Protein Top-up Study
Research type
Research Study
Full title
Acceptability of a ready to use, low calorie, low volume, high protein liquid for patients with increased protein needs
IRAS ID
285300
Contact name
Rebecca Stratton
Contact email
Sponsor organisation
Nutricia
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CPMS ID, 46437
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
A need for increased protein is frequently observed in disease. If not managed appropriately this may lead to reduced nutritional intake and increased risk of malnutrition. Medical nutrition support provided via enteral tube feeds or oral nutrition supplements is therefore necessary to help meet elevated protein needs. In some instances, achieving elevated protein needs can sometimes be difficult with enteral tube feeds or oral nutrition supplements alone. This is especially common in patients with normal to low energy requirements but with high protein needs, those unable to tolerate large volumes of enteral tube feeds and/or oral nutrition supplements, those with very high protein losses, with high energy requirements and exceptionally high protein needs. A low calorie, low volume, ready to use, high protein liquid modular (HPLM) feed may be beneficial for these patients to better meet protein needs but prevent caloric overfeeding.
Existing low volume, low calorie, high protein modular feeds however currently necessitate the need for decanting and/or diluting prior to use and feeding. This may increase contamination risk, instances of incorrect preparations (if dilutions are required) and inadequate provision of volume (if difficult to withdraw/decant from packaging and product spills). Consequently, a ready to use, low calorie, low volume HPLM feed has been developed in a sealed cup which may offer compositional, clinical and functional advantages.
The study is conducted for Advisory Committee on Borderline Substances (ACBS) and General Medical Services Scheme (GMS) reimbursement in the UK and Ireland, respectively, and is designed to meet their requirements for acceptability studies. As such, the aim of this study is to evaluate the acceptability (compliance, gastrointestinal tolerance and palatability) of a new HPLM feed, while also capturing information related to user experience (usability), dietary intake, risk of malnutrition, physical function, anthropometry and safety in forty eligible patients. Patients will firstly observe a 1-day baseline period, where patients continue with their existing care before receiving the new HPLM feed daily for 28 days alongside any additional routine nutritional management as required.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
20/SC/0350
Date of REC Opinion
22 Oct 2020
REC opinion
Further Information Favourable Opinion