Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-29 @ 11:03 AM
Study NCT ID:
NCT01342861
Status:
UNKNOWN
Last Update Posted:
2011-04-27
First Post:
2011-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
INAPEN Protocol for Impact of Breakfast Improvement
Sponsor:
Centre Hospitalier de Meaux
Organization:
Study Overview
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)
Status:
UNKNOWN
Status Verified Date:
2011-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INAPEN
Brief Summary:
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
Condition Intervention Phase Patients scheduled for hospitalization of over 4 days Addition of protein (milky food in the breakfast) Current care
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: