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

NCT ID: NCT02938247

Last Updated: 2016-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2016-10-31

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

Conditions

Malnutrition

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Single-arm study

High caloric, high protein ONS, three portions daily, total dose of 400 kcal/day for 7 consecutive days, oral administration

Group Type: EXPERIMENTAL

High caloric, high protein ONS

Intervention Type: DIETARY_SUPPLEMENT

Interventions

High caloric, high protein ONS

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Kabi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cornelius Koch, MD

Role: PRINCIPAL_INVESTIGATOR

SocraTec R&D GmbH, Clinical Pharmacology Unit

Locations

SocraTec R&D GmbH, Clinical Pharmacology Unit

Erfurt, Thuringia, Germany

Countries

Germany

Other Identifiers

F3kc-002-CNI

Identifier Type: -

Identifier Source: org_study_id