Acceptability Study on Nutricomp® Drink Plus Fibre in Adults

Adult Patients in Need of High-energy Oral Nutritional Supplementation Clinical Trial

— Fuchsia  

Official title:

Acceptability Study on Nutricomp® Drink Plus Fibre in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03013803
• Other study ID #: HC-G-H-1610
• Status: Completed
• Phase: N/A
• First received: December 19, 2016
• Last updated: August 10, 2017
• Start date: December 2016
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Patients in Need of High-energy Oral Nutritional Supplementation

Intervention

Dietary Supplement:
• Nutricomp Drink Plus Fibre

Locations

Country	Name	City	State
United Kingdom	AC Health & Nutrition Ltd	Leigh On Sea

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of gastrointestinal tolerance parameters		Day 1 - day 13
Secondary	Occurrence of (further) adverse events during the treatment period (yes/no, if yes timing/duration/assumed cause/seriousness/severity)		Day 1 - day 13
Secondary	Palatability evaluation performed under controlled condition using a questionnaire with a 5 point hedonic scale rang		Day 1 - day 13