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

Other Malnutrition Clinical Trial

— PROT-e-GER  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03083912
• Other study ID #: PROT-e-GER
• Status: Completed
• Phase: N/A
• First received: October 25, 2016
• Last updated: November 24, 2017
• Start date: March 2016
• Est. completion date: October 2017

Study information

• Verified date: November 2017
• Source: Hospital Viamed Valvanera, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Malnutrition
• Other Malnutrition

Intervention

Dietary Supplement:
• Fortimel Complete
The residents included receive 2 bottle por day.

Locations

Country	Name	City	State
Spain	Hospital Universitario Ramón y Cajal	Madrid

Sponsors (4)

Lead Sponsor	Collaborator
Hospital Viamed Valvanera, Spain	Hospital Clinic of Barcelona, Hospital General Universitario Gregorio Marañon, Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Camina-Martín MA, de Mateo-Silleras B, Malafarina V, Lopez-Mongil R, Niño-Martín V, López-Trigo JA, Redondo-del-Río 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. Review. — View Citation

Lozano-Montoya I, Vélez-Díaz-Pallarés M, Abraha I, Cherubini A, Soiza RL, O'Mahony D, Montero-Errasquín B, Correa-Pérez 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. Review. — View 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. Review. — View 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. Review. — View Citation

Salvà A, Serra-Rexach JA, Artaza I, Formiga F, Rojano I Luque X, Cuesta F, López-Soto A, Masanés 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of drinking bottles during the study.	Evaluate the compliance with the oral nutritional supplementation	3 months
Primary	Improve weight	Difference between the weight of the residents at the beginning and at the end of the study	3 months
Secondary	SPPB scale	Functional status at the end of the study	3 months
Secondary	Barthel index	Ability in Activities of Daily Living at the end of the study	3 months