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OpenTrials
Completed

NCT Number: NCT02019368

Antioxidant Effect of Aged Garlic Extract

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.

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Key information

Conditions

Heavy Smoker or Non-smoker

Age range

40 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hiroshima University

Hiroshima, 734-8551, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

Aged Garlic Extract

Dietary Supplement

Primary outcomes

  1. Urinary 8-hydroxydeoxyguanosine (8-OHdG)

    Time frame: Every 4 weeks (Overall 12 weeks)

Secondary outcomes

  1. High sensitive CRP

    Time frame: Every 4 weeks (Overall 12 weeks)

  2. Blood pressure

    Time frame: Every 4 weeks (Overall 12 weeks)

  3. Indices of the second derivative of photoplethysmogram (SDPTG)

    Time frame: Every 4 weeks (Overall 12 weeks)

Sponsors and collaborators

Lead sponsor

Hiroshima University

Other

Collaborators

  • Wakunaga Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 24, 2013
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.