Clinical trial NCT01261663: Impact of the Time of Oral Nutritional Supplements (ONS) Consumption on Daily Alimentary Intakes of Malnourished Elderly
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition in the Elderly
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2010-12-16
Enrollment: 48
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Malnourished elderly (age \>=70 y) hospitalised in long term care unit (LTCU)having a NOS medical prescription

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.

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 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.

Primary outcomes:
measure: Total daily alimentary intakes
timeFrame: daily, for 20 consecutive days
Secondary outcomes:
measure: Protein, carbohydrates and lipids intakes
timeFrame: daily, for 20 consecutive days
Other outcomes:
Locations:
city: Limoges
country: France
facility: Unité de Nutrition - Service hépato-gastro-entérologie
Study officials:
References: