Hyperprotein Nutritional Intervention in Elderly Patients With Hip Fracture and Sarcopenia (HIPERPROT)

February 4, 2016 updated by: Vincenzo Malafarina, MD MSc, Hospital Viamed Valvanera, Spain

High-protein Nutritional Intervention Based on β-hydroxy-β-methylbutirate, Vitamin D3 and Calcium on Obese and Lean Aged Patients With Hip Fractures and Sarcopenia. The HIPERPROT-GER Study.

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

INTRODUCTION Sarcopenia is the loss of muscle mass and function associated to age. Rosemberg first spoke of sarcopenia in 1989. A progressive loss of muscle mass occurs from approximately 40 years of age. This loss is estimated at about 8% by decade until the age of 70 years, after which the loss increases to 15% by decade. Healthcare costs attributable to sarcopenia in the United States (US) in 2000 were estimated to be 18.5 billion dollars.

It would be natural to assume a direct relationship between muscle mass and strength, but loss of muscle mass is not the main mechanism for loss of strength.

Proximal femur (hip) fracture is a substantial cause of morbidity and mortality in the elderly. One-year mortality after a hip fracture ranges from 12% and 37%, with an 11% incidence during the first few months.

Twenty-five percent of elderly patients with hip fracture require institutionalization, at least temporary, and only 40% fully recover their pre-fracture functional status.

Nutritional therapy, particularly beta-hydroxy-beta-methylbutyrate (HMB), a metabolite of the essential amino acid, leucine, has aroused great expectations. All prior studies about nutritional supplementation with HMB have shown an improved muscle metabolism, decreased protein degradation, and a significant increase in fat-free mass in both young and elderly people.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • La Rioja
      • Logroño, La Rioja, Spain, 26140
        • Clinica Los Manzanos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 65 years or older
  • Diagnosis of traumatic hip fracture
  • Patients admitted for rehabilitation
  • Patients signing informed consent.

Exclusion Criteria:

  • Stage 4 renal failure
  • Child C stage hepatic insufficiency
  • Barthel index < 20 in the six months prior to admission
  • Dysphagia for liquids
  • Active oncological disease who are receiving treatment
  • Severe clinical conditions compromising and threatening their lives
  • Morbid obesity (BMI > 40)
  • BMI < 21 kg/m2
  • Albumin levels < 2.1 g/dL
  • MNA < 11
  • Charlson index ≥ 6
  • diabetes mellitus
  • Patients not doing rehabilitation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ensure Plus Advance, Supplement
Participating patients will be dispensed two bottles daily, one at breakfast and one in the evening, seven days a week.
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
NO_INTERVENTION: Control
without supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Barthel index
Time Frame: On admission to hospital and at discharge.
functional improvement after nutritional intervention in sarcopenic patients with hip fracture, as measured using Barthel index.
On admission to hospital and at discharge.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in bioelectrical impedance analysis
Time Frame: On admission to hospital and at discharge.
Show muscle mass improvement
On admission to hospital and at discharge.
Change from baseline in strength will be measured in the dominant hand using a portable JAMAR dynamometer
Time Frame: On admission to hospital and at discharge.
Show an increased strength
On admission to hospital and at discharge.
Death for any cause
Time Frame: During admission
assess mortality and morbidity
During admission
Univariate analysis of the relationship between levels of IL-1, IL-6 and TNF-alpha and values of bioelectrical impedance
Time Frame: On admission to hospital and at discharge
To show the relationship between inflammatory indices and sarcopenia
On admission to hospital and at discharge
Prevalence of sarcopenia
Time Frame: hospital admission
To determine the prevalence of sarcopenia in elderly patients hospitalized for hip fracture.
hospital admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Viamed Valvanera, Spain

Collaborators

University of Navarra

Investigators

  • Study Chair: M Angeles Zulet, PhD, University of Navarra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

July 22, 2011

First Submitted That Met QC Criteria

July 26, 2011

First Posted (ESTIMATE)

July 27, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 5, 2016

Last Update Submitted That Met QC Criteria

February 4, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HVVV-Log-01
  • HSJDPAM01SARCOP2011 (OTHER: Hospital San Juan de Dios)
  • ViamedValvaSarcoHF (OTHER: Hospital Viamed Valvanera)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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