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The aim of the study is to assess gastro-intestinal tolerance, palatability, compliance, and use of a high caloric, high protein oral nutritional supplement (ONS) in elderly people
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm study | Experimental | High caloric, high protein ONS, three portions daily, total dose of 400 kcal/day for 7 consecutive days, oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High caloric, high protein ONS | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms) | The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain | At screening examination (study days -3 to -1) |
| Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms) | The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain | At end of study (study day 8) |
| Gastro-intestinal (GI) tolerance assessed by subject (presence of GI symptoms assessed by subject's questionnaire) | The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain | At study days 1-8 |
| Measure | Description | Time Frame |
|---|---|---|
| Palatability of ONS (assessed by subject's questionnaire by using a 5-point hedonic-scale) | Assessment of palatability (using a 5-point hedonic-scale) regarding appearance, smell, taste, sweetness, mouthfeel and product in general | At study days 1 and 7 |
| Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in mL) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | At study days 1-8 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cornelius Koch, MD | SocraTec R&D GmbH, Clinical Pharmacology Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SocraTec R&D GmbH, Clinical Pharmacology Unit | Erfurt | Thuringia | 99084 | Germany |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| At study days 1-7 |
| Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in %) | At study days 1-7 |
| Compliance assessed by percentage of subjects who reached ≥ 75% of prescribed dose of ONS | At study days 1-7 |
| Use of ONS assessed by consumption | Confirmation of consumption under supervision of study team | At study days 1-7 |
| Use of ONS assessed by presentation | Confirmation of serving temperature | At study days 1-7 |
| Reasons for non-compliance of ONS at a specific time of the day or on a specific day or for early termination (provided by subject by open question) | At study days 1-7 |
| Reasons for non-use of ONS at a specific time of the day or on a specific day or for early termination (provided by subject by open question) | At study days 1-7 |