Acceptability Study on Oral Nutrition Supplement (ONS)

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

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-10-31

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 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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Oral Nutritional Supplementation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1 Nutricomp Drink Plus

Nutricomp Drink Plus

Group Type EXPERIMENTAL

Nutricomp Drink Plus

Intervention Type DIETARY_SUPPLEMENT

Oral nutritional supplementation

Interventions

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Nutricomp Drink Plus

Oral nutritional supplementation

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No