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Nutritional Supplement Compliance Study (NSCS)

This study has been completed.
Information provided by:
Nutricia UK Ltd Identifier:
First received: May 27, 2008
Last updated: February 3, 2009
Last verified: February 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 Intervention Phase
Dietary Supplement: Standard Oral Nutritional Supplement (ONS)
Dietary Supplement: High energy Oral Nutritional Supplement (ONS)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Nutricia UK Ltd:

Primary Outcome Measures:
  • Nutrient intake (energy, protein and micronutrients) [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Compliance with ONS [ Time Frame: 4 weeks ]

Enrollment: 80
Study Start Date: May 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Standard ONS
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)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00688649

United Kingdom
Royal United Hospital, Nutrition and Dietetics Dept
Bath, Wiltshire, United Kingdom, BA1 3Ng
Sponsors and Collaborators
Nutricia UK Ltd
Study Director: Lucio Fumi Nutricia UK
  More Information

Responsible Party: Dr Gary Hubbard, Senior Clinical Research Advisor, Nutricia UK Identifier: NCT00688649     History of Changes
Other Study ID Numbers: NCC200
Study First Received: May 27, 2008
Last Updated: February 3, 2009

Additional relevant MeSH terms:
Nutrition Disorders processed this record on May 25, 2017