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

Malnutrition Clinical Trial

Official title:

Prospective Tolerance and Compliance Study With a High Caloric, High Protein Oral Nutritional Supplement in Nursing Home Residents - ad Libitum Intake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938234
• Other study ID #: F3kc-001-CNI
• Status: Completed
• Phase: N/A
• First received: September 12, 2016
• Last updated: October 17, 2016
• Start date: September 2016
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Fresenius Kabi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• High caloric, high protein ONS

Locations

Country	Name	City	State
Germany	SocraTec R&D GmbH, Clinical Pharmacology Unit	Erfurt	Thuringia

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Kabi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events		At study days 1-8	Yes
Primary	Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms)	The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain	At screening examination (study days -3 to -1)	No
Primary	Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms)	The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain	At end of study (study day 8)	No
Primary	Gastro-intestinal (GI) tolerance assessed by subject (presence of GI symptoms assessed by subject's questionnaire)	The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain	At study days 1-8	No
Secondary	Palatability of ONS (assessed by subject's questionnaire by using a 5-point hedonic-scale)	Assessment of palatability (using a 5-point hedonic-scale) regarding appearance, smell, taste, sweetness, mouthfeel and product in general	At study day 1 and at study day 7	No
Secondary	Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in mL)		At study days 1-7	No
Secondary	Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in %)		At study days 1-7	No
Secondary	Compliance assessed by percentage of subjects who reached = 75% of prescribed dose of ONS		At study days 1-7	No
Secondary	Use of ONS assessed by consumption time		At study days 1-7	No
Secondary	Use of ONS assessed by servings	Confirmation of intake	At study days 1-7	No
Secondary	Use of ONS assessed by presentation	Confirmation of serving temperature	At study days 1-7	No
Secondary	Reasons for non-compliance and non-use of ONS on a specific day or for early termination (provided by subject by open question)		At study days 1-7	No