Back to resultsNutritional Supplement Compliance Study (NSCS)
Primary Purpose
Undernutrition
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Standard Oral Nutritional Supplement (ONS)
High energy Oral Nutritional Supplement (ONS)
Sponsored by
About this trial
This is an interventional treatment trial for Undernutrition
Eligibility Criteria
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
Sites / Locations
- Royal United Hospital, Nutrition and Dietetics Dept
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Standard ONS
High Energy ONS
Outcomes
Primary Outcome Measures
Nutrient intake (energy, protein and micronutrients)
Secondary Outcome Measures
Compliance with ONS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00688649
Brief Title
Nutritional Supplement Compliance Study
Acronym
NSCS
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 Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nutricia UK Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Undernutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Standard ONS
Arm Title
2
Arm Type
Active Comparator
Arm Description
High Energy ONS
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard Oral Nutritional Supplement (ONS)
Intervention Description
Standard energy, oral nutritional supplement (a milk style nutritional supplement (1.5kcal/ml, 200ml) containing protein, fat, carbohydrate and micronutrients)
Intervention Type
Dietary Supplement
Intervention Name(s)
High energy Oral Nutritional Supplement (ONS)
Intervention Description
High Energy nutritional supplement (a milk style nutritional supplement (2.4kcal/ml, 125ml) containing protein, fat, carbohydrate and micronutrients)
Primary Outcome Measure Information:
Title
Nutrient intake (energy, protein and micronutrients)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Compliance with ONS
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucio Fumi
Organizational Affiliation
Nutricia UK
Official's Role
Study Director
Facility Information:
Facility Name
Royal United Hospital, Nutrition and Dietetics Dept
City
Bath
State/Province
Wiltshire
ZIP/Postal Code
BA1 3Ng
Country
United Kingdom
12. IPD Sharing Statement
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Nutritional Supplement Compliance Study
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