Effects of a Supplement Enriched in Hydroxymethylbutyrate and Vitamin D on Muscle Strength in Hip Fracture
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01850251|
Recruitment Status : Terminated (Recruiting problems.)
First Posted : May 9, 2013
Last Update Posted : August 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hip Fractures||Dietary Supplement: Supplement with HMB and vitamin D Dietary Supplement: Standard nutritional supplement||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||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.|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
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 Name: 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 Name: Ensure Plus High Protein
- Change in bilateral knee extension test as a measure of isometric muscle strength. [ Time Frame: Baseline and 8 weeks ]Changes from baseline in the knee extension test at 8 weeks will be conducted using a dynamometer.
- Change in the Timed Up & Go test as a measure of function. [ Time Frame: Baseline and 8 weeks ]Changes from baseline in the Timed Up & Go functional test at 8 weeks.
- Quality of life [ Time Frame: Baseline and 8 weeks ]Change from baseline in quality of life at 8 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850251
|Hospital Clinic de Barcelona|
|Barcelona, Catalonia, Spain, 08036|
|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|