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This is a multi-center, prospective, non-randomized, non-blinded, single-arm, single treatment study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Nutrition Product | Experimental | 2 servings per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Nutrition Product | Other | High energy, high protein oral nutritional supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Tolerance | Bristol Stool Form Scale; Stool is classified into 7 groups (Types 1-7) with Type 3-4 as ideal stools | Study Day 1 - Study Day 7 |
| 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 - Study Day 7 |
| Nutritional Supplement Compliance |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Subject reported adverse events | Baseline - Study Day 8 |
| Anthropometric | BMI calculated from Height in m and Weight in kg | Baseline and Study Day 8 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Camprubi, PhD | Abbott | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Coast Medical | Newquay | Cornwall | TR7 1RU | United Kingdom | ||
| Atlantic Medical Group |
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Subject completed daily intake questionnaire including amount of serving consumed
| Study Day 1 - Study Day 7 |
| Penzance |
| Cornwall |
| TR18 3DX |
| United Kingdom |
| Hull University Teaching Hospital | Anlaby | Hull | HU3 2PA | United Kingdom |