Impact of the Time of Oral Nutritional Supplements (ONS) Consumption on Daily Alimentary Intakes of Malnourished Elderly
ACTICLAN
1 other identifier
observational
48
1 country
1
Brief Summary
Malnutrition is a severe comorbidity in hospitalised patients, especially in elderly. The consumption of Oral Nutritional Supplements (NOS) is one of several tools for fighting against malnutrition. Their use is easy, and framed by recent French recommendations suggesting to propose NOS at end of meals or as snacking . Nevertheless, there is no scientific data to affirm which is the best of these two hypothesis in elderly hospitalised in Long Term Care Unit(LTCU) . Moreover, a preliminary survey of NOS consumption in LTCU in Limoges university hospital showed some problems about the mode of supplying NOS, partially linked with an insufficiency for paramedical staff in realizing importance of NOS. However, the effect of time of supplying NOS on total food consumption had not been evaluated in this first study. The new one will include 48 malnourished elderly patients in two LTCU and having a prescription of NOS. They will receive them at the same quantity during the whole study either firstly at end of meals (10 days) and secondly as snackings (10 days), or conversely. Order of choice will be randomised. Total daily alimentary intakes will be noted by paramedical staff of the two units, and translated by dieticians in daily energy, protein, carbohydrates and lipids intakes. The time of supplying NOS will be confronted with these intakes, in order to precise the best one.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2011
Typical duration for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2010
CompletedFirst Posted
Study publicly available on registry
December 16, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedNovember 6, 2013
November 1, 2013
2.8 years
December 14, 2010
November 4, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Total daily alimentary intakes
daily, for 20 consecutive days
Secondary Outcomes (1)
Protein, carbohydrates and lipids intakes
daily, for 20 consecutive days
Study Arms (1)
NOS intake either at end of meals or as snackings.
Interventions
Eligibility Criteria
Malnourished elderly (age \>=70 y) hospitalised in long term care unit (LTCU)having a NOS medical prescription
You may qualify if:
- Malnourished elderly (age \>=70 y) hospitalised in LTCU
- having a NOS medical prescription o
You may not qualify if:
- Non malnourished patients in LTCU,
- age \<70.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unité de Nutrition - Service hépato-gastro-entérologie
Limoges, 87000, France
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2010
First Posted
December 16, 2010
Study Start
January 1, 2011
Primary Completion
November 1, 2013
Study Completion
June 1, 2014
Last Updated
November 6, 2013
Record last verified: 2013-11