Acceptability Study on Nutricomp® Drink Plus Fibre in Adults (Fuchsia)

B. Braun

Status

Completed

Conditions

Adult Patients in Need of High-energy Oral Nutritional Supplementation

Treatments

Dietary Supplement: Nutricomp Drink Plus Fibre

Study type

Interventional

Funder types

Industry

Identifiers

NCT03013803

HC-G-H-1610

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

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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