Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-03-05 @ 6:31 AM
Study NCT ID:
NCT03083912
Status:
COMPLETED
Last Update Posted:
2017-11-28
First Post:
2016-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of High Protein, High-calorie Oral Nutritional Supplementation in Malnourished Elderly in Nursing Homes.
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 291}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-24', 'studyFirstSubmitDate': '2016-10-25', 'studyFirstSubmitQcDate': '2017-03-13', 'lastUpdatePostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of drinking bottles during the study.', 'timeFrame': '3 months', 'description': 'Evaluate the compliance with the oral nutritional supplementation'}], 'primaryOutcomes': [{'measure': 'Improve weight', 'timeFrame': '3 months', 'description': 'Difference between the weight of the residents at the beginning and at the end of the study'}], 'secondaryOutcomes': [{'measure': 'SPPB scale', 'timeFrame': '3 months', 'description': 'Functional status at the end of the study'}, {'measure': 'Barthel index', 'timeFrame': '3 months', 'description': 'Ability in Activities of Daily Living at the end of the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Malnutrition', 'Disability', 'Oral Nutritional Supplementation'], 'conditions': ['Other Malnutrition']}, 'referencesModule': {'references': [{'pmid': '23415063', 'type': 'BACKGROUND', 'citation': 'Malafarina V, Uriz-Otano F, Gil-Guerrero L, Iniesta R. The anorexia of ageing: physiopathology, prevalence, associated comorbidity and mortality. A systematic review. Maturitas. 2013 Apr;74(4):293-302. doi: 10.1016/j.maturitas.2013.01.016. Epub 2013 Feb 13.'}, {'pmid': '24246053', 'type': 'BACKGROUND', 'citation': 'van Nie-Visser NC, Meijers J, Schols J, Lohrmann C, Bartholomeyczik S, Spreeuwenberg M, Halfens R. Which characteristics of nursing home residents influence differences in malnutrition prevalence? An international comparison of The Netherlands, Germany and Austria. Br J Nutr. 2014 Mar 28;111(6):1129-36. doi: 10.1017/S0007114513003541. Epub 2013 Nov 18.'}, {'pmid': '27068239', 'type': 'BACKGROUND', 'citation': 'Salva A, Serra-Rexach JA, Artaza I, Formiga F, Rojano I Luque X, Cuesta F, Lopez-Soto A, Masanes F, Ruiz D, Cruz-Jentoft AJ. [Prevalence of sarcopenia in Spanish nursing homes: Comparison of the results of the ELLI study with other populations]. Rev Esp Geriatr Gerontol. 2016 Sep-Oct;51(5):260-4. doi: 10.1016/j.regg.2016.02.004. Epub 2016 Apr 9. Spanish.'}, {'pmid': '26025067', 'type': 'BACKGROUND', 'citation': 'Camina-Martin MA, de Mateo-Silleras B, Malafarina V, Lopez-Mongil R, Nino-Martin V, Lopez-Trigo JA, Redondo-del-Rio MP. Nutritional status assessment in geriatrics: Consensus declaration by the Spanish Society of Geriatrics and Gerontology Nutrition Work Group. Maturitas. 2015 Jul;81(3):414-9. doi: 10.1016/j.maturitas.2015.04.018. Epub 2015 May 14.'}, {'pmid': '22980996', 'type': 'BACKGROUND', 'citation': 'Malafarina V, Uriz-Otano F, Iniesta R, Gil-Guerrero L. Effectiveness of nutritional supplementation on muscle mass in treatment of sarcopenia in old age: a systematic review. J Am Med Dir Assoc. 2013 Jan;14(1):10-7. doi: 10.1016/j.jamda.2012.08.001. Epub 2012 Sep 13.'}, {'pmid': '26857298', 'type': 'BACKGROUND', 'citation': "Lozano-Montoya I, Velez-Diaz-Pallares M, Abraha I, Cherubini A, Soiza RL, O'Mahony D, Montero-Errasquin B, Correa-Perez A, Cruz-Jentoft AJ. Nonpharmacologic Interventions to Prevent Pressure Ulcers in Older Patients: An Overview of Systematic Reviews (The Software ENgine for the Assessment and optimization of drug and non-drug Therapy in Older peRsons [SENATOR] Definition of Optimal Evidence-Based Non-drug Therapies in Older People [ONTOP] Series). J Am Med Dir Assoc. 2016 Apr 1;17(4):370.e1-10. doi: 10.1016/j.jamda.2015.12.091. Epub 2016 Feb 5."}]}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study is that the administration of a high-calorie high-protein oral nutritional supplement twice a day for three months to elderly malnourished in residents in Spain is associated with improved nutritional status, with an increase in body weight of between 5 and 8%, and an improvement in functional status, with low incidence of complication.', 'detailedDescription': 'A prospective, multi centric, observational study. The study is conducted in elderly living in nursing homes in Spain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Malnourished elderly living in nursing homes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 65 years,\n* Living in nursing homes,\n* Malnutrition treated with an hyper-caloric oral nutritional supplementation (1.3 Kcal / ml) and high-protein (protein 20%).\n\nExclusion Criteria:\n\n* Tube feeding (nasogastric or gastrostomy)\n* Terminally ill or palliative treatment and residents with life expectancy of less than 6 months\n* Special nutritional requirements (for example by intestinal malabsorption, short bowel residents or specific nutrition for renal insufficiency).'}, 'identificationModule': {'nctId': 'NCT03083912', 'acronym': 'PROT-e-GER', 'briefTitle': 'Effect of High Protein, High-calorie Oral Nutritional Supplementation in Malnourished Elderly in Nursing Homes.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Viamed Valvanera, Spain'}, 'officialTitle': 'Effect of High Protein, High-calorie Nutritional Supplementation in Malnourished Elderly in Nursing Homes. A Prospective, Observational, Multicentric Study (PROT-e-GER Study)', 'orgStudyIdInfo': {'id': 'PROT-e-GER'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fortimel Complete', 'description': 'All of the residents included receive ONS', 'interventionNames': ['Dietary Supplement: Fortimel Complete']}], 'interventions': [{'name': 'Fortimel Complete', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['ONS'], 'description': 'The residents included receive 2 bottle por day.', 'armGroupLabels': ['Fortimel Complete']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Nuria Fernandez Bodas', 'role': 'STUDY_CHAIR', 'affiliation': 'Nutricia, Inc.'}, {'name': 'Alfonso Cruz Jentoft, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of Geriatric Department, Hospital Universitario Ramón y Cajal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Viamed Valvanera, Spain', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, {'name': 'Hospital General Universitario Gregorio Marañon', 'class': 'OTHER'}, {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MSc, PhD3', 'investigatorFullName': 'Vincenzo Malafarina, MD MSc', 'investigatorAffiliation': 'University of Navarra'}}}}