Nutritional Supplement Compliance Study

Phase 3

Completed

• Conditions: Undernutrition
• Interventions: Dietary Supplement: Standard Oral Nutritional Supplement (ONS); Dietary Supplement: High energy Oral Nutritional Supplement (ONS)

• Registration Number: NCT00688649
• Lead Sponsor: Nutricia UK Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-27
• Study First Submitted QC: 2008-05-29
• Study First Posted: 2008-06-03
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-03
• Last Update Posted: 2009-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Standard Oral Nutritional Supplement (ONS)	Standard ONS
2	High energy Oral Nutritional Supplement (ONS)	High Energy ONS

Primary Outcome Measures

Name	Time	Method
Nutrient intake (energy, protein and micronutrients)	4 weeks

Secondary Outcome Measures

Name	Time	Method
Compliance with ONS	4 weeks

Trial Locations

Locations (1)

Royal United Hospital, Nutrition and Dietetics Dept; 🇬🇧 Bath, Wiltshire, United Kingdom