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

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)

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 Overview

• Status: Completed
• Conditions: Malnutrition in the Elderly
• Intervention / Treatment: 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
• Enrollment (Anticipated): 48

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total daily alimentary intakes	daily, for 20 consecutive days

Secondary Outcome Measures

Outcome Measure	Time Frame
Protein, carbohydrates and lipids intakes	daily, for 20 consecutive days

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion: June 1, 2014

Study Registration Dates

• First Submitted: December 14, 2010
• First Submitted That Met QC Criteria: December 15, 2010
• First Posted (Estimate): December 16, 2010

Study Record Updates

• Last Update Posted (Estimate): November 6, 2013
• Last Update Submitted That Met QC Criteria: November 4, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: I09017