Nutritional Supplement Compliance Study

Undernutrition Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688649
• Other study ID #: NCC200
• Status: Completed
• Phase: Phase 3
• First received: May 27, 2008
• Last updated: February 3, 2009
• Start date: May 2008
• Est. completion date: January 2009

Study information

• Verified date: February 2009
• Source: Nutricia UK Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition
• Undernutrition

Intervention

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)
• 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)

Locations

Country	Name	City	State
United Kingdom	Royal United Hospital, Nutrition and Dietetics Dept	Bath	Wiltshire

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia UK Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutrient intake (energy, protein and micronutrients)		4 weeks	No
Secondary	Compliance with ONS		4 weeks	No