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

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ClinicalTrials.gov Identifier: NCT02938247
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : October 20, 2016
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Malnutrition Dietary Supplement: High caloric, high protein ONS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prospective Tolerance and Compliance Study With a High Caloric, High Protein Oral Nutritional Supplement in Nursing Home Residents - Scheduled Intake
Study Start Date : September 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single-arm study
High caloric, high protein ONS, three portions daily, total dose of 400 kcal/day for 7 consecutive days, oral administration
Dietary Supplement: High caloric, high protein ONS



Primary Outcome Measures :
  1. Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms) [ Time Frame: At screening examination (study days -3 to -1) ]
    The presence of the following GI symptoms will be documented: diarrhoea, constipation, bloating, distension, nausea, vomiting, burping, regurgitation, flatulence, abdominal discomfort, abdominal pain

  2. Gastro-intestinal (GI) tolerance assessed by investigator (physical examination / presence of GI symptoms) [ Time Frame: 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

  3. Gastro-intestinal (GI) tolerance assessed by subject (presence of GI symptoms assessed by subject's questionnaire) [ Time Frame: 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


Secondary Outcome Measures :
  1. Palatability of ONS (assessed by subject's questionnaire by using a 5-point hedonic-scale) [ Time Frame: 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

  2. Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in mL) [ Time Frame: At study days 1-7 ]
  3. Compliance assessed by comparison of ONS amount prescribed vs. actual intake (in %) [ Time Frame: At study days 1-7 ]
  4. Compliance assessed by percentage of subjects who reached ≥ 75% of prescribed dose of ONS [ Time Frame: At study days 1-7 ]
  5. Use of ONS assessed by consumption [ Time Frame: At study days 1-7 ]
    Confirmation of consumption under supervision of study team

  6. Use of ONS assessed by presentation [ Time Frame: At study days 1-7 ]
    Confirmation of serving temperature

  7. 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) [ Time Frame: At study days 1-7 ]
  8. 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) [ Time Frame: At study days 1-7 ]

Other Outcome Measures:
  1. Adverse Events [ Time Frame: At study days 1-8 ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938247


Locations
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Germany
SocraTec R&D GmbH, Clinical Pharmacology Unit
Erfurt, Thuringia, Germany, 99084
Sponsors and Collaborators
Fresenius Kabi
Investigators
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Principal Investigator: Cornelius Koch, MD SocraTec R&D GmbH, Clinical Pharmacology Unit

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Responsible Party: Fresenius Kabi
ClinicalTrials.gov Identifier: NCT02938247     History of Changes
Other Study ID Numbers: F3kc-002-CNI
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: October 20, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Fresenius Kabi:
Malnutrition
Geriatric subjects
Nursing home

Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders