Hip FracturesPhase 4NCT01850251
Effects of a Supplement Enriched in Hydroxymethylbutyrate and Vitamin D on Muscle Strength in Hip Fracture
A Phase 4 study testing Supplement with HMB and vitamin D and Standard nutritional supplement in people with Hip Fractures, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Supplement with HMB and vitamin D and Standard nutritional supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2013to Mar 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients over 65 years of age after hip fracture surgery.
- Ability to walk before fracture.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Being tested
- Supplement with HMB and vitamin D, Standard nutritional supplement
- Keywords
- Hip fractures, Ageing, Sarcopenia, Function
- Medical subject headings
- Hip Fractures, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplement with HMB and vitamin DDietary supplement
Also called Ensure Plus Advance
High protein, high calorie nutritional supplement enriched with hydroxymethylbutyrate and vitamin D.
Standard nutritional supplementDietary supplement
Also called Ensure Plus High Protein
High protein, high calorie nutritional supplement.
| Study group | Role | What they receive |
|---|---|---|
| Supplement with HMB and vitamin D | Experimental | Oral administration of 440 mL (2 bottles) of nutritional supplement with HMB and vitamin D each day during 8 weeks. Receives: Dietary Supplement: Supplement with HMB and vitamin D |
| Standard nutritional supplement | Active comparator | Oral administration of 440 mL (2 bottles) of standard nutritional supplement each day during 8 weeks. Receives: Dietary Supplement: Standard nutritional supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 weeks
Secondary outcomes (1)
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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Recruiting problems.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Pere Leyes, Hospital Clinic of Barcelona
- Investigators
- Maria T Forga, MD, Principal investigator, Hospital Clinic of BarcelonaJoan Trabal, RD, MS, Study chair, Hospital Clinic of BarcelonaPere Leyes, MD, Study chair, Hospital Clinic of BarcelonaSalvi Prat, MD, PhD, Study chair, Hospital Clinic of BarcelonaMargarita Navarro, MD, Study chair, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850251
- Sponsor's protocol ID
- ORTOHMB-13
- Status last verified
- Aug 2015
- First submitted
- 3 May 2013
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21807930
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01850251
- Acronym / sponsor ID
- ORTOHMB-13
- Conditions
- Hip Fractures
- Keywords
- Hip fractures, Ageing, Sarcopenia, Function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting problems.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Jun 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 9 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement with HMB and vitamin D | Experimental | Dietary Supplement: Supplement with HMB and vitamin DOral administration of 440 mL (2 bottles) of nutritional supplement with HMB and vitamin D each day during 8 weeks. |
| Standard nutritional supplement | Active comparator | Dietary Supplement: Standard nutritional supplementOral administration of 440 mL (2 bottles) of standard nutritional supplement each day during 8 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients over 65 years of age after hip fracture surgery.
- Ability to walk before fracture.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplement with HMB and vitamin DAlso: Ensure Plus AdvanceHigh protein, high calorie nutritional supplement enriched with hydroxymethylbutyrate and vitamin D. | Dietary supplement | Supplement with HMB and vitamin D |
| Standard nutritional supplementAlso: Ensure Plus High ProteinHigh protein, high calorie nutritional supplement. | Dietary supplement | Standard nutritional supplement |
Primary outcome
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.
1 secondary outcome
Change in the Timed Up & Go test as a measure of function.
Time frame: Baseline and 8 weeks
Results and safety
The study was stopped early (reason given: Recruiting problems.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
- Background: PubMed 21807930Fuller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria T Forga, MD principal investigator
Hospital Clinic of Barcelona
Joan Trabal, RD, MS study chair
Hospital Clinic of Barcelona
Pere Leyes, MD study chair
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Supplement with HMB and vitamin D and Standard nutritional supplement in people with Hip Fractures, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruiting problems.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bilateral knee extension test as a measure of isometric muscle strength. (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01850251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.