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Antioxidant Effect of Aged Garlic Extract

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02019368
Enrollment
60
Registered
2013-12-24
Start date
2013-11-30
Completion date
2015-04-30
Last updated
2015-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heavy Smoker or Non-smoker

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTPlacebo
DIETARY_SUPPLEMENTAged garlic extract

Sponsors

Wakunaga Pharmaceutical Co., Ltd.
CollaboratorINDUSTRY
Hiroshima University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
40 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Urinary 8-hydroxydeoxyguanosine (8-OHdG)Every 4 weeks (Overall 12 weeks)

Secondary

MeasureTime frame
High sensitive CRPEvery 4 weeks (Overall 12 weeks)
Blood pressureEvery 4 weeks (Overall 12 weeks)
Indices of the second derivative of photoplethysmogram (SDPTG)Every 4 weeks (Overall 12 weeks)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026