SarcopeniaPhase 2/3NCT02401113
Effect of Ursolic Acid of Loquat Extract on Function of Muscle
A Phase 2/3 study testing UA group in people with Sarcopenia, run by Pusan National University Hospital.
Trial summary
This randomized, placebo-controlled, double-blind study was designed to investigate the efficacy and tolerability of Ursolic Acid of Loquat Extract for treatment of muscle function improvement with relatively health adults. 54 subjects received 500 mg of Loquat Extract per day or a placebo for 12 weeks. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- UA group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Oct 2015
- Phase
- Phase 2/3
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 18.5-30KG/M2
Who cannot join
- > SERUM creatinine 1.2mg/dL
- > AST or ALT 60IU/L
- DM Patients
About this study
Official title: Effect of Ursolic Acid of Loquat Extract on Function of Muscle in Human
This randomized, placebo-controlled, double-blind study was designed to investigate the efficacy and tolerability of Ursolic Acid of Loquat Extract for treatment of muscle function improvement with relatively health adults. 54 subjects received 500 mg of Loquat Extract per day or a placebo for 12 weeks.
Read the detailed description
This randomized, placebo-controlled, double-blind study was designed to investigate the efficacy and tolerability of Ursolic Acid of Loquat Extract for treatment of muscle function improvement with relatively health adults. 54 subjects received 500 mg of Loquat Extract per day or a placebo for 12 weeks. Change over time in muscle fuction was evaluated by four outcomes: assessment of appendicular skeletal mass using DEXA (dual energy X-ray absorptiometry); quadriceps muscle power by Biodex; hand grib power; and Short Physical Performance Battery, SPPB.
- Conditions
- Sarcopenia
- Being tested
- UA group
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UA groupDietary supplement
Ursolic Acid of Loquat Extract, 500mg/ day during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| UA group | Experimental | UA group who takes Ursolic acid of Loquat Extract , 500 mg/ day during 12 weeks for treatment of muscle function improvement with relatively health adults Receives: Dietary Supplement: UA group |
| placebo group | Placebo comparator | placebo group who takes a placebo, 500 mg/day for 12 weeks Receives: Dietary Supplement: UA group |
What is being measured
The primary outcome is the main question the study is designed to answer.
quadriceps muscle function
Measured: 12weeks
Secondary outcomes (2)
ASM(appendicular skeletal mass) marker
Measured: 12weeks
Short Physical Performance Battery, SPPB
Measured: 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startNov 2014
- Primary completionFeb 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Yeoup Lee, Pusan National University Hospital
- Investigators
- SANG YEOUP Lee, Pf., Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401113
- Sponsor's protocol ID
- UrsolicAcid
- Status last verified
- Oct 2015
- First submitted
- 24 Mar 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Prissadova N, Bozov P, Marinkov K, Badakov H, Kristev A. Effects of ursolic acid on contractile activity of gastric smooth muscles. Nat Prod Commun. 2015 Apr;10(4):565-6.
PubMed 25973477Cho YH, Lee SY, Kim CM, Kim ND, Choe S, Lee CH, Shin JH. Effect of Loquat Leaf Extract on Muscle Strength, Muscle Mass, and Muscle Function in Healthy Adults: A Randomized, Double-Blinded, and Placebo-Controlled Trial. Evid Based Complement Alternat Med. 2016;2016:4301621. doi: 10.1155/2016/4301621. Epub 2016 Nov 24.
PubMed 27999607
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ursolic Acid of Loquat Extract on Function of Muscle in Human
- ClinicalTrials.gov ID
- NCT02401113
- Acronym / sponsor ID
- UrsolicAcid
- Conditions
- Sarcopenia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 27 Mar 2015 (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.
This randomized, placebo-controlled, double-blind study was designed to investigate the efficacy and tolerability of Ursolic Acid of Loquat Extract for treatment of muscle function improvement with relatively health adults. 54 subjects received 500 mg of Loquat Extract per day or a placebo for 12 weeks.
Detailed description
This randomized, placebo-controlled, double-blind study was designed to investigate the efficacy and tolerability of Ursolic Acid of Loquat Extract for treatment of muscle function improvement with relatively health adults. 54 subjects received 500 mg of Loquat Extract per day or a placebo for 12 weeks. Change over time in muscle fuction was evaluated by four outcomes: assessment of appendicular skeletal mass using DEXA (dual energy X-ray absorptiometry); quadriceps muscle power by Biodex; hand grib power; and Short Physical Performance Battery, SPPB.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UA group | Experimental | Dietary Supplement: UA groupUA group who takes Ursolic acid of Loquat Extract , 500 mg/ day during 12 weeks for treatment of muscle function improvement with relatively health adults |
| placebo group | Placebo comparator | Dietary Supplement: UA groupplacebo group who takes a placebo, 500 mg/day for 12 weeks |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI 18.5-30KG/M2
Key exclusion criteria (3 listed)
- > SERUM creatinine 1.2mg/dL
- > AST or ALT 60IU/L
- DM Patients
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 |
|---|---|---|
| UA groupUrsolic Acid of Loquat Extract, 500mg/ day during 12 weeks | Dietary supplement | UA group, placebo group |
Primary outcome
quadriceps muscle function
Time frame: 12weeks
2 secondary outcomes
ASM(appendicular skeletal mass) marker
Time frame: 12weeks
Short Physical Performance Battery, SPPB
Time frame: 12weeks
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 Nov 2015.
- Results publication: PubMed 25973477Prissadova N, Bozov P, Marinkov K, Badakov H, Kristev A. Effects of ursolic acid on contractile activity of gastric smooth muscles. Nat Prod Commun. 2015 Apr;10(4):565-6.
- Derived from this study: PubMed 27999607Cho YH, Lee SY, Kim CM, Kim ND, Choe S, Lee CH, Shin JH. Effect of Loquat Leaf Extract on Muscle Strength, Muscle Mass, and Muscle Function in Healthy Adults: A Randomized, Double-Blinded, and Placebo-Controlled Trial. Evid Based Complement Alternat Med. 2016;2016:4301621. doi: 10.1155/2016/4301621. Epub 2016 Nov 24.
Related trials for Sarcopenia
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
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.
SANG YEOUP Lee, Pf. principal investigator
Pusan National University Yangsan Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing UA group in people with Sarcopenia, run by Pusan National University Hospital.
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 1 inclusion and 3 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 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
quadriceps muscle function (time frame: 12weeks). 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 NCT02401113, which also lists 2 linked publications.
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 Nov 2015; AzTrials last refreshed its copy on 7 Nov 2026.