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

December 26, 2014 updated by: Yonsei University
This study evaluated effects of red ginseng consumption on blood pressure (BP) and fasting plasma metabolomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KRG
5g Korea red ginseng (KRG)
Dietary supplement: KRG
5g Korea red ginseng (KRG)
Placebo Comparator: Placebo
5 g placebo (corn starch)
Dietary supplement: Placebo
5g placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes from baselilne in blood pressure
Time Frame: 12 week
12 week

Secondary Outcome Measures

Outcome Measure
Time Frame
changes from baseline in plasma metabolites
Time Frame: 12 week
12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

December 22, 2014

First Submitted That Met QC Criteria

December 26, 2014

First Posted (Estimate)

December 29, 2014

Study Record Updates

Last Update Posted (Estimate)

December 29, 2014

Last Update Submitted That Met QC Criteria

December 26, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KGC_metabolites_14121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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