NCT00688649

Nutritional Supplement Compliance Study

An Investigation of the Effects of Different Modes of Delivery of Oral Nutritional Supplements in Participants at Risk of Malnutrition - A Pilot Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Nutricia UK Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Undernutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Standard Oral Nutritional Supplement (ONS)	Standard energy, oral nutritional supplement (a milk style nutritional supplement (1.5kcal/ml, 200ml) containing protein, fat, carbohydrate and micronutrients)
DIETARY_SUPPLEMENT	High energy Oral Nutritional Supplement (ONS)	High Energy nutritional supplement (a milk style nutritional supplement (2.4kcal/ml, 125ml) containing protein, fat, carbohydrate and micronutrients)

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2008-06-03
• Last updated: 2009-02-04

Locations

1 site across 1 country: United Kingdom