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

Malnutrition Clinical Trial

Official title:

An Investigation of the Efficacy of High Energy, Low Volume Oral Nutritional Supplements in Participants at Risk of Malnutrition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079260
• Other study ID #: NCC300
• Status: Completed
• Phase: N/A
• First received: February 25, 2010
• Last updated: November 12, 2014
• Start date: February 2010
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• Source: Nutricia UK Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• Standard ONS
Standard ONS
• High Energy, low volume ONS
High energy, low volume ONS

Locations

Country	Name	City	State
United Kingdom	Dietetics Dept, Great Western Hospital	Swindon	Wiltshire

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia UK Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutrient intake (energy, protein and micronutrients)	Dietary intake, including the intake of all foods, drinks and ONS will be recorded at baseline (day 1), at the end of week 1, at the end of week 2 and at the end of the optional extension period (week 6) using 24 hr dietary recall. A dietary analysis program will be used to calculate intake from food and total dietary intake.	1week	No
Secondary	Compliance with ONS	Participants' compliance with ONS (percentage of bottle consumed), will be recorded on a daily basis by the participant or their carer throughout the study.	1week	No
Secondary	ONS Acceptability (taste, aroma) and ONS Preference (which type is preferred)	The acceptability (taste, texture, aroma) and preference for the type of ONS will be assessed (using Yes/No questions and visual analogue scales) to gather patients feedback on the acceptability the the supplements	1week	No
Secondary	Appetite	The effect of the ONS on hunger and fullness will be assessed by questionnaire using visual analogue scales at baseline (day 1), at the end of week 1, at the end of week 2 and at the end of the study (week 6).	1week	No
Secondary	Anthropometry	At baseline as part of screening with MUST, at the end of week 1, at the end of week 2 and at the end of the study (week 6), body weight (kg) will be measured using standard methods and body mass index (kg/m2) calculated. Body weight will be measured to the nearest 0.1kg using a weighing scale or weighing chair without shoes or heavy clothing.	6weeks	No
Secondary	Muscle Strength (Hand Grip Strength)	Hand grip strength will be measured at baseline (day 1), at the end of week 2 and at the end of the study (week 6) using a handgrip dynamometer.	6weeks	No
Secondary	Gastro-intestinal (GI) tolerance	Gastro-intestinal tolerance will be assessed at baseline (day 1), at the end of week 1, at the end of week 2 and the end of week 6 for 1 day, using a standardized GI tolerance questionnaire.	6weeks	Yes