ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01261663
Recruitment Status : Completed
First Posted : December 16, 2010
Last Update Posted : November 6, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

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.

Condition or disease Intervention/treatment
Malnutrition in the Elderly Other: oral nutritional energy and protein enriched supplement (NOS)

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.

Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Impact of the Time of Oral Nutritional Supplements (ONS) Consumption on Daily Alimentary Intakes of Malnourished Elderly Subjects Hospitalized in Long Term Care Unit (LTCU)
Study Start Date : January 2011
Actual Primary Completion Date : November 2013
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
NOS intake either at end of meals or as snackings. Other: oral nutritional energy and protein enriched supplement (NOS)



Primary Outcome Measures :
  1. Total daily alimentary intakes [ Time Frame: daily, for 20 consecutive days ]

Secondary Outcome Measures :
  1. Protein, carbohydrates and lipids intakes [ Time Frame: daily, for 20 consecutive days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01261663


Locations
France
Unité de Nutrition - Service hépato-gastro-entérologie
Limoges, France, 87000
Sponsors and Collaborators
University Hospital, Limoges

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01261663     History of Changes
Other Study ID Numbers: I09017
First Posted: December 16, 2010    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders