An Investigation of the Efficacy of Oral Nutritional Supplements in Participants at Risk of Malnutrition

Nutricia

Status

Completed

Conditions

Malnutrition

Treatments

Dietary Supplement: High Energy, low volume ONS

Dietary Supplement: Standard ONS

Study type

Interventional

Funder types

Industry

Identifiers

NCT01079260

NCC300

Details and patient eligibility

About

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 malnutrition.

Full description

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:

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.
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).

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female
Age > 18 years
At risk of malnutrition (medium or high risk of malnutrition with 'Malnutrition Universal Screening Tool', 'MUST' score ≥ 1)
Competent to provide written informed consent and able to answer questions
No requirement for tube or parenteral feeding
Willingness to take part in the study and to follow the study protocol

Exclusion criteria