Nutritional Supplement Compliance Study (NSCS)
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|ClinicalTrials.gov Identifier: NCT00688649|
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : February 4, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Undernutrition||Dietary Supplement: Standard Oral Nutritional Supplement (ONS) Dietary Supplement: High energy Oral Nutritional Supplement (ONS)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||An Investigation of the Effects of Different Modes of Delivery of Oral Nutritional Supplements in Participants at Risk of Malnutrition - A Pilot Study|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
Active Comparator: 1
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)
Active Comparator: 2
High Energy ONS
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)
- Nutrient intake (energy, protein and micronutrients) [ Time Frame: 4 weeks ]
- Compliance with ONS [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688649
|Royal United Hospital, Nutrition and Dietetics Dept|
|Bath, Wiltshire, United Kingdom, BA1 3Ng|
|Study Director:||Lucio Fumi||Nutricia UK|