Hyperprotein Nutritional Intervention in Elderly Patients With Hip Fracture and Sarcopenia

NCT01404195 | Completed DMC

• 3 other identifiers: HVVV-Log-01HSJDPAM01SARCOP2011ViamedValvaSarcoHF
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 3.OBJECTIVES Primary objective is to assess functional improvement after nutritional intervention in sarcopenic patients with hip fracture, as measured using Barthel index.
4. 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.

Conditions

Sarcopenia; Hip Fracture

Keywords

Nutritional supplement; CaHMB; Barthel index; Frailty

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (5)

• Change from baseline in bioelectrical impedance analysis

  On admission to hospital and at discharge.

• Change from baseline in strength will be measured in the dominant hand using a portable JAMAR dynamometer

  On admission to hospital and at discharge.

• Death for any cause

  During admission

• Univariate analysis of the relationship between levels of IL-1, IL-6 and TNF-alpha and values of bioelectrical impedance

  On admission to hospital and at discharge

• Prevalence of sarcopenia

  hospital admission

Study Arms (2)

Ensure Plus Advance, Supplement

EXPERIMENTAL

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

Control

NO INTERVENTION

without supplementation

Interventions

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

Ensure Plus Advance, Supplement

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Viamed Valvanera, Spain: lead
• University of Navarra: collaborator

Study Sites (1)

Clinica Los Manzanos

Logroño, La Rioja, 26140, Spain

Location

Related Publications (25)

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MeSH Terms

Conditions

Sarcopenia; Hip Fractures; Frailty

Condition Hierarchy (Ancestors)

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

Study Officials

• Vincenzo Malafarina, MD Msc

  Clinica Los Manzanos, Lardero, Spain

  PRINCIPAL INVESTIGATOR

• M Angeles Zulet, PhD

  University of Navarra

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MSc

Study Record Dates

• First Submitted: July 22, 2011
• First Posted: July 27, 2011
• Study Start: January 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 5, 2016

Record last verified: 2016-02

Locations

ES (1)