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Effect of Rubus Occidentalis Extract on Plasma Glucose Levels in Subject With Prediabetes

Primary Purpose

Prediabetes (Impaired Fasting Glucose and/or Impaired Glucose Tolerance)

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Rubus occidentalis extract
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prediabetes (Impaired Fasting Glucose and/or Impaired Glucose Tolerance)

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 19 years of age or older
  • prediabetes (fasting plasma glucose 100-125mg/dl, and/or post 75g OGTT plasma glucose 140-199mg/dl)

Exclusion Criteria:

  • pregnant women
  • taking anti-hyperglycemic agents within 3 months at the time of enrollment
  • history of heart failure, myocardial infarction, cerebral infarction
  • uncontrolled hypertension (systolic BP > 160mmHg, or diastolic BP > 100mmHg)
  • serum triglyceride level > 500mg/dl
  • kidney dysfunction (serum Creatinine > 30% of upper normal limits)
  • hepatic dysfunction (AST, ALT > 3 times of upper normal limits)
  • taking systemic glucocorticoids within 1 month

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    control

    Rubus occidentalis extract 900mg

    Rubus occidentalis extract 1800mg

    Arm Description

    taking Rubus occidentalis extract 900mg/day for 12weeks

    taking Rubus occidentalis extract 1800mg/day for 12weeks

    Outcomes

    Primary Outcome Measures

    serum glucose (fasting and post 75g oral glucose tolerance test)

    Secondary Outcome Measures

    serum insulin

    Full Information

    First Posted
    October 14, 2013
    Last Updated
    October 14, 2013
    Sponsor
    Korea University Anam Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01964703
    Brief Title
    Effect of Rubus Occidentalis Extract on Plasma Glucose Levels in Subject With Prediabetes
    Official Title
    Effect of Rubus Occidentalis Extract on Plasma Glucose Levels in Subject With Prediabetes; A Proof-of-concept, Randomized, Double-blind, Parallel-group Placebo-controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    October 2013 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Korea University Anam Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether Rubus occidentalis extract could improve fasting or postprandial serum glucose levels, and related metabolic markers among patients with prediabetes (impaired fasting glucose and/or impaired glucose tolerance).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prediabetes (Impaired Fasting Glucose and/or Impaired Glucose Tolerance)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    29 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    control
    Arm Type
    Placebo Comparator
    Arm Title
    Rubus occidentalis extract 900mg
    Arm Type
    Active Comparator
    Arm Description
    taking Rubus occidentalis extract 900mg/day for 12weeks
    Arm Title
    Rubus occidentalis extract 1800mg
    Arm Type
    Active Comparator
    Arm Description
    taking Rubus occidentalis extract 1800mg/day for 12weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Rubus occidentalis extract
    Primary Outcome Measure Information:
    Title
    serum glucose (fasting and post 75g oral glucose tolerance test)
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    serum insulin
    Time Frame
    12 weeks
    Other Pre-specified Outcome Measures:
    Title
    HOMA IR, QUICKI, HOMA beta, lipid profile, inflammatory markers
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 19 years of age or older prediabetes (fasting plasma glucose 100-125mg/dl, and/or post 75g OGTT plasma glucose 140-199mg/dl) Exclusion Criteria: pregnant women taking anti-hyperglycemic agents within 3 months at the time of enrollment history of heart failure, myocardial infarction, cerebral infarction uncontrolled hypertension (systolic BP > 160mmHg, or diastolic BP > 100mmHg) serum triglyceride level > 500mg/dl kidney dysfunction (serum Creatinine > 30% of upper normal limits) hepatic dysfunction (AST, ALT > 3 times of upper normal limits) taking systemic glucocorticoids within 1 month

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27279471
    Citation
    An JH, Kim DL, Lee TB, Kim KJ, Kim SH, Kim NH, Kim HY, Choi DS, Kim SG. Effect of Rubus Occidentalis Extract on Metabolic Parameters in Subjects with Prediabetes: A Proof-of-concept, Randomized, Double-blind, Placebo-controlled Clinical Trial. Phytother Res. 2016 Oct;30(10):1634-1640. doi: 10.1002/ptr.5664. Epub 2016 Jun 9.
    Results Reference
    derived

    Learn more about this trial

    Effect of Rubus Occidentalis Extract on Plasma Glucose Levels in Subject With Prediabetes

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