- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03013803
Acceptability Study on Nutricomp® Drink Plus Fibre in Adults (Fuchsia)
August 10, 2017 updated by: B. Braun Melsungen AG
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 Fibre to show that it is acceptable for patients in the United Kingdom.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
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
-
-
-
Leigh On Sea, United Kingdom, SS9 3AA
- AC Health & Nutrition Ltd
-
-
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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Male and female participants ≥ 18 years of age
- Assessed to have malnutrition or be at risk of malnutrition by a Dietician within the investigator team. Assessment to include, but not limited to weight loss history, current BMI/MUST score, anamnesis, dietary intake history and predicted future oral intake.
- Anticipated period of nutritional support ≥ 12 days
- Patient has the capacity and is willing to provide informed consent.
Exclusion criteria:
- Participants with mental in capabilities who are unable to give informed consent
- Hypersensitivity to any of the active substances or excipients within the IP
- Severely impaired gastrointestinal function or complete failure
- More than 50% of nutrition from Parenteral Nutrition
- Simultaneous participation in another interventional study
- Participants who are unwilling or mentally and/or physically unable to adhere to study procedures
- Participants with dysphagia requiring thickened fluids
- Participants with significant renal impairment (CKD)
- Pregnancy
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
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Nutricomp Drink Plus Fibre
Nutricomp® Drink Plus Fibre (flavours vanilla, coffee, peach-apricot and chocolate)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of gastrointestinal tolerance parameters
Time Frame: Day 1 - day 13
|
Day 1 - day 13
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of (further) adverse events during the treatment period (yes/no, if yes timing/duration/assumed cause/seriousness/severity)
Time Frame: Day 1 - day 13
|
Day 1 - day 13
|
Palatability evaluation performed under controlled condition using a questionnaire with a 5 point hedonic scale rang
Time Frame: Day 1 - day 13
|
Day 1 - day 13
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
December 1, 2016
Primary Completion (ACTUAL)
December 1, 2016
Study Completion (ACTUAL)
December 1, 2016
Study Registration Dates
First Submitted
December 19, 2016
First Submitted That Met QC Criteria
January 5, 2017
First Posted (ESTIMATE)
January 9, 2017
Study Record Updates
Last Update Posted (ACTUAL)
August 11, 2017
Last Update Submitted That Met QC Criteria
August 10, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- HC-G-H-1610
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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