An Investigation of the Efficacy of Oral Nutritional Supplements in Participants at Risk of Malnutrition
1 other identifier
interventional
60
1 country
1
Brief Summary
This study aims to investigate the efficacy of high energy, low volume oral nutritional supplements (ONS) compared to equivalent standard ONS (control) to maximize nutrient intake, compliance, gastro intestinal tolerance and function, in participants at risk of malnutrition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 25, 2010
CompletedFirst Posted
Study publicly available on registry
March 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedNovember 13, 2014
November 1, 2014
3.8 years
February 25, 2010
November 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Nutrient intake (energy, protein and micronutrients)
Dietary intake, including the intake of all foods, drinks and ONS will be recorded at baseline (day 1), at the end of week 1, at the end of week 2 and at the end of the optional extension period (week 6) using 24 hr dietary recall. A dietary analysis program will be used to calculate intake from food and total dietary intake.
1week
Secondary Outcomes (6)
Compliance with ONS
1week
ONS Acceptability (taste, aroma) and ONS Preference (which type is preferred)
1week
Appetite
1week
Anthropometry
6weeks
Muscle Strength (Hand Grip Strength)
6weeks
- +1 more secondary outcomes
Study Arms (2)
Standard ONS
ACTIVE COMPARATORHigh Energy, Low volume ONS
EXPERIMENTALHigh energy, low volume ONS
Interventions
Standard ONS
High energy, low volume ONS
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nutricia UK Ltdlead
Study Sites (1)
Dietetics Dept, Great Western Hospital
Swindon, Wiltshire, SN3 6BB, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca Stratton
Nutricia UK Ltd
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2010
First Posted
March 3, 2010
Study Start
February 1, 2010
Primary Completion
December 1, 2013
Study Completion
June 1, 2014
Last Updated
November 13, 2014
Record last verified: 2014-11