Market Research - Acceptability Study for a Range of MCT Products

Study Overview
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Brief Summary
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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

Official Title
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Market Research - Acceptability Study for a Range of New MCT Based Products (Dr Schär - Kanso MCT) Kanso MCT 100% Oil Kanso MCT 77% Oil Kanso MCT 83% Margarine

Conditions
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Ketosis, Epilepsy, Ketogenic Diet, Fatty Acid Oxidation Disorder, Malabsorption

Intervention / Treatment
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* Dietary Supplement: MCT fats


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MCT fats<br>Kanso MCT oils and margarine will be consumed daily for 7 days each to assess tolerability and compliance | Dietary Supplement: MCT fats<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal tolerance | Questionnaire detailing any GI symptoms, severity and change from usual The collection of daily data about the gastrointestinal tolerance of the product | 7 days for each product, maximum 25 days | 
| Product compliance | Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount. | 7 days for each product, maximum 25 days | 
| Product palatability | Questionnaire data captured to evaluate taste | 7 days for each product, maximum 25 days | 
| Product acceptability | Brief tick-box questionnaire on overall liking and acceptability of product | 7 days for each product, maximum 25 days |