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

Study Overview
=================
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

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

Conditions
-----------------
Malnutrition

Intervention / Treatment
-----------------
* Dietary Supplement: High caloric, high protein ONS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sex: male/female Age: 65 years or older Body-mass index (BMI): ≥ 16.0 kg/m² and ≤ 30.0 kg/m² Subjects with an indication for ONS of approx. 400 kcal per day for at least 7 days Written informed consent Exclusion Criteria: Existing gastrointestinal diseases or pathological findings, which do not allow enteral nutrition Subjects with galactosaemia or similar metabolic disorders Subjects with severely impaired gastrointestinal function or complete failure Subjects with insulin-requiring diabetes Subjects with acute diarrhoea (defined as ≥ 3 loose or watery stools per day) Subjects reporting frequent occurrence of migraine attacks Subjects with acute or (current) chronic diseases, which might lead to impaired gustatory sense (e.g. sinusitis, anosmia) Existing mouth abnormalities, which cause impaired gustatory sense Subjects who report impaired gustatory sense (e.g. due to intake of concomitant medication) Subjects passing through chemotherapy (last cycle < 2 months ago) Known allergic reactions or intolerance to any ingredient used or to constituents of the ONS Subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical study by the investigator Consumption of any additional ONS, enteral nutrition via tube or parenteral nutrition Subjects with need of a special diet contradicting the intake of the ONS History of relevant central nervous system (CNS) and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders Subjects with dysphagia or with high aspiration risk Enrolment in another clinical study Administration of any investigational medicinal product during the last month prior to individual enrolment of the subject Subjects who are not able to self-report GI-problems and compliance Subjects who report a general dislike of the ONS flavour Subjects for whom a hospitalisation for rehabilitation or surgery during the study is planned Subjects suspected or known not to follow instructions 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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-arm study<br>High caloric, high protein ONS, single dose of 400 kcal/day for 7 consecutive days, oral administration | Dietary Supplement: High caloric, high protein ONS<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in mL) |  | At study days 1-7 | 
| Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in %) |  | At study days 1-7 | 
| Compliance assessed by percentage of subjects who reached ≥ 75% of prescribed dose of ONS |  | At study days 1-7 | 
| Use of ONS assessed by consumption time |  | At study days 1-7 | 
| Use of ONS assessed by servings | Confirmation of intake | At study days 1-7 | 
| Use of ONS assessed by presentation | Confirmation of serving temperature | At study days 1-7 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malnutrition, Geriatric subjects, Nursing home