NCT01261663

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2010

Completed
16 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 6, 2013

Status Verified

November 1, 2013

Enrollment Period

2.8 years

First QC Date

December 14, 2010

Last Update Submit

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.

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

Interventions

NOS intake either at end of meals or as snackings.

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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

Locations