Effect of Ursolic Acid of Loquat Extract on Function of Muscle

Phase 2

Completed

• Conditions: Sarcopenia

• Registration Number: NCT02401113
• Lead Sponsor: Pusan National University Hospital

Brief 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.

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 Timeline

• Study Start: 2014-11
• Primary Completion: 2015-02
• Study First Submitted: 2015-03-24
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-27
• Status Verified: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-30
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• BMI 18.5-30KG/M2

Exclusion Criteria

• > SERUM creatinine 1.2mg/dL
• > AST or ALT 60IU/L
• DM Patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
quadriceps muscle function	12weeks

Secondary Outcome Measures

Name	Time	Method
ASM(appendicular skeletal mass) marker	12weeks
Short Physical Performance Battery, SPPB	12weeks