Effect of Ursolic Acid of Loquat Extract on Function of Muscle

Sarcopenia Clinical Trial

Official title:

Effect of Ursolic Acid of Loquat Extract on Function of Muscle in Human

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401113
• Other study ID #: UrsolicAcid
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 24, 2015
• Last updated: October 30, 2015
• Start date: November 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Pusan National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI 18.5-30KG/M2

Exclusion Criteria:

• > SERUM creatinine 1.2mg/dL

• > AST or ALT 60IU/L

• DM Patients

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• UA group
Ursolic Acid of Loquat Extract, 500mg/ day during 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quadriceps muscle function		12weeks	No
Secondary	ASM(appendicular skeletal mass) marker		12weeks	No
Secondary	Short Physical Performance Battery, SPPB		12weeks	No