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Completed

NCT Number: NCT02938234

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

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

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SocraTec R&D GmbH, Clinical Pharmacology Unit

Erfurt, Thuringia, 99084, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High caloric, high protein ONS

Dietary Supplement

Primary outcomes

  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 outcomes

  1. Palatability of ONS (assessed by subject's questionnaire by using a 5-point hedonic-scale)

    Time frame: At study day 1 and at study day 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

    Time frame: At study days 1-7

  6. Use of ONS assessed by servings

    Time frame: At study days 1-7

    Confirmation of intake

  7. Use of ONS assessed by presentation

    Time frame: At study days 1-7

    Confirmation of serving temperature

  8. 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 outcomes

  1. Adverse Events

    Time frame: At study days 1-8

Sponsors and collaborators

Lead sponsor

Fresenius Kabi

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 19, 2016
Registry last updated
Oct 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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