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

NCT ID: NCT01850251

Last Updated: 2015-08-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-03-31

Brief Summary

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.

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.

Conditions

Hip Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Supplement with HMB and vitamin D

Intervention Type: DIETARY_SUPPLEMENT

High protein, high calorie nutritional supplement enriched with hydroxymethylbutyrate and vitamin D.

Standard nutritional supplement

Oral administration of 440 mL (2 bottles) of standard nutritional supplement each day during 8 weeks.

Group Type: ACTIVE_COMPARATOR

Standard nutritional supplement

Intervention Type: DIETARY_SUPPLEMENT

High protein, high calorie nutritional supplement.

Interventions

Supplement with HMB and vitamin D

High protein, high calorie nutritional supplement enriched with hydroxymethylbutyrate and vitamin D.

Intervention Type: DIETARY_SUPPLEMENT

Standard nutritional supplement

High protein, high calorie nutritional supplement.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Ensure Plus Advance; Ensure Plus High Protein

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Pere Leyes

Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria T Forga, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Joan Trabal, RD, MS

Role: STUDY_CHAIR

Hospital Clinic of Barcelona

Pere Leyes, MD

Role: STUDY_CHAIR

Hospital Clinic of Barcelona

Salvi Prat, MD, PhD

Role: STUDY_CHAIR

Hospital Clinic of Barcelona

Margarita Navarro, MD

Role: STUDY_CHAIR

Hospital Clinic of Barcelona

Locations

Hospital Clinic de Barcelona

Barcelona, Catalonia, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 21807930 (View on PubMed)

Other Identifiers

ORTOHMB-13

Identifier Type: -

Identifier Source: org_study_id