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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCT fats | Experimental | 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. |
|
| 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 |
|
| 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 |
|---|---|---|---|---|---|---|
| Royal Aberdeen Children's Hospital | Aberdeen | Grampian | AB25 2ZG | United Kingdom |
This study will be used for the registration and reimbursement for the products used as 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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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |