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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01261663
First received: December 14, 2010
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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 Intervention
Malnutrition in the Elderly
Other: oral nutritional energy and protein enriched supplement (NOS)

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • Total daily alimentary intakes [ Time Frame: daily, for 20 consecutive days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Protein, carbohydrates and lipids intakes [ Time Frame: daily, for 20 consecutive days ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: January 2011
Estimated Study Completion Date: June 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
NOS intake either at end of meals or as snackings. 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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01261663

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

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01261663     History of Changes
Other Study ID Numbers: I09017
Study First Received: December 14, 2010
Last Updated: November 4, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on October 01, 2014