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| ID | Type | Description | Link |
|---|---|---|---|
| 196542 | Other Identifier | IRAS |
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To evaluate the tolerance, acceptability and compliance of Keyo in 20 subjects aged 3 years and over, with intractable epilepsy or Glut-1 DS on a KD.
Qualitative assessments from subject questionnaires that allow evaluation of the acceptability and ease of use of the study product.
Collection of daily data about the gastro-intestinal tolerance of the study product.
Collection of daily data about compliance with the study product i.e. actual versus prescribed intake.
Improve quality of life by increasing range of foods available for use in a ketogenic diet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Consumption of Keyo | Experimental | Participants will consume their normal KD and take Keyo as advised by the lead dietitian. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Keyo | Dietary Supplement | Keyo is a Food for Special Medical Purposes (FSMP) and is intended for use in the KD. It has a fat to protein and carbohydrate ratio of 3 to 1. This makes it appropriate for inclusion in all versions of the KD - classical, MCT, MAD and LGI. Keyo has been designed as a nutritionally complete, ready to use, pleasant tasting and versatile medical food for use in a KD. |
| Measure | Description | Time Frame |
|---|---|---|
| Palatability questionnaire | Qualitative assessment from subject questionnaire that allows evaluation of the palatability of the study product. | Day 8 |
| Ease of use daily diary | Qualitative assessments from subject questionnaires that allow evaluation of the ease of use of the study product. | Days 1-7 |
| GI tolerance daily diary | Qualitative assessments from subject questionnaires that allow evaluation of the gastro-intestinal tolerance of the study product. | Days 1-7 |
| Product compliance daily diary | Qualitative assessments from subject questionnaires that allow evaluation of compliance with the study product, i.e. actual versus prescribed intake. | Days 1-7 |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Helen McCullagh, BSc, MBChB | Leeds Teaching Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Manchester University Hospitals NHS Foundation Trust | Manchester | Greater Manchester | M13 9WL | United Kingdom | ||
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| C536830 | Glut1 Deficiency Syndrome |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Leeds Teaching Hospitals NHS Trust |
| Leeds |
| West Yorkshire |
| LS1 3EX |
| United Kingdom |