Effect of Ursolic Acid of Loquat Extract on Function of Muscle

October 30, 2015 updated by: Sang Yeoup Lee, Pusan National University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI 18.5-30KG/M2

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Dietary supplement: UA group
Ursolic Acid of Loquat Extract, 500mg/ day during 12 weeks
Placebo Comparator: placebo group
placebo group who takes a placebo, 500 mg/day for 12 weeks
Dietary supplement: UA group
Ursolic Acid of Loquat Extract, 500mg/ day during 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
quadriceps muscle function
Time Frame: 12weeks
12weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
ASM(appendicular skeletal mass) marker
Time Frame: 12weeks
12weeks
Short Physical Performance Battery, SPPB
Time Frame: 12weeks
12weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Hospital

Investigators

  • Principal Investigator: SANG YEOUP Lee, Pf., Pusan National University Yangsan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

March 26, 2015

First Posted (Estimate)

March 27, 2015

Study Record Updates

Last Update Posted (Estimate)

November 3, 2015

Last Update Submitted That Met QC Criteria

October 30, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UrsolicAcid

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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