Acceptability Study on Oral Nutrition Supplement (ONS)

B. Braun

Status and phase: Completed; Phase 4

Conditions: Oral Nutritional Supplementation

Treatments: Dietary Supplement: Nutricomp Drink Plus

Study type: Interventional

Funder types: Industry

Identifiers

NCT02538250

HC-G-H-1422

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

23 participants in 1 patient group

1 Nutricomp Drink Plus

Experimental group

Description:

Nutricomp Drink Plus

Treatment:

Dietary Supplement: Nutricomp Drink Plus