The Protein Partners Ltd - NV1
Research type
Research Study
Full title
NV1; The Protein Partners Ltd - Tolerance and Acceptability Study
IRAS ID
294980
Contact name
Stephen Simons
Contact email
Sponsor organisation
The Protein Partners Ltd
Duration of Study in the UK
0 years, 0 months, 15 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 study is designed to determine if a new nutritional supplement is tolerated and acceptable so it can be available in the community (at NHS expense).
Poor oral intake is commonplace in nursing homes/residential care and hospitals, these patients require encouragement with meals or on a fortified diet/prescribed supplements to boost nutritional intake.
NuVu Milkshake, the investigational product (IP), is a powdered 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 The Protein Powders Ltd
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
21/PR/0163
Date of REC Opinion
4 Jun 2021
REC opinion
Further Information Favourable Opinion