Epilepsy, Fatty Acid Oxidation Disorder, Ketogenic Diet, Ketosis, Malabsorption
Conditions
Brief summary
This is a market research, observational study to evaluate the tolerability and acceptability of MCT supplements for young children and young people with intractable epilepsy, GLUT-1 or PDHD from 3 years to adulthood. Patients with a confirmed diagnosis of a fatty acid oxidation disorder, which requires a specialist diet including MCT will be included in this study
Interventions
DIETARY_SUPPLEMENTMCT fats
Subjects will be asked to take 3 new MCT products for 7 days each over a 25 day period (21 days taking the new products with 2 days between each new product trialled).
Sponsors
Dr. Schär AG / SPA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of epilepsy or a fatty acid oxidation disorder requiring a ketogenic or a specialist diet as part of their treatment, which includes MCT. * Subjects who are new to or already taking an MCT oil and are willing to try each of the 3 study products for 7 days each. 21 days taking product with 2 days between new product trialled. * Patients aged 3 years of age to adulthood. * Written informed consent obtained from patient or parental caregiver.
Exclusion criteria
* Presence of serious concurrent illness * Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements * Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study. * Any patients having taken antibiotics over the previous 2 weeks leading up to the study. * Patients less than 3 years of age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal tolerance | 7 days for each product, maximum 25 days | Questionnaire detailing any GI symptoms, severity and change from usual The collection of daily data about the gastrointestinal tolerance of the product |
| Product compliance | 7 days for each product, maximum 25 days | Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount. |
| Product palatability | 7 days for each product, maximum 25 days | Questionnaire data captured to evaluate taste |
| Product acceptability | 7 days for each product, maximum 25 days | Brief tick-box questionnaire on overall liking and acceptability of product |
Countries
United Kingdom
Outcome results
None listed