Acceptability trial of a new Oral Nutritional Supplement
Research type
Research Study
Full title
Ten-day acceptability and tolerance trial of a new Oral Nutritional Supplement (ONS) in patients at risk of malnutrition
IRAS ID
263404
Contact name
S I Sunram-Lea
Contact email
Sponsor organisation
Lancaster University
Duration of Study in the UK
0 years, 3 months, 1 days
Research summary
Malnourishment is prevalent in the UK with a high number of people malnourished or at risk of malnourishment. People who are malnourished are predisposed to multiple diseases and health conditions. Moreover, those suffering from malnutrition may be admitted to hospital more often, stay in hospital for longer and visit their GP more frequently. Oral Nutritional Supplements (ONS) are commonly prescribed to malnourished patients or those at risk of malnourishment to improve their nutritional status. Increasing the patient’s nutrient intake potentially results in a number of positive health impacts which may then, in turn, reduce the risk of susceptibility to further illness. Although for some people ONS may be beneficial, their use can be limited by poor compliance due to low palatability or unwanted gastrointestinal side effects. The aim of this study is to investigate gastrointestinal tolerance, acceptability and compliance to a new complete powder formula nutritional supplement, Kendalife Medi+(Kendal Nutricare Ltd®), a product aimed at individuals (18-90 years old) who may be malnourished or at risk of malnourishment and requiring meal-replacement supplementation. The trial will take place at Blackpool hospital trust and the intervention will be administered to participants at risk of malnutrition (MUST score 1 or above) who are already receiving ONS intervention. Participants will be monitored for 10 days in total. For the first 2 days patients on the currently prescribed ONS for baseline measurements, and for the remaining 8 consecutive days, Kendalife Medi+ONS will be administered 2 times per day in hospital. Participants will continue to complete the daily questionnaires during this period. If the patient is discharged from hospital care prior to study completion, they will be provided with leaflets and information on how to prepare the drink to be taken at their home for the remaining period. Measures of weight and height will be taken, and data will be collected on gastrointestinal (GI) tolerance, compliance, palatability, and mood. Palatable ONS which result in fewer GI problems may result in improved adherence and better outcomes for patients. The outcome of this study will inform us about the potential benefits of a new cost effective ONS.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
20/NE/0083
Date of REC Opinion
21 Apr 2020
REC opinion
Further Information Favourable Opinion