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NCT02326766 Clinical 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

Prehypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02326766
Other study ID # KGC_metabolites_14121
Secondary ID
Status Completed
Phase Phase 3
First received December 22, 2014
Last updated December 26, 2014
Start date November 2011
Est. completion date March 2012

Study information
Verified date December 2014
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date March 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• KRG
5g Korea red ginseng (KRG)
• Placebo
5g placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Outcome
Type Measure Description Time frame Safety issue
Primary changes from baselilne in blood pressure 12 week Yes
Secondary changes from baseline in plasma metabolites 12 week Yes
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