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This is a multi-center, prospective, non-randomized, non-blinded, single-arm, single treatment study to evaluate the tolerance of a nutritional pudding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Nutritional Pudding | Experimental | 2 servings per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Nutritional Pudding | Other | High Calorie, High Protein pudding |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastro-Intestinal Tolerance | Subject completed Bristol Stool Type questionnaire; Stool is classified into 7 groups (Types 1-7) with Type 3-4 as ideal stools | Study Day 1 to Study Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional Supplement Palatability | Subject completed questionnaire; 4 questions scaled from 1 -Dislike Extremely to 9-Like Extremely; 2 questions scaled from Not at all Enough to Far Too | Study Day 1 to Study Day 8 |
| Nutritional Supplement Compliance |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | For BMI Calculation | Baseline to Study Day 28 |
| Height | For BMI Calculation | Baseline to Study Day 28 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Camprubi, PhD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Coast Medical Ltd, Newquay Health Centre | Newquay | Cornwall | TR7 1RU | United Kingdom | ||
| The Alverton Practice, Atlantic Medical |
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Subject completed daily intake questionnaire including amount of serving consumed |
| Study Day 1 to Study Day 28 |
| Medication Usage | Subject reported medication usage | Baseline to Study Day 28 |
| Adverse Events | Subject reported adverse events | Baseline to Study Day 28 |
| Penzance |
| Cornwall |
| TR18 3DX |
| United Kingdom |
| Morrab Surgery | Penzance | Cornwall | TR18 4EL | United Kingdom |