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CompletedNCT01261663ACTICLANUpdated Nov 6, 2013

Impact of the Time of Oral Nutritional Supplements (ONS) Consumption on Daily Alimentary Intakes of Malnourished Elderly

An observational study in Malnutrition in the Elderly, sponsored by University Hospital, Limoges. Completed at 1 site in France. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2013-11-06.

Sponsored by University Hospital, Limoges · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
48
Ages
70 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Malnutrition in the Elderly

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03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's planned enrollment of 48 is below the median of 203 across 388 observational studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

University Hospital, Limoges is the lead sponsor of 255 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Malnourished elderly (age >=70 y) hospitalised in long term care unit (LTCU)having a NOS medical prescription

Inclusion criteria

  • Malnourished elderly (age >=70 y) hospitalised in LTCU
  • having a NOS medical prescription o

Exclusion criteria

Exclusion Criteria:

  • Non malnourished patients in LTCU,
  • age \<70.
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
48 participants (estimated)

Groups and cohorts

  • NOS intake either at end of meals or as snackings.

    Other: oral nutritional energy and protein enriched supplement (NOS)

Interventions

  • Otheroral nutritional energy and protein enriched supplement (NOS)
06

What researchers measure

Primary outcomes

  1. Total daily alimentary intakes

    Time frame: daily, for 20 consecutive days

Secondary outcomes

  1. Protein, carbohydrates and lipids intakes

    Time frame: daily, for 20 consecutive days

07

Study locations

1 site
  • Unité de Nutrition - Service hépato-gastro-entérologie
    Limoges, 87000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01261663
Lead sponsor
University Hospital, Limoges
Responsible party
Sponsor
First posted
Dec 16, 2010
Start date
Jan 2011
Primary completion
Nov 2013
Completion
Jun 2014
Last update
Nov 6, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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