INAPEN Protocol for Impact of Breakfast Improvement (INAPEN)
Recruitment status was: Recruiting
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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 Intervention Model: Parallel Assignment Masking: None (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) |
- serum transthyretin (prealbumin) concentration [ Time Frame: changes between D0 to D7 between the 2 cohorts ]Improvement of serum transthyretin (prealbumin) concentration changes between D0 to D7
- serum albumin concentration changes and length of stay [ Time Frame: Changes between the 2 cohorts ]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
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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.
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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
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01342861
| 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 |
| 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 | |
More Information
Publications:
| Responsible Party: | Xavier Forceville, MD, PhD, CHdMeaux |
| ClinicalTrials.gov Identifier: | NCT01342861 History of Changes |
| Other Study ID Numbers: |
INAPEN |
| First Submitted: | April 26, 2011 |
| First Posted: | April 27, 2011 |
| Last Update Posted: | April 27, 2011 |
| Last Verified: | April 2011 |
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 |