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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Hospital Clinic of Barcelona
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Pere Leyes, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01850251
First received: May 3, 2013
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Hip Fractures
Dietary Supplement: Supplement with HMB and vitamin D
Dietary Supplement: Standard nutritional supplement
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Change in bilateral knee extension test as a measure of isometric muscle strength. [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    Changes from baseline in the knee extension test at 8 weeks will be conducted using a dynamometer.


Secondary Outcome Measures:
  • Change in the Timed Up & Go test as a measure of function. [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    Changes from baseline in the Timed Up & Go functional test at 8 weeks.


Other Outcome Measures:
  • Quality of life [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    Change from baseline in quality of life at 8 weeks


Estimated Enrollment: 50
Study Start Date: June 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01850251

Contacts
Contact: Joan Trabal, RD, MS +34932275400 ext 3424 jtrabal@clinic.cat

Locations
Spain
Hospital Clinic de Barcelona Recruiting
Barcelona, Catalonia, Spain, 08036
Contact: Joan Trabal, RD, MS    +34932275400 ext 3424    jtrabal@clinic.cat   
Principal Investigator: Maria T Forga, MD         
Sub-Investigator: Joan Trabal, RD, MS         
Sponsors and Collaborators
Hospital Clinic of Barcelona
Abbott
Investigators
Principal Investigator: Maria T Forga, MD Hospital Clinic de Barcelona
Study Chair: Joan Trabal, RD, MS Hospital Clinic de Barcelona
Study Chair: Pere Leyes, MD Hospital Clinic de Barcelona
Study Chair: Salvi Prat, MD, PhD Hospital Clinic de Barcelona
Study Chair: Margarita Navarro, MD Hospital Clinic de Barcelona
  More Information

Additional Information:
Publications:
Responsible Party: Pere Leyes, Specialist, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01850251     History of Changes
Other Study ID Numbers: ORTOHMB-13
Study First Received: May 3, 2013
Last Updated: June 19, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Clinic of Barcelona:
Hip fractures
Ageing
Sarcopenia
Function

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 15, 2014