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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

NCT ID: NCT02326766

Last Updated: 2014-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-03-31

Brief Summary

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This study evaluated effects of red ginseng consumption on blood pressure (BP) and fasting plasma metabolomes.

Detailed Description

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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.

Conditions

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Prehypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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KRG

5g Korea red ginseng (KRG)

Group Type EXPERIMENTAL

KRG

Intervention Type DIETARY_SUPPLEMENT

5g Korea red ginseng (KRG)

Placebo

5 g placebo (corn starch)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

5g placebo

Interventions

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KRG

5g Korea red ginseng (KRG)

Intervention Type DIETARY_SUPPLEMENT

Placebo

5g placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 26843120 (View on PubMed)

Other Identifiers

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KGC_metabolites_14121

Identifier Type: -

Identifier Source: org_study_id