Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake

Fresenius Kabi

Status: Completed

Conditions: Malnutrition

Treatments: Dietary Supplement: High caloric, high protein ONS

Study type: Interventional

Funder types: Industry

Identifiers

NCT02938234

F3kc-001-CNI

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Single-arm study

Experimental group

Description:

High caloric, high protein ONS, single dose of 400 kcal/day for 7 consecutive days, oral administration

Treatment:

Dietary Supplement: High caloric, high protein ONS