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

Phase 3

Completed

• Conditions: Prehypertension
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: KRG

• Registration Number: NCT02326766
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-02
• Study Completion: 2012-03
• Status Verified: 2014-12
• Study First Submitted: 2014-12-22
• Study First Submitted QC: 2014-12-26
• Last Update Submitted: 2014-12-26
• Study First Posted: 2014-12-29
• Last Update Posted: 2014-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	5 g placebo (corn starch)
KRG	KRG	5g Korea red ginseng (KRG)

Primary Outcome Measures

Name	Time	Method
changes from baselilne in blood pressure	12 week

Secondary Outcome Measures

Name	Time	Method
changes from baseline in plasma metabolites	12 week