An Investigation of the Efficacy of Oral Nutritional Supplements in Participants at Risk of Malnutrition
An Investigation of the Efficacy of High Energy, Low Volume Oral Nutritional Supplements in Participants at Risk of Malnutrition
This study aims to investigate the efficacy of high energy, low volume oral nutritional
supplements (ONS) compared to equivalent standard ONS (control) to maximize nutrient intake,
compliance, gastro intestinal tolerance and function, in participants at risk of
In current clinical practice malnourished (undernourished) patients may receive oral
nutritional supplements (ONS) to aid in the management of their malnutrition
(undernutrition). Poor compliance to ONS was been reported in the scientific literature,
however recent studies of a low volume, high energy ONS have shown high compliance. This
study aims to further explore compliance to low volume ONS compared to standard ONS. This
study is a 2 week cross over study with a 4 week optional extension. Participants at risk of
malnutrition will receive a low volume, high energy ONS for 1 week and a standard ONS for 1
week in a random order to compare nutrient intake and compliance. This short term element of
the study was designed based on a similar study by Hubbard et al 2009, where significant
differences in compliance and energy intake were observed. Participants may then take part
in an optional 4 week extension period where they will receive their preferred ONS for 4
weeks. Longer term outcomes such as change in weight, muscle function and tolerance to the
ONS will be measured in this part of the study. Changes in weight and muscle function are
typically seen in 4 weeks.
Overview of the study:
1. Participants will be assessed for inclusion and exclusion criteria by the investigating
dietitian or research nurse, and then provided with information about the study.
Eligible participants will be asked for their written informed consent. Participant
characteristics and medical history will be collected.
2. Participants will be randomly allocated to receive either:
A. A standard ONS (1.5kcal/ml) as control, ad libitum in addition to diet for 7 days.
Participants will then receive the high energy, low volume equivalent ONS (2.4kcal/ml) ad
libitum in addition to diet for 7 days (n=70), or:
B. A high energy, low volume ONS (2.4kcal/ml) ad libitum in addition to diet for 7 days.
Participants will then receive the equivalent standard ONS (1.5kcal/ml) as control, ad
libitum in addition to diet for 7 days (n=70). Participants will then have an option to
continue with their preferred ONS for a further 4 weeks (28 days).
Malnourished, Elderly, Nutrition support
Nutricia UK Ltd
Nutricia UK Ltd