Age Related Muscle LossHMBNCT02118181
Assessment of Physical Performance With A Supplementation Containing HMB in a Sample of Old Women in Good Health
A study testing HMB in people with Age Related Muscle Loss, run by University of Padova at 1 site in Italy.
Trial summary
The purpose of this study is to determine whether a supplementation containing β-Hydroxy-β-methylbutyrate is effective in the treatment of age-related muscle loss in a group of older women compared to a non interventional group Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Age Related Muscle Loss
- What is being tested?
- HMB
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2014to Jun 2014
- Phase
- Interventional
- 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
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- People over 65 years, not residents in nursing home, in good health
- Mini Mental State Examination (corrected for scholarity) more than 23
Who cannot join
- Previous oral supplementation with proteins or minerals
- important co-mordidities, such renal or hepatic failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Oral Supplementation of Proteins and β-hydroxy-β-methyl Butyrate (HMB) in a Sample of Older Women in Good Health
The purpose of this study is to determine whether a supplementation containing β-Hydroxy-β-methylbutyrate is effective in the treatment of age-related muscle loss in a group of older women compared to a non interventional group
- Conditions
- Age Related Muscle Loss
- Being tested
- HMB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMBDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| HMB | Experimental | Group taking oral supplementation with Beta-hydroxy-beta-methylbutyrate Receives: Dietary Supplement: HMB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Short Physical Performance Battery
Measured: Baseline and after 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2014
- Study completionJun 2014
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 Age Related Muscle LossStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Sergi, University of Padova
- Investigators
- Giuseppe Sergi, MD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118181
- Sponsor's protocol ID
- Not Avalaible
- Acronym
- HMB
- Status last verified
- Apr 2014
- First submitted
- 16 Apr 2014
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Berton L, Bano G, Carraro S, Veronese N, Pizzato S, Bolzetta F, De Rui M, Valmorbida E, De Ronch I, Perissinotto E, Coin A, Manzato E, Sergi G. Effect of Oral Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation on Physical Performance in Healthy Old Women Over 65 Years: An Open Label Randomized Controlled Trial. PLoS One. 2015 Nov 3;10(11):e0141757. doi: 10.1371/journal.pone.0141757. eCollection 2015.
PubMed 26529601
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Oral Supplementation of Proteins and β-hydroxy-β-methyl Butyrate (HMB) in a Sample of Older Women in Good Health
- ClinicalTrials.gov ID
- NCT02118181
- Acronym / sponsor ID
- HMB / Not Avalaible
- Conditions
- Age Related Muscle Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 21 Apr 2014 (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 supplementation containing β-Hydroxy-β-methylbutyrate is effective in the treatment of age-related muscle loss in a group of older women compared to a non interventional group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| HMB | Experimental | Dietary Supplement: HMBGroup taking oral supplementation with Beta-hydroxy-beta-methylbutyrate |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- People over 65 years, not residents in nursing home, in good health
- Mini Mental State Examination (corrected for scholarity) more than 23
Key exclusion criteria (2 listed)
- Previous oral supplementation with proteins or minerals
- important co-mordidities, such renal or hepatic failure
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 |
|---|---|---|
| HMB | Dietary supplement | HMB |
Primary outcome
Change in Short Physical Performance Battery
Time frame: Baseline and after 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Derived from this study: PubMed 26529601Berton L, Bano G, Carraro S, Veronese N, Pizzato S, Bolzetta F, De Rui M, Valmorbida E, De Ronch I, Perissinotto E, Coin A, Manzato E, Sergi G. Effect of Oral Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation on Physical Performance in Healthy Old Women Over 65 Years: An Open Label Randomized Controlled Trial. PLoS One. 2015 Nov 3;10(11):e0141757. doi: 10.1371/journal.pone.0141757. eCollection 2015.
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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.
Giuseppe Sergi, MD principal investigator
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMB in people with Age Related Muscle Loss, run by University of Padova at 1 site in Italy.
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 2 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: finished, as of the sponsor's last update on 3 Dec 2014. 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 Italy. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Short Physical Performance Battery (time frame: Baseline and after 2 months). 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 NCT02118181, 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 3 Dec 2014.