Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Nutritional Supplement Compliance Study (NSCS)

This study has been completed.
Sponsor:
Information provided by:
Nutricia UK Ltd
ClinicalTrials.gov Identifier:
NCT00688649
First received: May 27, 2008
Last updated: February 3, 2009
Last verified: February 2009
  Purpose

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
Undernutrition
Dietary Supplement: Standard Oral Nutritional Supplement (ONS)
Dietary Supplement: High energy Oral Nutritional Supplement (ONS)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compliance with ONS [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dr Gary Hubbard, Senior Clinical Research Advisor, Nutricia UK
ClinicalTrials.gov Identifier: NCT00688649     History of Changes
Other Study ID Numbers: NCC200
Study First Received: May 27, 2008
Last Updated: February 3, 2009
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on November 24, 2014