Hyperprotein Nutritional Intervention in Elderly Patients With Hip Fracture and Sarcopenia

Summary

1. RATIONALE The unique characteristic of our study lies in the attempt to reverse the functional impairment experienced by sarcopenic patients with hip fracture using nutritional intervention. What makes this study different from prior studies is that it will be conducted in a hospital setting, unlike most prior studies, which were conducted in a community setting. The association between muscle mass and strength, inflammatory indices, and functional impairment versus dependence and fragility will also be measured.
2. HYPOTHESIS The hypothesis of our study is that nutritional intervention enriched in metabolites of essential amino acids (beta-hydroxy-beta-methylbutyrate) is effective for treating sarcopenia in elderly patients with hip fracture and improves functional level.
3. OBJECTIVES Primary objective is to assess functional improvement after nutritional intervention in sarcopenic patients with hip fracture, as measured using Barthel index.

Secondary objectives will include: 1) to show the relationship between metabolic and inflammatory indices and sarcopenia; 2) to show how sarcopenia and its treatment influence the risk of fall; 3) to show muscle mass improvement; 4) to show increased strength; 5) to assess mortality and morbidity.
4. EXPECTED RESULTS The investigators expect to find that the supplemented group experiences throughout the study period a significant improvement in functional status (Barthel index), an increase in muscle mass, and a reduction in fat mass. An increased strength and a reduction in associated complications (falls) are also expected. The investigators hope to be able to show reductions in inflammatory indices and insulin resistance.

To conclude, by improving muscle strength and mass the investigators expect to find a reduction in the disability and dependence of this population group.

Conditions

• Sarcopenia
• Hip Fracture

Interventions

DIETARY_SUPPLEMENT

Ensure Plus Advance

Participating patients will be dispensed two small bottles daily, one at breakfast and one in the evening, seven days a week

Sponsors & Collaborators

• University of Navarra

  collaborator OTHER

• Hospital Viamed Valvanera, Spain

  lead OTHER

Principal Investigators

• Vincenzo Malafarina, MD Msc · Clinica Los Manzanos, Lardero, Spain

• M Angeles Zulet, PhD · University of Navarra

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2015-12-31

Completion

2015-12-31

Countries

• Spain

Study Locations