Heavy Smoker or Non-smokerNCT02019368
Antioxidant Effect of Aged Garlic Extract
A study testing Aged garlic extract in people with Heavy Smoker or Non-smoker, run by Hiroshima University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heavy Smoker or Non-smoker
- What is being tested?
- Aged garlic extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smoking (at least 20 cigarettes per day) or non-smoking (more than 20 years)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Heavy Smoker or Non-smoker
- Being tested
- Placebo, Aged garlic extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Aged garlic extractDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Smoker subjects take 6 capsules once a day for 4 weeks. Receives: Dietary Supplement: Placebo |
| Aged garlic extract | Experimental | Smoker subjects take 1.5 g of aged garlic extract in 6 capsules once a day for 4 weeks. Receives: Dietary Supplement: Aged garlic extract |
| Non-smoker | No intervention | Oxidative status in non-smoker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary 8-hydroxydeoxyguanosine (8-OHdG)
Measured: Every 4 weeks (Overall 12 weeks)
Secondary outcomes (3)
High sensitive CRP
Measured: Every 4 weeks (Overall 12 weeks)
Blood pressure
Measured: Every 4 weeks (Overall 12 weeks)
Indices of the second derivative of photoplethysmogram (SDPTG)
Measured: Every 4 weeks (Overall 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy Smoker or Non-smokerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Collaborators
- Wakunaga Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Fumiko Higashikawa, Hiroshima University
- Investigators
- Fumiko Higashikawa, PhD, Principal investigator, Hiroshima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019368
- Sponsor's protocol ID
- eki-843
- Status last verified
- Aug 2015
- First submitted
- 18 Dec 2013
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled, Crossover Study to Evaluate the Antioxidant Effect of Aged Garlic Extract in Heavy Smokers
- ClinicalTrials.gov ID
- NCT02019368
- Acronym / sponsor ID
- eki-843
- Conditions
- Heavy Smoker or Non-smoker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Collaborators
- Wakunaga Pharmaceutical Co., Ltd.
- Study start
- Nov 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 24 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSmoker subjects take 6 capsules once a day for 4 weeks. |
| Aged garlic extract | Experimental | Dietary Supplement: Aged garlic extractSmoker subjects take 1.5 g of aged garlic extract in 6 capsules once a day for 4 weeks. |
| Non-smoker | No intervention | –Oxidative status in non-smoker |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Smoking (at least 20 cigarettes per day) or non-smoking (more than 20 years)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo | Dietary supplement | Placebo |
| Aged garlic extract | Dietary supplement | Aged garlic extract |
Primary outcome
Urinary 8-hydroxydeoxyguanosine (8-OHdG)
Time frame: Every 4 weeks (Overall 12 weeks)
3 secondary outcomes
High sensitive CRP
Time frame: Every 4 weeks (Overall 12 weeks)
Blood pressure
Time frame: Every 4 weeks (Overall 12 weeks)
Indices of the second derivative of photoplethysmogram (SDPTG)
Time frame: Every 4 weeks (Overall 12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fumiko Higashikawa, PhD principal investigator
Hiroshima University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aged garlic extract in people with Heavy Smoker or Non-smoker, run by Hiroshima University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary 8-hydroxydeoxyguanosine (8-OHdG) (time frame: Every 4 weeks (Overall 12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.