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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Hospital San Juan de Dios, Spain.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Vincenzo Malafarina, MD, Hospital San Juan de Dios, Spain
ClinicalTrials.gov Identifier:
NCT01404195
First received: July 22, 2011
Last updated: July 24, 2012
Last verified: July 2012
  Purpose
  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; 6) to assess reduction in fragility indices.

  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 Intervention
Sarcopenia
Hip Fracture
Dietary Supplement: Ensure Plus Advance

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hyperprotein Nutritional Intervention in Elderly Patients With Hip Fracture and Sarcopenia. A Prospective, Randomized, Double-blind Clinical Study HIPERPROT-GER STUDY

Resource links provided by NLM:


Further study details as provided by Hospital San Juan de Dios, Spain:

Primary Outcome Measures:
  • Change from baseline in Barthel index [ Time Frame: On admission to hospital and at discharge. ] [ Designated as safety issue: No ]
    functional improvement after nutritional intervention in sarcopenic patients with hip fracture, as measured using Barthel index.


Secondary Outcome Measures:
  • Change from baseline in bioelectrical impedance analysis [ Time Frame: On admission to hospital and at discharge. ] [ Designated as safety issue: No ]
    Show muscle mass improvement

  • 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. ] [ Designated as safety issue: No ]
    Show an increased strength

  • Death for any cause [ Time Frame: During admission ] [ Designated as safety issue: No ]
    assess mortality and morbidity

  • 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 ] [ Designated as safety issue: No ]
    To show the relationship between inflammatory indices and sarcopenia

  • Prevalence of sarcopenia [ Time Frame: hospital admission ] [ Designated as safety issue: No ]
    To determine the prevalence of sarcopenia in elderly patients hospitalized for hip fracture.


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Ensure Plus Advance
No Intervention: Control
without supplementation

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404195

Contacts
Contact: Vincenzo Malafarina, MD +34948231800 vmalafarina@gmail.com
Contact: Lucía Gil-Guerrero, MD, PhD +34948231800 luciagil5@yahoo.es

Locations
Spain
Hospital San Juan de Dios Recruiting
Pamplona, Navarra, Spain, 31008
Contact: Vincenzo Malafarina, MD    +34948231800    vmalafarina@gmail.com   
Contact: Lucía Gil-Guerrero, MD, PhD    +34948231800    luciagil5@yahoo.es   
Principal Investigator: Vincenzo Malafarina, MD         
Sub-Investigator: Lucía Gil-Guerrero, MD, PhD         
Sub-Investigator: Francisco Úriz-Otano, MD         
Sub-Investigator: Raquel Iniesta-Benedicto, PhD         
Sponsors and Collaborators
Hospital San Juan de Dios, Spain
Investigators
Principal Investigator: Vincenzo Malafarina, MD Hospital San Juan de Dios - Pamplona - Spain
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vincenzo Malafarina, MD, MD, Hospital San Juan de Dios, Spain
ClinicalTrials.gov Identifier: NCT01404195     History of Changes
Other Study ID Numbers: HSJD-Pam-01, HSJDPAM01SARCOP2011
Study First Received: July 22, 2011
Last Updated: July 24, 2012
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital San Juan de Dios, Spain:
Nutritional supplement
CaHMB
Barthel index
Frailty

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Sarcopenia
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014