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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
Sponsor:
Information provided by:
Nutricia UK Ltd

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.


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : May 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)



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

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


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

Information from the National Library of Medicine

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


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

Responsible Party: Dr Gary Hubbard, Senior Clinical Research Advisor, Nutricia UK
ClinicalTrials.gov Identifier: NCT00688649     History of Changes
Other Study ID Numbers: NCC200
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: February 4, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders