Acceptability Study on Oral Nutrition Supplement (ONS)

Oral Nutritional Supplementation Clinical Trial

Official title:

Acceptability Study on Nutricomp Drink Plus in Adult Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02538250
• Other study ID #: HC-G-H-1422
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2015
• Last updated: October 12, 2016
• Start date: July 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2016
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Oral Nutritional Supplementation

Intervention

Dietary Supplement:
• Nutricomp Drink Plus
Oral nutritional supplementation

Locations

Country	Name	City	State
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust, The Royal Hallamshire Hospital, Regional Gastrointestinal and Liver Unit	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Medical UK Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of gastrointestinal tolerance parameters (Diarrhoea, Constipation, Bloating, Distension, Nausea, Vomiting, Burping, Regurgitation, Flatulence, Abdominal discomfort, Abdominal pain, Other (further gastrointestinal adverse events)	Parameters asked as required for acceptability studies by Advisory Committee for Borderline Substances- documented in a patient diary	7 days	No
Secondary	Occurrence of further adverse effects		7 days	Yes
Secondary	Evaluation of palatability by questionnaire	Five point hedonic scale	1 day	No
Secondary	Evaluation of compliance.	Comparison of prescription and actual intake	7 days	No