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OpenTrials
Completed

NCT Number: NCT00688649

Nutritional Supplement Compliance Study

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.

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Key information

Conditions

Undernutrition Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal United Hospital, Nutrition and Dietetics Dept

Bath, Wiltshire, BA1 3Ng, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Oral Nutritional Supplement (ONS)

Dietary Supplement

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)

Dietary Supplement

High Energy nutritional supplement (a milk style nutritional supplement (2.4kcal/ml, 125ml) containing protein, fat, carbohydrate and micronutrients)

Primary outcomes

  1. Nutrient intake (energy, protein and micronutrients)

    Time frame: 4 weeks

Secondary outcomes

  1. Compliance with ONS

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Nutricia UK Ltd

Industry

Registry information

Official study title

An Investigation of the Effects of Different Modes of Delivery of Oral Nutritional Supplements in Participants at Risk of Malnutrition - A Pilot Study

Acronym: NSCS

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 3, 2008
Registry last updated
Feb 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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