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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'lastUpdateSubmitDate': '2011-04-26', 'studyFirstSubmitDate': '2011-04-26', 'studyFirstSubmitQcDate': '2011-04-26', 'lastUpdatePostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum transthyretin (prealbumin) concentration', 'timeFrame': 'changes between D0 to D7 between the 2 cohorts', 'description': 'Improvement of serum transthyretin (prealbumin) concentration changes between D0 to D7'}], 'secondaryOutcomes': [{'measure': 'serum albumin concentration changes and length of stay', 'timeFrame': 'Changes between the 2 cohorts', 'description': 'serum albumin concentration changes between D0 to D7, length of stay'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['protein supplementation', 'caloric intake', 'breakfast', 'transthyretin (prealbumin)', 'albumin', 'Length of stay'], 'conditions': ['Hospital Undernutrition', 'Malnutrition', 'Nutritional Deficiency']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "Rapport complet de l'ANAES :Evaluation diagnostique de la dénutrition protéino-énergétique des adultes hospitalises. September 2003; http://www.has-sante.fr"}, {'pmid': '3138447', 'type': 'BACKGROUND', 'citation': 'Reilly JJ Jr, Hull SF, Albert N, Waller A, Bringardener S. Economic impact of malnutrition: a model system for hospitalized patients. JPEN J Parenter Enteral Nutr. 1988 Jul-Aug;12(4):371-6. doi: 10.1177/0148607188012004371.'}, {'type': 'BACKGROUND', 'citation': "Circulaire DHOS/E1 N°2002-186 29/03/2002 relative à l'alimentation et la nutrition dans les établissements de santé: J off de la République Française 18/04/2002"}, {'pmid': '12549591', 'type': 'BACKGROUND', 'citation': 'Kudsk KA, Tolley EA, DeWitt RC, Janu PG, Blackwell AP, Yeary S, King BK. Preoperative albumin and surgical site identify surgical risk for major postoperative complications. JPEN J Parenter Enteral Nutr. 2003 Jan-Feb;27(1):1-9. doi: 10.1177/014860710302700101.'}, {'pmid': '10895110', 'type': 'BACKGROUND', 'citation': 'Edington J, Boorman J, Durrant ER, Perkins A, Giffin CV, James R, Thomson JM, Oldroyd JC, Smith JC, Torrance AD, Blackshaw V, Green S, Hill CJ, Berry C, McKenzie C, Vicca N, Ward JE, Coles SJ. Prevalence of malnutrition on admission to four hospitals in England. The Malnutrition Prevalence Group. Clin Nutr. 2000 Jun;19(3):191-5. doi: 10.1054/clnu.1999.0121.'}, {'pmid': '21378250', 'type': 'BACKGROUND', 'citation': 'Somanchi M, Tao X, Mullin GE. The facilitated early enteral and dietary management effectiveness trial in hospitalized patients with malnutrition. JPEN J Parenter Enteral Nutr. 2011 Mar;35(2):209-16. doi: 10.1177/0148607110392234.'}]}, 'descriptionModule': {'briefSummary': "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 .\n\nCondition Intervention Phase Patients scheduled for hospitalization of over 4 days Addition of protein (milky food in the breakfast) Current care", 'detailedDescription': "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)\n\nSponsored by Meaux Hospital (Centre Hospitalier de Meaux),\n\nFinancing: unrestricted grant from the French speaking society for enteral and parenteral nutrition \\[SFNEP: Société Francophone de nutrition entérale et parentérale\\].\n\nInformation provided by Meaux Hospital Center (Centre Hospitalier de Meaux) as per the protocol submitted to the SFNEP in 2009.\n\nPurpose\n\nHospital 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 .\n\nCondition Intervention Phase Patients scheduled for hospitalization of over 4 days Addition of protein (milky food in the breakfast) Current care\n\nStudy Type: Interventional study in current care\n\nStudy design: Sequential cohorts, Efficacy study\n\nOfficial 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).\n\nFurther study details:\n\nPrimary 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\n\nExpected total enrollment: 800 patients (400 patients x 2).\n\nStudy start date: October 2009 Expected inclusion completion date: June 2011\n\nRationale:\n\nIt 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.\n\nThe 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.\n\nA 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.\n\nEligibility Ages eligible for study: \\> 18 years. Both genders eligible for study.\n\nLocation and Contact Information France Rheumatology, Cardiology, Neurology, Pneumology departements Vascular and orthopedic surgery department\n\nStudy directorship and principal investigators Xavier Forceville, MD, PhD, Principal investigator Francois Thuillier, Pharmacist, CLAN chairman Karell Prieux-Lucas, Investigator Samia Touati, MD, Investigator\n\nFurther information\n\nStudy 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients hospitalized for 8 days or more in the participant wards and capable of eating the proposed breakfast.\n\nAccording to the current care procedure, patients receiving an information document and offered the possibility of refusal.\n\nExclusion Criteria:\n\n* End of life defined as an absence of curative treatment (limitation of care)\n* Enteral or parenteral nutrition\n* Need for limitations on oral nutrition (i.e. post-surgery)'}, 'identificationModule': {'nctId': 'NCT01342861', 'acronym': 'INAPEN', 'briefTitle': 'INAPEN Protocol for Impact of Breakfast Improvement', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Meaux'}, 'officialTitle': "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)", 'orgStudyIdInfo': {'id': 'INAPEN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Observational period', 'description': 'A first period of follow-up on the 400 patients was designed to survey and evaluate current nutrition administration policy', 'interventionNames': ['Dietary Supplement: Addition of protein (milky food in the breakfast)']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention period', 'description': '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.', 'interventionNames': ['Dietary Supplement: Addition of protein (milky food in the breakfast)']}], 'interventions': [{'name': 'Addition of protein (milky food in the breakfast)', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Intervention period', 'Observational period']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77', 'city': 'Meaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Xavier Forceville, MD, PhD', 'role': 'CONTACT', 'email': 'x-forceville@ch-meaux.fr', 'phone': '164351176', 'phoneExt': '33'}, {'name': 'François Thuillier, PD', 'role': 'CONTACT', 'email': 'f-thuillier@ch-meaux.fr', 'phone': '164351106', 'phoneExt': '33'}, {'name': 'Xavier Forceville, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Samia Touati, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Karell Prieux - Lucas, Dietitian', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de Meaux', 'geoPoint': {'lat': 48.96014, 'lon': 2.87885}}], 'centralContacts': [{'name': 'Xavier Forceville, MD, PhD', 'role': 'CONTACT', 'email': 'x-forceville@ch-meaux.fr', 'phone': '164351176', 'phoneExt': '33'}, {'name': 'François Thuillier, PD', 'role': 'CONTACT', 'email': 'f-thuillier@ch-meaux.fr', 'phone': '164351106', 'phoneExt': '33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Meaux', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Xavier Forceville, MD, PhD', 'oldOrganization': 'CHdMeaux'}}}}