Antioxidant Effect of Aged Garlic Extract

August 17, 2015 updated by: Fumiko Higashikawa, Hiroshima University

A Randomized, Double-blind, Placebo Controlled, Crossover Study to Evaluate the Antioxidant Effect of Aged Garlic Extract in Heavy Smokers

This is a randomized, double-blind, placebo controlled, crossover study to determine the antioxidant effect of aged garlic extract. This study will also compare the oxidative status in heavy smokers with that in non-smokers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hiroshima, Japan, 734-8551
        • Hiroshima University

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

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Smoking (at least 20 cigarettes per day) or non-smoking (more than 20 years)

Exclusion Criteria:

  • Under medication for chronic disease
  • Garlic allergy
  • Engaging in vigorous exercise
  • Taking drugs or functional food that may possess antioxidant property
  • Participation in any clinical trial within 90 days of the commencement of the trial
  • Renal or hepatic dysfunction
  • Heart disease

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: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Smoker subjects take 6 capsules once a day for 4 weeks.
Dietary supplement: Placebo
Experimental: Aged garlic extract
Smoker subjects take 1.5 g of aged garlic extract in 6 capsules once a day for 4 weeks.
Dietary supplement: Aged garlic extract
No Intervention: Non-smoker
Oxidative status in non-smoker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urinary 8-hydroxydeoxyguanosine (8-OHdG)
Time Frame: Every 4 weeks (Overall 12 weeks)
Every 4 weeks (Overall 12 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
High sensitive CRP
Time Frame: Every 4 weeks (Overall 12 weeks)
Every 4 weeks (Overall 12 weeks)
Blood pressure
Time Frame: Every 4 weeks (Overall 12 weeks)
Every 4 weeks (Overall 12 weeks)
Indices of the second derivative of photoplethysmogram (SDPTG)
Time Frame: Every 4 weeks (Overall 12 weeks)
Every 4 weeks (Overall 12 weeks)

Collaborators and Investigators

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

Sponsor

Hiroshima University

Collaborators

Wakunaga Pharmaceutical Co., Ltd.

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, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

December 18, 2013

First Submitted That Met QC Criteria

December 18, 2013

First Posted (Estimate)

December 24, 2013

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • eki-843

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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