NCT02938247CompletedNot Applicable
Prospective Tolerance and Compliance Study With a High Caloric, High Protein Oral Nutritional Supplement in Nursing Home Residents - Scheduled Intake
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fresenius Kabi
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Gastro-intestinal (GI) tolerance assessed by subject (presence of GI symptoms assessed by subject's questionnaire)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Sex: male/female
- •Age: 65 years or older
- •Body-mass index (BMI): ≥ 16.0 kg/m² and ≤ 30.0 kg/m²
- •Subjects with an indication for ONS of approx. 400 kcal per day for at least 7 days
- •Written informed consent
Exclusion Criteria
- •Existing gastrointestinal diseases or pathological findings, which do not allow enteral nutrition
- •Subjects with galactosaemia or similar metabolic disorders
- •Subjects with severely impaired gastrointestinal function or complete failure
- •Subjects with insulin-requiring diabetes
- •Subjects with acute diarrhoea (defined as ≥ 3 loose or watery stools per day)
- •Subjects reporting frequent occurrence of migraine attacks
- •Subjects with acute or (current) chronic diseases, which might lead to impaired gustatory sense (e.g. sinusitis, anosmia)
- •Existing mouth abnormalities, which cause impaired gustatory sense
- •Subjects who report impaired gustatory sense (e.g. due to intake of concomitant medication)
- •Subjects passing through chemotherapy (last cycle < 2 months ago)
- •Known allergic reactions or intolerance to any ingredient used or to constituents of the ONS
- •Subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical study by the investigator
- •Consumption of any additional ONS, enteral nutrition via tube or parenteral nutrition
- •Subjects with need of a special diet contradicting the intake of the ONS
- •History of relevant central nervous system (CNS) and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
- •Subjects with dysphagia or with high aspiration risk
- •Enrolment in another clinical study
- •Administration of any investigational medicinal product during the last month prior to individual enrolment of the subject
- •Subjects who are not able to self-report GI-problems and compliance
- •Subjects who report a general dislike of the ONS flavour
- •Subjects for whom a hospitalisation for rehabilitation or surgery during the study is planned
- •Subjects suspected or known not to follow instructions
- •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
Outcomes
Primary Outcomes
Gastro-intestinal (GI) tolerance assessed by subject (presence of GI symptoms assessed by subject's questionnaire)
Time Frame: 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)
Time Frame: At end of study (study day 8)
The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain
Secondary Outcomes
- Palatability of ONS (assessed by subject's questionnaire by using a 5-point hedonic-scale)(At study days 1 and 7)
- Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in %)(At study days 1-7)
- Use of ONS assessed by consumption(At study days 1-7)
- Compliance assessed by percentage of subjects who reached ≥ 75% of prescribed dose of ONS(At study days 1-7)
- Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in mL)(At study days 1-7)
- Use of ONS assessed by presentation(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)
Investigators
Study Sites (2)
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