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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
SocraTec R&D GmbH, Clinical Pharmacology Unit
Erfurt, Thuringia, Germany
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
Time frame: 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
Time frame: 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
Time frame: At study days 1-8
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
Time frame: At study day 1 and at study day 7
Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in mL)
Time frame: At study days 1-7
Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in %)
Time frame: At study days 1-7
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Compliance assessed by percentage of subjects who reached ≥ 75% of prescribed dose of ONS
Time frame: At study days 1-7
Use of ONS assessed by consumption time
Time frame: At study days 1-7
Use of ONS assessed by servings
Confirmation of intake
Time frame: At study days 1-7
Use of ONS assessed by presentation
Confirmation of serving temperature
Time frame: At study days 1-7
Reasons for non-compliance and non-use of ONS on a specific day or for early termination (provided by subject by open question)
Time frame: At study days 1-7