Market Research - Acceptability Study for New MCT Fat 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, young people and adults with intractable epilepsy, GLUT-1 or PDHD from 3 years to adulthood.

Official Title
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Market Research - Acceptability Study for a Range of New MCT Based Products (Dr Schär - Kanso) Kanso DeliMCT 53% (Cream) Kanso DeliMCT 28% (Tomato or Mushroom) Kanso DeliMCT 21% (Cacaobar)

Conditions
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Ketosis, Epilepsy, Fatty Acid Oxidation Disorder, Malabsorption, Ketogenic Diet, Medium Chain Triglycerides

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 requiring a ketogenic or a specialist diet as part of their treatment. Subjects new to taking or who are already taking an MCT product and are willing to try each of the 3 study products for 7 days each. 21 days taking product with 2 days between each new product trialled. Those patients who have been taking MCT in their diet should do so for a minimum of 4 weeks before commencement of the study. 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 already on and MCT product who have been taking it in their diet for less than 4 weeks Patients less than 3 years of age Patients over 20 years.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 20 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MCT fats<br>MCT fats to be consumed, one portion per day to ensure tolerance and compliance to the product whilst support the dietary management for a range if disease states namely, the ketogenic diet, fatty acid oxidation disorders and malabsorption. | Dietary Supplement: MCT fats<br>* Subjects will be asked to take 3 new MCT products for 7 days each over a 25 day period<br>* Other names: medium chain triglycerides;|

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 |