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Effect of Ursolic Acid of Loquat Extract on Function of Muscle

Primary Purpose

Sarcopenia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
UA group
Sponsored by
Pusan National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI 18.5-30KG/M2

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    UA group

    placebo group

    Arm Description

    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

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

    Outcomes

    Primary Outcome Measures

    quadriceps muscle function

    Secondary Outcome Measures

    ASM(appendicular skeletal mass) marker
    Short Physical Performance Battery, SPPB

    Full Information

    First Posted
    March 24, 2015
    Last Updated
    October 30, 2015
    Sponsor
    Pusan National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02401113
    Brief Title
    Effect of Ursolic Acid of Loquat Extract on Function of Muscle
    Official Title
    Effect of Ursolic Acid of Loquat Extract on Function of Muscle in Human
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pusan National University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sarcopenia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    UA group
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    placebo group who takes a placebo, 500 mg/day for 12 weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    UA group
    Intervention Description
    Ursolic Acid of Loquat Extract, 500mg/ day during 12 weeks
    Primary Outcome Measure Information:
    Title
    quadriceps muscle function
    Time Frame
    12weeks
    Secondary Outcome Measure Information:
    Title
    ASM(appendicular skeletal mass) marker
    Time Frame
    12weeks
    Title
    Short Physical Performance Battery, SPPB
    Time Frame
    12weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: BMI 18.5-30KG/M2 Exclusion Criteria: > SERUM creatinine 1.2mg/dL > AST or ALT 60IU/L DM Patients
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    SANG YEOUP Lee, Pf.
    Organizational Affiliation
    Pusan National University Yangsan Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25973477
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    27999607
    Citation
    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.
    Results Reference
    derived

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    Effect of Ursolic Acid of Loquat Extract on Function of Muscle

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