Undernutrition Clinical Trial
Official title:
An Investigation of the Effects of Different Modes of Delivery of Oral Nutritional Supplements in Participants at Risk of Malnutrition - A Pilot Study
Disease-related malnutrition is common across healthcare settings in the UK and if left
untreated, may have severe consequences. One of the strategies commonly used to combat
malnutrition is the use of oral nutritional supplements (ONS). However, there is uncertainty
about the optimal way of delivering ONS to patients to maximize compliance and nutrient
intake.
This randomised study will investigate the effect of different modes of delivery (ad libitum
versus instructions on timing/serving volume) of ONS used in addition to the diet on total
nutrient intake, compliance, nutritional status and outcome in participants at risk of
malnutrition.
Participants will be randomised to receive one of two ONS (high energy or standard) for 4
weeks in addition to food, either taken 'Ad libitum', or according to instruction on what to
take and when. The primary outcome measure is nutrient intake. Secondary outcome measures
include compliance and acceptability of ONS, appetite, anthropometry, muscle strength,
quality of life and gastro-intestinal tolerance.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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