Effects of a Supplement Enriched in Hydroxymethylbutyrate and Vitamin D on Muscle Strength in Hip Fracture

Randomized Controlled, Pilot Study to Assess the Effect of a High Protein and Calorie Nutritional Supplementation Enriched Hydroxymethylbutyrate and Vitamin D on Muscle Strength and Function in Patients With Hip Fracture.

The purpose of this study is to determine whether a nutritional supplement high in protein and energy, and enriched with hydroxymethylbutyrate (HMB) and vitamin D is more effective than a standard nutritional supplement high in protein and energy in improving muscle strength in elderly patients with hip fracture.

Study Overview

• Status: Terminated
• Conditions: Hip Fractures
• Intervention / Treatment: Dietary supplement: Supplement with HMB and vitamin D; Dietary supplement: Standard nutritional supplement

Detailed Description

Hip fractures are the cause of substantial morbidity and mortality in elderly people. Nine months after hip fracture, patients still have a poorer quality of life compared to control subjects matched for age and sex.

After a hip fracture, many patients fail to return to their homes and their previous state of mobility. Acute hospital costs generated by this condition are substantial, although the costs in rehabilitation and special care in long-term community are even greater.

Patients with hip fracture are most likely to be frail elderly, and they are usually malnourished when the fracture occurs. Moreover, physiological aging is accompanied by functional losses and changes in the various organs and systems, including the musculoskeletal system, in which there is a progressive reduction of muscle mass, called sarcopenia. Approximately 30% of muscle mass is lost between the fifth and eighth decades of life and the percentage of muscle loss can reach 15% per decade after 70 years of age. Having established a correlation between the loss of muscle mass and loss of strength, sarcopenia has been associated with a risk of functional disability twice in men and thrice in women.

Hydroxymethylbutyrate (HMB) is a leucine metabolite produced in small quantities (0.3-0.4 g/d). Leucine effects on muscle metabolism appear to be due, in part, to HMB. In vitro experiments have observed that HMB attenuates proteolysis processes through the inhibition of various catabolic pathways and could stimulate protein synthesis. There are some evidences that administration of HMB in the elderly results in increases in muscle strength and functionality enhancements, compared to a control group.

In elderly people, low levels of vitamin D have been associated, among others, to decreased muscle strength, falls and fractures. The elderly have an increased risk of developing vitamin D deficiency due to less sun exposure, a decrease in the absorption and changes in the metabolism of this vitamin. Because muscle weakness is a clinical feature of vitamin D deficiency, it has been postulated that its deficiency could precipitate and increase muscle weakness and functional decline in older people.

Therefore, the study raises the possibility that an intervention consisting of a high protein, high calorie oral nutritional supplement enriched with HMB and vitamin D is more effective than a standard high protein, high calorie oral nutritional supplement in improving muscle strength.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • Hospital Clinic De Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients over 65 years of age after hip fracture surgery.
• Ability to walk before fracture.

Exclusion Criteria:

• Chronic renal failure, defined as a glomerular filtration rate less than 60 mL/min/1.73 m2, or serum creatinine of 0.9 mg/dL in women or 1.2 mg/dL in men.
• Following a diet with protein restriction.
• Need for enteral or parenteral nutrition.
• Need for medication with orexigenic or anabolic effect, or long-term corticosteroids.
• Active neoplastic disease.
• Cognitive impairment or major psychiatric disorder.
• Lack of signed informed consent.
• Any patient with inability to comply with treatment or not appropriate according to the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supplement with HMB and vitamin D; Oral administration of 440 mL (2 bottles) of nutritional supplement with HMB and vitamin D each day during 8 weeks.	Dietary supplement: Supplement with HMB and vitamin D; High protein, high calorie nutritional supplement enriched with hydroxymethylbutyrate and vitamin D.; Other Names: Ensure Plus Advance
Active Comparator: Standard nutritional supplement; Oral administration of 440 mL (2 bottles) of standard nutritional supplement each day during 8 weeks.	Dietary supplement: Standard nutritional supplement; High protein, high calorie nutritional supplement.; Other Names: Ensure Plus High Protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in bilateral knee extension test as a measure of isometric muscle strength.	Changes from baseline in the knee extension test at 8 weeks will be conducted using a dynamometer.	Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Timed Up & Go test as a measure of function.	Changes from baseline in the Timed Up & Go functional test at 8 weeks.	Baseline and 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Change from baseline in quality of life at 8 weeks	Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Abbott
• Investigators: Principal Investigator: Maria T Forga, MD, Hospital Clinic of Barcelona; Study Chair: Joan Trabal, RD, MS, Hospital Clinic of Barcelona; Study Chair: Pere Leyes, MD, Hospital Clinic of Barcelona; Study Chair: Salvi Prat, MD, PhD, Hospital Clinic of Barcelona; Study Chair: Margarita Navarro, MD, Hospital Clinic of Barcelona

Publications and helpful links

General Publications

• Fuller JC Jr, Baier S, Flakoll P, Nissen SL, Abumrad NN, Rathmacher JA. Vitamin D status affects strength gains in older adults supplemented with a combination of beta-hydroxy-beta-methylbutyrate, arginine, and lysine: a cohort study. JPEN J Parenter Enteral Nutr. 2011 Nov;35(6):757-62. doi: 10.1177/0148607111413903. Epub 2011 Aug 1.

Helpful Links

• Click here for more information about hip fractures.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: May 3, 2013
• First Submitted That Met QC Criteria: May 7, 2013
• First Posted (Estimate): May 9, 2013

Study Record Updates

• Last Update Posted (Estimate): August 19, 2015
• Last Update Submitted That Met QC Criteria: August 18, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Ageing; Sarcopenia; Function; Hip fractures
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: ORTOHMB-13