Heavy Smoker or Non-smoker Clinical Trial
Official title:
A Randomized, Double-blind, Placebo Controlled, Crossover Study to Evaluate the Antioxidant Effect of Aged Garlic Extract in Heavy Smokers
| Verified date | August 2015 |
| Source | Hiroshima University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | April 2015 |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 40 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Japan | Hiroshima University | Hiroshima |
| Lead Sponsor | Collaborator |
|---|---|
| Hiroshima University | Wakunaga Pharmaceutical Co., Ltd. |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Urinary 8-hydroxydeoxyguanosine (8-OHdG) | Every 4 weeks (Overall 12 weeks) | No | |
| Secondary | High sensitive CRP | Every 4 weeks (Overall 12 weeks) | No | |
| Secondary | Blood pressure | Every 4 weeks (Overall 12 weeks) | No | |
| Secondary | Indices of the second derivative of photoplethysmogram (SDPTG) | Every 4 weeks (Overall 12 weeks) | No |