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

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ClinicalTrials.gov Identifier: NCT01404195
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : February 5, 2016
Sponsor:
Collaborator:
University of Navarra
Information provided by (Responsible Party):
Vincenzo Malafarina, MD MSc, Hospital Viamed Valvanera, Spain

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Sarcopenia Hip Fracture Dietary Supplement: Ensure Plus Advance Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : January 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change from baseline in bioelectrical impedance analysis [ Time Frame: On admission to hospital and at discharge. ]
    Show muscle mass improvement

  2. 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

  3. Death for any cause [ Time Frame: During admission ]
    assess mortality and morbidity

  4. 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

  5. Prevalence of sarcopenia [ Time Frame: hospital admission ]
    To determine the prevalence of sarcopenia in elderly patients hospitalized for hip fracture.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404195


Locations
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Spain
Clinica Los Manzanos
Logroño, La Rioja, Spain, 26140
Sponsors and Collaborators
Hospital Viamed Valvanera, Spain
University of Navarra
Investigators
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Principal Investigator: Vincenzo Malafarina, MD Msc Clinica Los Manzanos, Lardero, Spain
Study Chair: M Angeles Zulet, PhD University of Navarra
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Vincenzo Malafarina, MD MSc, MD MSc, Hospital Viamed Valvanera, Spain
ClinicalTrials.gov Identifier: NCT01404195    
Other Study ID Numbers: HVVV-Log-01
HSJDPAM01SARCOP2011 ( Other Identifier: Hospital San Juan de Dios )
ViamedValvaSarcoHF ( Other Identifier: Hospital Viamed Valvanera )
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016
Keywords provided by Vincenzo Malafarina, MD MSc, Hospital Viamed Valvanera, Spain:
Nutritional supplement
CaHMB
Barthel index
Frailty
Additional relevant MeSH terms:
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Sarcopenia
Fractures, Bone
Hip Fractures
Wounds and Injuries
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
 Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Femoral Fractures
Hip Injuries
Leg Injuries