trust | Leeds | West Yorkshire |
United Kingdom | Central Manchester University Hospitals NHS Foundation Trust | Manchester | Greater Manchester |
Lead Sponsor | Collaborator |
---|---|
Vitaflo International, Ltd |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Palatability questionnaire | Qualitative assessment from subject questionnaire that allows evaluation of the palatability of the study product. | Day 8 | |
Primary | Ease of use daily diary | Qualitative assessments from subject questionnaires that allow evaluation of the ease of use of the study product. | Days 1-7 | |
Primary | GI tolerance daily diary | Qualitative assessments from subject questionnaires that allow evaluation of the gastro-intestinal tolerance of the study product. | Days 1-7 | |
Primary | Product compliance daily diary | Qualitative assessments from subject questionnaires that allow evaluation of compliance with the study product, i.e. actual versus prescribed intake. | Days 1-7 |
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