Acceptability Study on Nutricomp® Drink Plus Fibre in Adults | NCT03013803

Studies
Acceptability Study on Nutricomp® Drink Plus Fibre in Adults

NCT03013803

Sponsor

B. Braun Melsungen AG

Status

Completed

Last Update Posted

Aug 11, 2017Actual

Enrollment

19Actual

Phase

Not Applicable

Conditions

Adult Patients in Need of High-energy Oral Nutritional Supplementation

Interventions

Nutricomp Drink Plus Fibre

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Dec 19, 2016

First Submission Date that Met QC Criteria

Jan 5, 2017

First Posted Date

Jan 9, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2017

Last Update Posted Date

Aug 11, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 Fibre to show that it is acceptable for patients in the United Kingdom.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nutricomp Drink Plus Fibre	Experimental	Nutricomp® Drink Plus Fibre (flavours vanilla, coffee, peach-apricot and chocolate)	Dietary Supplement: Nutricomp Drink Plus Fibre

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nutricomp Drink Plus Fibre	Dietary Supplement		Nutricomp Drink Plus Fibre

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of gastrointestinal tolerance parameters		Day 1 - day 13

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of (further) adverse events during the treatment period (yes/no, if yes timing/duration/assumed cause/seriousness/severity)		Day 1 - day 13
Palatability evaluation performed under controlled condition using a questionnaire with a 5 point hedonic scale rang

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
AC Health & Nutrition Ltd		Leigh-on-Sea		SS9 3AA	United Kingdom

Intervention Browse Module

MeSH Terms

ID	Term
D004043	Dietary Fiber

Ancestor Terms

ID	Term
D004040	Dietary Carbohydrates
D002241	Carbohydrates
D005502	Food
D000066888	Diet, Food, and Nutrition

Browse Leaves

Not provided

Browse Branches

Not provided