Effect of High Protein, High-calorie Oral Nutritional Supplementation in Malnourished Elderly in Nursing Homes.

NCT03083912 | Completed

• 1 other identifier: PROT-e-GER
• Study Type: observational
• Target: 291
• Locations: 1 country
• Sites: 1

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.

Conditions

Other Malnutrition

Keywords

Malnutrition; Disability; Oral Nutritional Supplementation

Outcome Measures

Primary Outcomes (1)

• Improve weight

  Difference between the weight of the residents at the beginning and at the end of the study

  3 months

Secondary Outcomes (2)

• SPPB scale

  3 months

• Barthel index

  3 months

Other Outcomes (1)

• Number of drinking bottles during the study.

  3 months

Study Arms (1)

Fortimel Complete

All of the residents included receive ONS

Dietary Supplement: Fortimel Complete

Interventions

Fortimel Complete DIETARY_SUPPLEMENT

The residents included receive 2 bottle por day.

Also known as: ONS

Fortimel Complete

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Malnourished elderly living in nursing homes

You may qualify if:

• 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%).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital Viamed Valvanera, Spain: lead
• Hospital Universitario Ramon y Cajal: collaborator
• Hospital General Universitario Gregorio Marañon: collaborator
• Hospital Clinic of Barcelona: collaborator

Study Sites (1)

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Related Publications (6)

• 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: 23415063 BACKGROUND

• 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: 24246053 BACKGROUND

• 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: 27068239 BACKGROUND

• 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: 26025067 BACKGROUND

• 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: 22980996 BACKGROUND

• 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.

  PMID: 26857298 BACKGROUND

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Nuria Fernandez Bodas

  Nutricia, Inc.

  STUDY CHAIR

• Alfonso Cruz Jentoft, MD PhD

  Head of Geriatric Department, Hospital Universitario Ramón y Cajal

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, PhD3

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: March 20, 2017
• Study Start: March 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 28, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)