Hyperprotein Nutritional Intervention in Elderly Patients With Hip Fracture and Sarcopenia

Sarcopenia Clinical Trial

— HIPERPROT  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404195
• Other study ID #: HVVV-Log-01
• Secondary ID: HSJDPAM01SARCOP2
• Status: Completed
• Phase: N/A
• First received: July 22, 2011
• Last updated: February 4, 2016
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Hospital Viamed Valvanera, Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures
• Sarcopenia

Intervention

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

Locations

Country	Name	City	State
Spain	Clinica Los Manzanos	Logroño	La Rioja

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Viamed Valvanera, Spain	University of Navarra

Country where clinical trial is conducted

Spain, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Barthel index	functional improvement after nutritional intervention in sarcopenic patients with hip fracture, as measured using Barthel index.	On admission to hospital and at discharge.	No
Secondary	Change from baseline in bioelectrical impedance analysis	Show muscle mass improvement	On admission to hospital and at discharge.	No
Secondary	Change from baseline in strength will be measured in the dominant hand using a portable JAMAR dynamometer	Show an increased strength	On admission to hospital and at discharge.	No
Secondary	Death for any cause	assess mortality and morbidity	During admission	No
Secondary	Univariate analysis of the relationship between levels of IL-1, IL-6 and TNF-alpha and values of bioelectrical impedance	To show the relationship between inflammatory indices and sarcopenia	On admission to hospital and at discharge	No
Secondary	Prevalence of sarcopenia	To determine the prevalence of sarcopenia in elderly patients hospitalized for hip fracture.	hospital admission	No