Prospective Tolerance and Compliance Study With a High Caloric, High Protein Oral Nutritional Supplement in Nursing Home Residents - Scheduled Intake
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Malnutrition
- Sponsor
- Fresenius Kabi
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Gastro-intestinal (GI) tolerance assessed by subject (presence of GI symptoms assessed by subject's questionnaire)
- Status
- Completed
- Last Updated
- 9 years ago
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
Investigators
Eligibility Criteria
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)
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)