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NCT Number: NCT01404195

Hyperprotein Nutritional Intervention in Elderly Patients With Hip Fracture and Sarcopenia

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.

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Key information

Conditions

Sarcopenia Atrophy Femoral Fractures Fractures, Bone Frailty Hip Fracture Hip Fractures Hip Injuries Leg Injuries Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Los Manzanos

Logroño, La Rioja, 26140, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ensure Plus Advance

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital Viamed Valvanera, Spain

Other

Collaborators

  • University of Navarra

Registry information

Official study 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.

Acronym: HIPERPROT

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 27, 2011
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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