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

Not Applicable

Completed

• Conditions: Malnutrition
• Interventions: Dietary Supplement: High caloric, high protein ONS

• Registration Number: NCT02938247
• Lead Sponsor: Fresenius Kabi

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-12
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-19
• Last Update Submitted: 2016-10-19
• Last Update Posted: 2016-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-arm study	High caloric, high protein ONS	High caloric, high protein ONS, three portions daily, total dose of 400 kcal/day for 7 consecutive days, oral administration

Primary Outcome Measures

Name	Time	Method
Gastro-intestinal (GI) tolerance assessed by subject (presence of GI symptoms assessed by subject's questionnaire)	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)	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 Outcome Measures

Name	Time	Method
Palatability of ONS (assessed by subject's questionnaire by using a 5-point hedonic-scale)	At study days 1 and 7	Assessment of palatability (using a 5-point hedonic-scale) regarding appearance, smell, taste, sweetness, mouthfeel and product in general
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	Confirmation of consumption under supervision of study team
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	Confirmation of serving temperature
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

Trial Locations

Locations (1)

SocraTec R&D GmbH, Clinical Pharmacology Unit; 🇩🇪 Erfurt, Thuringia, Germany