A Phase 4 interventional study of Supplement with HMB and vitamin D and Standard nutritional supplement in Hip Fractures, sponsored by Hospital Clinic of Barcelona. Terminated at 1 site in Spain. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2015-08-19.
Sponsored by Hospital Clinic of Barcelona · Phase 4, Interventional, and Supportive care
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.
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.
848 studies on the registry are indexed under Hip Fractures; 160 are open to participants now.
This study's enrollment of 2 is below the median of 90 across 540 interventional studies indexed under Hip Fractures.
Browse Hip Fractures studies →Hospital Clinic of Barcelona is the lead sponsor of 326 studies on the registry; 54 are open to participants now.
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Exclusion Criteria:
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
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 enriched with hydroxymethylbutyrate and vitamin D.
Also known as: Ensure Plus Advance
High protein, high calorie nutritional supplement.
Also known as: Ensure Plus High Protein
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.
Time frame: Baseline and 8 weeks
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.
Time frame: Baseline and 8 weeks
Quality of life
Change from baseline in quality of life at 8 weeks
Time frame: Baseline and 8 weeks
The record gives a start of Jun 2013, a primary completion of Mar 2015 and a completion of Mar 2015. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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