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Completed

NCT Number: NCT02538250

Acceptability Study on Oral Nutrition Supplement (ONS)

Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus to show that it is acceptable for patients in the United Kingdom.

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Key information

Conditions

Oral Nutritional Supplementation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sheffield Teaching Hospitals NHS Foundation Trust, The Royal Hallamshire Hospital, Regional Gastrointestinal and Liver Unit

Sheffield, S10 2JF, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion:

  • Male and female patients
  • ≥ 18 years of age
  • Patients of the intended target group (e.g. MUST score ≥ 1) with an anticipated period of nutritional support ≥ 7 days
  • Patient is able and willing to provide written informed consent

Exclusion:

  • Hypersensitivity to milk, whey, soy, fish or any of the active substances or excipients
  • Patients with available or potential impairment of sense of taste or smell due to disease (e.g. patients with cold, cancer patients) or medication (e.g. D-Penicillamine)
  • Patients who express general dislike to two or more of the four flavours
  • Severely impaired gastrointestinal function or complete failure
  • Severe metabolic or circulatory disorders
  • Acute disease
  • Unstable vital functions
  • Necessity of total parenteral nutrition or more than 50% Parenteral Nutrition in combined therapy
  • Simultaneous participation in another interventional study
  • Patients who are unwilling or mentally and/or physically unable to adhere to study procedures
  • Pregnancy
  • Emergencies

Treatment and study plan

Nutricomp Drink Plus

Dietary Supplement

Oral nutritional supplementation

Primary outcomes

  1. Occurrence of gastrointestinal tolerance parameters (Diarrhoea, Constipation, Bloating, Distension, Nausea, Vomiting, Burping, Regurgitation, Flatulence, Abdominal discomfort, Abdominal pain, Other (further gastrointestinal adverse events)

    Time frame: 7 days

    Parameters asked as required for acceptability studies by Advisory Committee for Borderline Substances- documented in a patient diary

Secondary outcomes

  1. Occurrence of further adverse effects

    Time frame: 7 days

  2. Evaluation of palatability by questionnaire

    Time frame: 1 day

    Five point hedonic scale

  3. Evaluation of compliance.

    Time frame: 7 days

    Comparison of prescription and actual intake

Sponsors and collaborators

Lead sponsor

B. Braun Medical UK Ltd.

Industry

Registry information

Official study title

Acceptability Study on Nutricomp Drink Plus in Adult Patients

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 2, 2015
Registry last updated
Oct 13, 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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