Effect of High Protein, High-calorie Oral Nutritional Supplementation in Malnourished Elderly in Nursing Homes.
NCT ID: NCT03083912
Last Updated: 2017-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
291 participants
OBSERVATIONAL
2016-03-31
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Fortimel Complete
All of the residents included receive ONS
Fortimel Complete
The residents included receive 2 bottle por day.
Interventions
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Fortimel Complete
The residents included receive 2 bottle por day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Living in nursing homes,
* Malnutrition treated with an hyper-caloric oral nutritional supplementation (1.3 Kcal / ml) and high-protein (protein 20%).
Exclusion Criteria
* Terminally ill or palliative treatment and residents with life expectancy of less than 6 months
* Special nutritional requirements (for example by intestinal malabsorption, short bowel residents or specific nutrition for renal insufficiency).
65 Years
ALL
No
Sponsors
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Hospital Universitario Ramon y Cajal
OTHER
Hospital General Universitario Gregorio Marañon
OTHER
Hospital Clinic of Barcelona
OTHER
Hospital Viamed Valvanera, Spain
OTHER
Responsible Party
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Vincenzo Malafarina, MD MSc
MD, MSc, PhD3
Principal Investigators
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Nuria Fernandez Bodas
Role: STUDY_CHAIR
Nutricia, Inc.
Alfonso Cruz Jentoft, MD PhD
Role: STUDY_DIRECTOR
Head of Geriatric Department, Hospital Universitario Ramón y Cajal
Locations
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Hospital Universitario Ramón y Cajal
Madrid, , Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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PROT-e-GER
Identifier Type: -
Identifier Source: org_study_id