A Phase 3 interventional study of Standard Oral Nutritional Supplement (ONS) and High energy Oral Nutritional Supplement (ONS) in Undernutrition, sponsored by Nutricia UK Ltd. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-02-04.
Sponsored by Nutricia UK Ltd · Phase 3, Interventional, and Treatment
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.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's enrollment of 80 is below the median of 90 across 1,134 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →Nutricia UK Ltd is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard ONS
Dietary Supplement: Standard Oral Nutritional Supplement (ONS)
High Energy ONS
Dietary Supplement: High energy Oral Nutritional Supplement (ONS)
Standard energy, oral nutritional supplement (a milk style nutritional supplement (1.5kcal/ml, 200ml) containing protein, fat, carbohydrate and micronutrients)
High Energy nutritional supplement (a milk style nutritional supplement (2.4kcal/ml, 125ml) containing protein, fat, carbohydrate and micronutrients)
Nutrient intake (energy, protein and micronutrients)
Time frame: 4 weeks
Compliance with ONS
Time frame: 4 weeks
This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.
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Nutricia UK Ltd