Clinical trial NCT02938234: Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake
Official title: Prospective Tolerance and Compliance Study With a High Caloric, High Protein Oral Nutritional Supplement in Nursing Home Residents - ad Libitum Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Malnutrition
Geriatric subjects
Nursing home
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2016-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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

Primary outcomes:
measure: Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms)
timeFrame: At screening examination (study days -3 to -1)
measure: Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms)
timeFrame: At end of study (study day 8)
measure: Gastro-intestinal (GI) tolerance assessed by subject (presence of GI symptoms assessed by subject's questionnaire)
timeFrame: At study days 1-8
Secondary outcomes:
measure: Palatability of ONS (assessed by subject's questionnaire by using a 5-point hedonic-scale)
timeFrame: At study day 1 and at study day 7
measure: Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in mL)
timeFrame: At study days 1-7
measure: Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in %)
timeFrame: At study days 1-7
measure: Compliance assessed by percentage of subjects who reached ≥ 75% of prescribed dose of ONS
timeFrame: At study days 1-7
measure: Use of ONS assessed by consumption time
timeFrame: At study days 1-7
measure: Use of ONS assessed by servings
timeFrame: At study days 1-7
measure: Use of ONS assessed by presentation
timeFrame: At study days 1-7
measure: Reasons for non-compliance and non-use of ONS on a specific day or for early termination (provided by subject by open question)
timeFrame: At study days 1-7
Other outcomes:
measure: Adverse Events
timeFrame: At study days 1-8
Locations:
city: Erfurt
country: Germany
facility: SocraTec R&D GmbH, Clinical Pharmacology Unit
state: Thuringia
Study officials:
affiliation: SocraTec R&D GmbH, Clinical Pharmacology Unit
name: Cornelius Koch, MD
role: PRINCIPAL_INVESTIGATOR
References: