Acceptability Study on Nutricomp® Drink Plus Fibre in Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Adult Patients in Need of High-energy Oral Nutritional Supplementation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nutricomp Drink Plus Fibre

Nutricomp® Drink Plus Fibre (flavours vanilla, coffee, peach-apricot and chocolate)

Group Type EXPERIMENTAL

Nutricomp Drink Plus Fibre

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Nutricomp Drink Plus Fibre

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No