Malnutrition Clinical Trial
Official title:
INAPEN Protocol for Impact of Breakfast Improvement on the Nutritional Status of Hospitalized Patients (INcidence de l'Amélioration du Petit-déjeuner Sur l'Etat Nutritinonel Des Patients hospitalisés)
Hospital undernutrition is a common health problem [1]. As a countermeasure, French
hospitals have created a system of cross-function committees for feeding and nutrition
called CLANs [Comité de Liaison pour l'alimentation et la nutrition] [2]. Potential actions
for improving patient nutritional status include improving the characteristics of the food
provided to increase both protein and calorie intake in at-risk patients that do not require
enteral or parenteral nutrition. Looking at the various daily meals, the investigators
considered that breakfast following the night fast would be the easiest meal to improve .
Condition Intervention Phase Patients scheduled for hospitalization of over 4 days Addition
of protein (milky food in the breakfast) Current care
INAPEN protocol for impact of breakfast improvement on the nutritional status of
hospitalized patients (INcidence de l'Amélioration du Petit-déjeuner sur l'Etat Nutritinonel
des patients hospitalisés)
Sponsored by Meaux Hospital (Centre Hospitalier de Meaux),
Financing: unrestricted grant from the French speaking society for enteral and parenteral
nutrition [SFNEP: Société Francophone de nutrition entérale et parentérale].
Information provided by Meaux Hospital Center (Centre Hospitalier de Meaux) as per the
protocol submitted to the SFNEP in 2009.
Purpose
Hospital undernutrition is a common health problem [1]. As a countermeasure, French
hospitals have created a system of cross-function committees for feeding and nutrition
called CLANs [Comité de Liaison pour l'alimentation et la nutrition] [2]. Potential actions
for improving patient nutritional status include improving the characteristics of the food
provided to increase both protein and calorie intake in at-risk patients that do not require
enteral or parenteral nutrition. Looking at the various daily meals, we considered that
breakfast following the night fast would be the easiest meal to improve .
Condition Intervention Phase Patients scheduled for hospitalization of over 4 days Addition
of protein (milky food in the breakfast) Current care
Study Type: Interventional study in current care
Study design: Sequential cohorts, Efficacy study
Official title: Inapen Impact of breakfast improvement on the nutritional status of
hospitalized patients (Incidence de l'amélioration du petit-déjeuner sur l'état nutritionnel
des patients hospitalisés).
Further study details:
Primary outcome: Improvement of serum transthyretin (prealbumin) concentration changes
between D0 to D7 Secondary outcomes: serum albumin concentration changes between D0 to D7,
length of stay
Expected total enrollment: 800 patients (400 patients x 2).
Study start date: October 2009 Expected inclusion completion date: June 2011
Rationale:
It has long been known that more than half of hospitalized patients suffer from
undernutrition [3-5]), consequently increasing length of stay of 2 to 6 days and morbidity
[3]. Early nutrition has been shown to reduce length of stay and hospitalization costs [3,
6], but is mostly based on early enteral or parenteral nutrition. Our purpose was to
evaluate the impact of an improved oral nutrition in mildly-challenged hospitalized
patients. It is widely accepted that breakfast should deliver 25% of energy intake and
nutritional requirements (ref4). A preliminary study found that the total protein and energy
impact of breakfast in Meaux hospital was 4 g protein and 346 Kcal of total energy intake,
whereas French institutional catering recommendations on nutrition (Groupe d'Etude des
Marchés de Restauration Collective et de Nutrition, GEM RCN) stipulate 7.75 g of protein and
403 Kcal of energy.
The main purpose of this study is to evaluate the efficacy of additional protein (adding
milky food to the breakfast) in order to deliver an optimized protein and energy intake of
15.75 g and 559 Kcal, respectively.
A first period of follow-up on the 400 patients was designed to survey and evaluate current
nutrition administration policy. The second period of follow-up on the 400 patients was
designed to evaluate the impacts of adding milky food to the breakfast and of educating
health care professionals on the early detection of undernutrition. Efficacy will be
evaluated based on increase in transthyretin concentrations, with special focus given to
length of stay as a secondary end-point.
Eligibility Ages eligible for study: > 18 years. Both genders eligible for study.
Location and Contact Information France Rheumatology, Cardiology, Neurology, Pneumology
departements Vascular and orthopedic surgery department
Study directorship and principal investigators Xavier Forceville, MD, PhD, Principal
investigator Francois Thuillier, Pharmacist, CLAN chairman Karell Prieux-Lucas, Investigator
Samia Touati, MD, Investigator
Further information
Study ID Number: CNIL : 909314 Health Authority: France CCTIRS : 09.358 (2009, september
10Th) Ethical committee: France, Ile-de-France XI (Saint Germain-en-Laye), August 17th, 2009
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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