Clinical trial NCT03083912: Effect of High Protein, High-calorie Oral Nutritional Supplementation in Malnourished Elderly in Nursing Homes.
Official title: Effect of High Protein, High-calorie Nutritional Supplementation in Malnourished Elderly in Nursing Homes. A Prospective, Observational, Multicentric Study (PROT-e-GER Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Other Malnutrition
Keywords: Malnutrition
Disability
Oral Nutritional Supplementation
Lead sponsor: Hospital Viamed Valvanera, Spain
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Ramon y Cajal
name: Hospital General Universitario Gregorio Marañon
name: Hospital Clinic of Barcelona
First posted: 2017-03-20
Enrollment: 291
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Malnourished elderly living in nursing homes

Brief summary: 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.

Detailed description: A prospective, multi centric, observational study. The study is conducted in elderly living in nursing homes in Spain.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 65 years,
* Living in nursing homes,
* Malnutrition treated with an hyper-caloric oral nutritional supplementation (1.3 Kcal / ml) and high-protein (protein 20%).

Exclusion Criteria:

* Tube feeding (nasogastric or gastrostomy)
* 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).

Primary outcomes:
measure: Improve weight
timeFrame: 3 months
Secondary outcomes:
measure: SPPB scale
timeFrame: 3 months
measure: Barthel index
timeFrame: 3 months
Other outcomes:
measure: Number of drinking bottles during the study.
timeFrame: 3 months
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
Study officials:
affiliation: Nutricia, Inc.
name: Nuria Fernandez Bodas
role: STUDY_CHAIR
affiliation: Head of Geriatric Department, Hospital Universitario Ramón y Cajal
name: Alfonso Cruz Jentoft, MD PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.