Clinical trial NCT01079260: An Investigation of the Efficacy of Oral Nutritional Supplements in Participants at Risk of Malnutrition
Official title: An Investigation of the Efficacy of High Energy, Low Volume Oral Nutritional Supplements in Participants at Risk of Malnutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Malnourished
Elderly
Nutrition support
Lead sponsor: Nutricia UK Ltd
Sponsor class: INDUSTRY
First posted: 2010-03-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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:

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).

Eligibility criteria: 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:

* Requirement for tube or parenteral nutrition
* Participants receiving palliative care
* Participants with chronic renal disease requiring dialysis
* Participants with liver failure
* Participants that are pregnant or lactating
* Participation in other studies

Primary outcomes:
measure: Nutrient intake (energy, protein and micronutrients)
timeFrame: 1week
Secondary outcomes:
measure: Compliance with ONS
timeFrame: 1week
measure: ONS Acceptability (taste, aroma) and ONS Preference (which type is preferred)
timeFrame: 1week
measure: Appetite
timeFrame: 1week
measure: Anthropometry
timeFrame: 6weeks
measure: Muscle Strength (Hand Grip Strength)
timeFrame: 6weeks
measure: Gastro-intestinal (GI) tolerance
timeFrame: 6weeks
Other outcomes:
Locations:
city: Swindon
country: United Kingdom
facility: Dietetics Dept, Great Western Hospital
state: Wiltshire
Study officials:
affiliation: Nutricia UK Ltd
name: Rebecca Stratton
role: PRINCIPAL_INVESTIGATOR
References: