B. Braun Medical Ltd. - Fuchsia
Research type
Research Study
Full title
FUCHSIA; B. Braun Medical Ltd. Fuchsia - Tolerance and Acceptability Study
IRAS ID
216765
Contact name
Karen Jackson
Contact email
Sponsor organisation
B BRAUN Medical LTD
Duration of Study in the UK
0 years, 0 months, 14 days
Research summary
Oral nutritional support may be essential for people who are unable to meet their nutritional needs solely from food and fluids. This is particularly the case for those who are in nursing/residential care, requiring encouragement with meals or on a fortified diet.
Nutricomp Drink Plus Fibre, the investigational product (IP), is a ready to drink Oral Nutritional Supplement (ONS). The aim of this study is to test the acceptability of this product looking at volume taken, tolerance and participants’ views.
Ideally 20 residents of UK-based, non-NHS, nursing/residential homes who require additional oral nutritional support through ONS will be recruited to the study. They will be monitored daily whilst they continue with their current ONS for 3 days (baseline) and then will be changed to the trial product for 2 days (transitional) and 7 days (intervention). Including the two days for recruitment and completing paperwork, each participant will therefore be on the study for 14 days.
Between days 4-12, participants will receive the IP instead of their usual prescribed ONS at each prescription time. E.g. If a participant was previously on Fortisip Compact, twice a day at 08:00 and 17:00 their trial prescription would become the IP, twice a day, at 08:00 and 17:00. The ONS is always given by trained staff.
This study is being carried out by members of the AC Health and Nutrition team which include Dietitians. The trial is sponsored by B. BRAUN MEDICAL LTD.
REC name
East of England - Essex Research Ethics Committee
REC reference
16/EE/0462
Date of REC Opinion
11 Nov 2016
REC opinion
Favourable Opinion