Malnutrition
Conditions
Keywords
Malnutrition, Geriatric subjects, Nursing home
Brief summary
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
Interventions
DIETARY_SUPPLEMENTHigh caloric, high protein ONS
Sponsors
Fresenius Kabi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Sex: male/female 2. Age: 65 years or older 3. Body-mass index (BMI): ≥ 16.0 kg/m² and ≤ 30.0 kg/m² 4. Subjects with an indication for ONS of approx. 400 kcal per day for at least 7 days 5. Written informed consent
Exclusion criteria
1. Existing gastrointestinal diseases or pathological findings, which do not allow enteral nutrition 2. Subjects with galactosaemia or similar metabolic disorders 3. Subjects with severely impaired gastrointestinal function or complete failure 4. Subjects with insulin-requiring diabetes 5. Subjects with acute diarrhoea (defined as ≥ 3 loose or watery stools per day) 6. Subjects reporting frequent occurrence of migraine attacks 7. Subjects with acute or (current) chronic diseases, which might lead to impaired gustatory sense (e.g. sinusitis, anosmia) 8. Existing mouth abnormalities, which cause impaired gustatory sense 9. Subjects who report impaired gustatory sense (e.g. due to intake of concomitant medication) 10. Subjects passing through chemotherapy (last cycle \< 2 months ago) 11. Known allergic reactions or intolerance to any ingredient used or to constituents of the ONS 12. Subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical study by the investigator 13. Consumption of any additional ONS, enteral nutrition via tube or parenteral nutrition 14. Subjects with need of a special diet contradicting the intake of the ONS 15. History of relevant central nervous system (CNS) and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders 16. Subjects with dysphagia or with high aspiration risk 17. Enrolment in another clinical study 18. Administration of any investigational medicinal product during the last month prior to individual enrolment of the subject 19. Subjects who are not able to self-report GI-problems and compliance 20. Subjects who report a general dislike of the ONS flavour 21. Subjects for whom a hospitalisation for rehabilitation or surgery during the study is planned 22. Subjects suspected or known not to follow instructions 23. Subjects unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastro-intestinal (GI) tolerance assessed by subject (presence of GI symptoms assessed by subject's questionnaire) | At study days 1-8 | The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain |
| Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms) | At screening examination (study days -3 to -1) | The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in mL) | 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 presentation | At study days 1-7 | Confirmation of serving temperature |
| 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 | — |
| Use of ONS assessed by consumption | At study days 1-7 | Confirmation of consumption under supervision of study team |
| Palatability of ONS (assessed by subject's questionnaire by using a 5-point hedonic-scale) | At study days 1 and 7 | Assessment of palatability (using a 5-point hedonic-scale) regarding appearance, smell, taste, sweetness, mouthfeel and product in general |
Other
| Measure | Time frame |
|---|---|
| Adverse Events | At study days 1-8 |
Countries
Germany
Outcome results
None listed