Acceptability Study on Oral Nutrition Supplement (ONS)

October 12, 2016 updated by: B. Braun Medical UK Ltd.

Acceptability Study on Nutricomp Drink Plus in Adult Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Sheffield, United Kingdom, S10 2JF
        • Sheffield Teaching Hospitals NHS Foundation Trust, The Royal Hallamshire Hospital, Regional Gastrointestinal and Liver Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 Nutricomp Drink Plus
Nutricomp Drink Plus
Dietary supplement: Nutricomp Drink Plus
Oral nutritional supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of further adverse effects
Time Frame: 7 days
7 days
Evaluation of palatability by questionnaire
Time Frame: 1 day
Five point hedonic scale
1 day
Evaluation of compliance.
Time Frame: 7 days
Comparison of prescription and actual intake
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B. Braun Medical UK Ltd.

Investigators

  • Principal Investigator: David Sanders, Prof., The Royal Hallamshire Hospital,Regional Gastrointestinal and Liver Unit, Sheffield, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

September 1, 2015

First Posted (Estimate)

September 2, 2015

Study Record Updates

Last Update Posted (Estimate)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HC-G-H-1422

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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