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

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
High caloric, high protein ONS
Sponsored by
Fresenius Kabi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malnutrition focused on measuring Malnutrition, Geriatric subjects, Nursing home

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • SocraTec R&D GmbH, Clinical Pharmacology Unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single-arm study

Arm Description

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

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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
Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in mL)
Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in %)
Compliance assessed by percentage of subjects who reached ≥ 75% of prescribed dose of ONS
Use of ONS assessed by consumption time
Use of ONS assessed by servings
Confirmation of intake
Use of ONS assessed by presentation
Confirmation of serving temperature
Reasons for non-compliance and non-use of ONS on a specific day or for early termination (provided by subject by open question)

Full Information

First Posted
September 12, 2016
Last Updated
October 17, 2016
Sponsor
Fresenius Kabi
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1. Study Identification

Unique Protocol Identification Number
NCT02938234
Brief Title
Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake
Official Title
Prospective Tolerance and Compliance Study With a High Caloric, High Protein Oral Nutritional Supplement in Nursing Home Residents - ad Libitum Intake
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fresenius Kabi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Malnutrition, Geriatric subjects, Nursing home

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-arm study
Arm Type
Experimental
Arm Description
High caloric, high protein ONS, single dose of 400 kcal/day for 7 consecutive days, oral administration
Intervention Type
Dietary Supplement
Intervention Name(s)
High caloric, high protein ONS
Primary Outcome Measure Information:
Title
Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms)
Description
The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain
Time Frame
At screening examination (study days -3 to -1)
Title
Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms)
Description
The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain
Time Frame
At end of study (study day 8)
Title
Gastro-intestinal (GI) tolerance assessed by subject (presence of GI symptoms assessed by subject's questionnaire)
Description
The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain
Time Frame
At study days 1-8
Secondary Outcome Measure Information:
Title
Palatability of ONS (assessed by subject's questionnaire by using a 5-point hedonic-scale)
Description
Assessment of palatability (using a 5-point hedonic-scale) regarding appearance, smell, taste, sweetness, mouthfeel and product in general
Time Frame
At study day 1 and at study day 7
Title
Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in mL)
Time Frame
At study days 1-7
Title
Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in %)
Time Frame
At study days 1-7
Title
Compliance assessed by percentage of subjects who reached ≥ 75% of prescribed dose of ONS
Time Frame
At study days 1-7
Title
Use of ONS assessed by consumption time
Time Frame
At study days 1-7
Title
Use of ONS assessed by servings
Description
Confirmation of intake
Time Frame
At study days 1-7
Title
Use of ONS assessed by presentation
Description
Confirmation of serving temperature
Time Frame
At study days 1-7
Title
Reasons for non-compliance and non-use of ONS on a specific day or for early termination (provided by subject by open question)
Time Frame
At study days 1-7
Other Pre-specified Outcome Measures:
Title
Adverse Events
Time Frame
At study days 1-8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cornelius Koch, MD
Organizational Affiliation
SocraTec R&D GmbH, Clinical Pharmacology Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
SocraTec R&D GmbH, Clinical Pharmacology Unit
City
Erfurt
State/Province
Thuringia
ZIP/Postal Code
99084
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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

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