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Blood Pressure Lowering Effect of Supplementation With Korea Red Ginseng Associated With Reductions in Circulating Lp-PLA2 Activity and Lysophospatidylcholines and an Increase in Dihydrobiopterin in Prehypertensive Subjects

Primary Purpose

Prehypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
KRG
Placebo
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prehypertension

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • nondiabetic, nonobese and prehypertensive subjects with blood pressures ranging 120 - 139 mmHg (systolic) or 80-89 mmHg (diastolic) were enrolled in this study.

Exclusion Criteria:

  • exclusion criteria included previous diagnosed clinical hypertension
  • self-reported use of antihypertensive medication
  • abnormal liver or renal function
  • history of cardiovascular disease
  • kidney disease
  • cancer
  • thyroid or pituitary disease or any other serious life-threatening illness that required regular medical treatment
  • we also excluded women who were pregnant, breast feeding or intending to become pregnant during the time of study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    KRG

    Placebo

    Arm Description

    5g Korea red ginseng (KRG)

    5 g placebo (corn starch)

    Outcomes

    Primary Outcome Measures

    changes from baselilne in blood pressure

    Secondary Outcome Measures

    changes from baseline in plasma metabolites

    Full Information

    First Posted
    December 22, 2014
    Last Updated
    December 26, 2014
    Sponsor
    Yonsei University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02326766
    Brief Title
    Blood Pressure Lowering Effect of Supplementation With Korea Red Ginseng Associated With Reductions in Circulating Lp-PLA2 Activity and Lysophospatidylcholines and an Increase in Dihydrobiopterin in Prehypertensive Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2011 (undefined)
    Primary Completion Date
    February 2012 (Actual)
    Study Completion Date
    March 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yonsei University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study evaluated effects of red ginseng consumption on blood pressure (BP) and fasting plasma metabolomes.
    Detailed Description
    A randomized, double-blind, placebo-controlled study was conducted on nonobese, nondiabetic and prehypertensive subjects. Over a 12 week test period, the red ginseng group (n=31) consumed 10 capsules (total 5g) daily containing red ginseng, while the placebo group (n=31) consumed the same product without red ginseng. Fasting plasma metabolomes were profiled using UPLC-LTQ-Orbitrap mass spectrometry.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    KRG
    Arm Type
    Experimental
    Arm Description
    5g Korea red ginseng (KRG)
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    5 g placebo (corn starch)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    KRG
    Intervention Description
    5g Korea red ginseng (KRG)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    5g placebo
    Primary Outcome Measure Information:
    Title
    changes from baselilne in blood pressure
    Time Frame
    12 week
    Secondary Outcome Measure Information:
    Title
    changes from baseline in plasma metabolites
    Time Frame
    12 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: nondiabetic, nonobese and prehypertensive subjects with blood pressures ranging 120 - 139 mmHg (systolic) or 80-89 mmHg (diastolic) were enrolled in this study. Exclusion Criteria: exclusion criteria included previous diagnosed clinical hypertension self-reported use of antihypertensive medication abnormal liver or renal function history of cardiovascular disease kidney disease cancer thyroid or pituitary disease or any other serious life-threatening illness that required regular medical treatment we also excluded women who were pregnant, breast feeding or intending to become pregnant during the time of study.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26843120
    Citation
    Cha TW, Kim M, Kim M, Chae JS, Lee JH. Blood pressure-lowering effect of Korean red ginseng associated with decreased circulating Lp-PLA2 activity and lysophosphatidylcholines and increased dihydrobiopterin level in prehypertensive subjects. Hypertens Res. 2016 Jun;39(6):449-56. doi: 10.1038/hr.2016.7. Epub 2016 Feb 4.
    Results Reference
    derived

    Learn more about this trial

    Blood Pressure Lowering Effect of Supplementation With Korea Red Ginseng Associated With Reductions in Circulating Lp-PLA2 Activity and Lysophospatidylcholines and an Increase in Dihydrobiopterin in Prehypertensive Subjects

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