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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCT fats | Experimental | Kanso MCT oils and margarine will be consumed daily for 7 days each to assess tolerability and compliance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCT fats | Dietary Supplement | 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). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bristol Royal Hospital for Children | Bristol | BS2 8BJ | United Kingdom | |||
| Royal Manchester Children's Hospital |
This study will be used to demonstrate acceptability for registration and reimbursement of these foods for special medical purposes.
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| ID | Term |
|---|---|
| D007662 | Ketosis |
| D004827 | Epilepsy |
| D008286 | Malabsorption Syndromes |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Manchester |
| M13 9WL |
| United Kingdom |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |