NCT01951443

Brief Summary

The purpose of the study is to evaluate the acute effect of a standardized extract of KRG (Rg3-KRG) consisting of 30% total ginsenosides, including 10% Rg3 ginsenoside on arterial stiffness and blood pressure, as measured by the following parameters: aortic augmentation index, peripheral blood pressure, central blood pressure

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 26, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Last Updated

April 28, 2014

Status Verified

March 1, 2014

Enrollment Period

6 months

First QC Date

August 21, 2013

Last Update Submit

April 25, 2014

Conditions

Arterial Stiffness, Blood Pressure

Keywords

ginsengclinical trialvascularginsenosidesblood pressure

Outcome Measures

Primary Outcomes (1)

  • To evaluate the acute effect of Rg3-KRG on arterial stiffness in healthy adult volunteers, as measured by aortic augmentation index (AIx).

    Two weeks (measurements taken on two separate visits with minimum one week washout)

Secondary Outcomes (1)

  • To evaluate the acute effect of Rg3-KRG on aortic and brachial blood pressure in healthy adult volunteers.

    Two weeks (measurements taken on two separate visits with minimum one week washout)

Other Outcomes (1)

  • To evaluate the acute safety of Rg3-KRG in healthy adult volunteers using a 48hr symptoms questionnaire.

    Two weeks

Study Arms (2)

Ginseng

EXPERIMENTAL

Encapsulated 400mg Rg3-KRG extract

Dietary Supplement: Ginseng

Wheat Bran

PLACEBO COMPARATOR

400mg Wheat Bran capsule

Dietary Supplement: Wheat Bran

Interventions

GinsengDIETARY_SUPPLEMENT

400mg of encapsulated Rg3-KRG

Ginseng
Wheat BranDIETARY_SUPPLEMENT

400mg of encapsulated wheat bran

Wheat Bran

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy
  • Age 18-70 years
  • BMI \< 30 kg/m2
  • Brachial systolic blood pressure \< 140 mmHg
  • Brachial diastolic blood pressure \< 90 mmHg

You may not qualify if:

  • BMI \>30kg/m2
  • Hypertensive (brachial systolic BP ≥140mmHg and/or diastolic BP ≥90mmHg)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Interventions

Asian ginsengDietary Fiber

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Dr. Vladimir Vuksan, PhD

    Risk Factor Modification Centre - St. Michael's Hospital

    PRINCIPAL INVESTIGATOR

  • Dr. Amir Hanna (Qualified investigator), MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2013

First Posted

September 26, 2013

Study Start

August 1, 2013

Primary Completion

February 1, 2014

Last Updated

April 28, 2014

Record last verified: 2014-03

Locations

CA(1)