Adult ONS trial
Research type
Research Study
Full title
Evaluation of three new ready to drink oral nutritional supplements for the management of disease-related malnutrition in adults
IRAS ID
299055
Contact name
Corbin Griffen
Contact email
Sponsor organisation
Nutricia UK Ltd
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Central portfolio management system, 49287
Duration of Study in the UK
3 years, 4 months, 30 days
Research summary
Disease-related malnutrition (DRM) is a highly prevalent condition which leads to significant adverse health and economic burden. For the management of patients with DRM, oral nutritional supplements (ONS) are recommended and often prescribed (typically 1-3/day). ONS are energy- and nutrient-dense feeds that provide macro and micro-nutrients, designed to increase nutritional intake when diet alone is insufficient to meet daily nutritional requirements. The use of ONS has been shown to be effective for managing DRM by improving patient outcomes, including alleviating disease symptoms, aiding recovery from illness, regaining strength and improving quality of life, and reducing mortality. Additionally, the use of ONS has been reported to be cost effective in the healthcare setting due to reduced complications, fewer hospitalisations, and a reduced length of hospital stay.
An important outcome to enable ONS to be clinically and physiologically effective is compliance (i.e., how much the patient consumes relative to what is prescribed). Whilst good compliance to ONS in both hospital and community patients has been reported (78%), compliance in some patient groups has been reported to be as low as 35%. Poor compliance has been reported due to inability to consume the required volume, poor palatability, and taste fatigue. Furthermore, with increasing trends in plant-based food consumption and veganism, the lack of plant-based ONS may reduce compliance in vegan patients or those wishing to reduce animal-derived consumption for cultural or religious reasons. Consequently, there is a clear need for the development of different types of ONS which better cater both for patients with reported low compliance, but also patients with potentially higher compliance when presented with increased variety and choice.
The aim of this study is to evaluate compliance, acceptability, gastrointestinal tolerance, nutrient intake, appetite, nutritional status, and safety of three new ready to drink ONS: 1) an energy dense (3.2kcal/ml) low-volume (125ml) ONS; 2) a juice-style ONS with increased protein content (12 g/200ml); and 3) a plant-based ONS. This is a prospective, 3-independent arm, longitudinal, 28-day intervention study with a 1-day baseline period. During the intervention period, patients will receive one of the three ONS for 28 days alongside their routine diet. The study is being 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.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
21/NW/0203
Date of REC Opinion
27 Jul 2021
REC opinion
Further Information Favourable Opinion