INAPEN Protocol for Impact of Breakfast Improvement

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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)

Conditions
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Hospital Undernutrition, Malnutrition, Nutritional Deficiency

Intervention / Treatment
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* Dietary Supplement: Addition of protein (milky food in the breakfast)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients hospitalized for 8 days or more in the participant wards and capable of eating the proposed breakfast. According to the current care procedure, patients receiving an information document and offered the possibility of refusal. Exclusion Criteria: End of life defined as an absence of curative treatment (limitation of care) Enteral or parenteral nutrition Need for limitations on oral nutrition (i.e. post-surgery)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Observational period<br>A first period of follow-up on the 400 patients was designed to survey and evaluate current nutrition administration policy | Dietary Supplement: Addition of protein (milky food in the breakfast)<br>* 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.<br>|
| Experimental: Intervention period<br>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. | Dietary Supplement: Addition of protein (milky food in the breakfast)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum transthyretin (prealbumin) concentration | Improvement of serum transthyretin (prealbumin) concentration changes between D0 to D7 | changes between D0 to D7 between the 2 cohorts | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum albumin concentration changes and length of stay | serum albumin concentration changes between D0 to D7, length of stay | Changes between the 2 cohorts | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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protein supplementation, caloric intake, breakfast, transthyretin (prealbumin), albumin, Length of stay