Effect of Ursolic Acid of Loquat Extract on Function of Muscle

NCT ID: NCT02401113

Last Updated: 2015-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-10-31

Brief Summary

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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

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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

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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UA group

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

Group Type EXPERIMENTAL

UA group

Intervention Type DIETARY_SUPPLEMENT

Ursolic Acid of Loquat Extract, 500mg/ day during 12 weeks

placebo group

placebo group who takes a placebo, 500 mg/day for 12 weeks

Group Type PLACEBO_COMPARATOR

UA group

Intervention Type DIETARY_SUPPLEMENT

Ursolic Acid of Loquat Extract, 500mg/ day during 12 weeks

Interventions

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UA group

Ursolic Acid of Loquat Extract, 500mg/ day during 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* BMI 18.5-30KG/M2

Exclusion Criteria

* \> SERUM creatinine 1.2mg/dL
* \> AST or ALT 60IU/L
* DM Patients
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pusan National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sang Yeoup Lee

family medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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SANG YEOUP Lee, Pf.

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yangsan Hospital

References

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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.

Reference Type RESULT
PMID: 25973477 (View on PubMed)

Cho 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.

Reference Type DERIVED
PMID: 27999607 (View on PubMed)

Other Identifiers

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UrsolicAcid

Identifier Type: -

Identifier Source: org_study_id

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