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Acceptability Study on Oral Nutrition Supplement (ONS)

Acceptability Study on Nutricomp Drink Plus in Adult Patients

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02538250
Enrollment
23
Registered
2015-09-02
Start date
2015-07-31
Completion date
2015-10-31
Last updated
2016-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Nutritional Supplementation

Keywords

Oral nutritional supplement, supplementation, adult patients

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

Interventions

DIETARY_SUPPLEMENTNutricomp Drink Plus

Oral nutritional supplementation

Sponsors

B. Braun Medical UK Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of gastrointestinal tolerance parameters (Diarrhoea, Constipation, Bloating, Distension, Nausea, Vomiting, Burping, Regurgitation, Flatulence, Abdominal discomfort, Abdominal pain, Other (further gastrointestinal adverse events)7 daysParameters asked as required for acceptability studies by Advisory Committee for Borderline Substances- documented in a patient diary

Secondary

MeasureTime frameDescription
Occurrence of further adverse effects7 days
Evaluation of palatability by questionnaire1 dayFive point hedonic scale
Evaluation of compliance.7 daysComparison of prescription and actual intake

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026