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INAPEN Protocol for Impact of Breakfast Improvement

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Centre Hospitalier de Meaux.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centre Hospitalier de Meaux
ClinicalTrials.gov Identifier:
NCT01342861
First received: April 26, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  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, 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
Hospital Undernutrition
Malnutrition
Nutritional Deficiency
 Dietary Supplement: Addition of protein (milky food in the breakfast)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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)

Resource links provided by NLM:

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Further study details as provided by Centre Hospitalier de Meaux:

Primary Outcome Measures:
  • serum transthyretin (prealbumin) concentration [ Time Frame: changes between D0 to D7 between the 2 cohorts ] [ Designated as safety issue: No ]
    Improvement of serum transthyretin (prealbumin) concentration changes between D0 to D7


Secondary Outcome Measures:
  • serum albumin concentration changes and length of stay [ Time Frame: Changes between the 2 cohorts ] [ Designated as safety issue: No ]
    serum albumin concentration changes between D0 to D7, length of stay


Estimated Enrollment: 800
Study Start Date: October 2009
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Observational period
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)
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.
Experimental: Intervention period
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)
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342861

Contacts
Contact: Xavier Forceville, MD, PhD 164351176 ext 33 x-forceville@ch-meaux.fr
Contact: François Thuillier, PD 164351106 ext 33 f-thuillier@ch-meaux.fr

Locations
France
Centre Hospitalier de Meaux Recruiting
Meaux, France, 77
Contact: Xavier Forceville, MD, PhD     164351176 ext 33     x-forceville@ch-meaux.fr    
Contact: François Thuillier, PD     164351106 ext 33     f-thuillier@ch-meaux.fr    
Principal Investigator: Xavier Forceville, MD, PhD            
Sub-Investigator: Samia Touati, MD            
Sub-Investigator: Karell Prieux - Lucas, Dietitian            
Sponsors and Collaborators
Centre Hospitalier de Meaux
  More Information

Publications:

Responsible Party: Xavier Forceville, MD, PhD, CHdMeaux
ClinicalTrials.gov Identifier: NCT01342861     History of Changes
Other Study ID Numbers: INAPEN
Study First Received: April 26, 2011
Last Updated: April 26, 2011
Health Authority: Health Authority: France CCTIRS : 09.358 (2009, september 10Th)

Keywords provided by Centre Hospitalier de Meaux:
protein supplementation
caloric intake
breakfast
 transthyretin (prealbumin)
albumin
Length of stay

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on June 17, 2013