HealthyPhase 4NCT00275405
Effect of Garlic on Inflammatory Mediators
A Phase 4 study testing Garlic Oil Macerate in people with Healthy, run by Albany Medical College at 1 site in United States.
Trial summary
This research will investigate the effect of garlic oil extract when added to daily diet on inflammatory mediators and blood clotting activation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Garlic Oil Macerate
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Mar 2007
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- Normal subjects with BMI <25, obese subjects with BMI >30
- Subjects who have consented to adhere to the diet, regular weekly visits, and blood draws.
Who cannot join
- Subjects on any antioxidant medication.
- Patient on non-steroidal anti-inflammatory drug.
- On any agent with antioxidant properties.
- History of drug or alcohol abuse.
- Any life threatening disease.
- On any agent with significant antioxidant properties.
- Taking garlic extracts in the diet regularly.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Garlic Oil Macerate on Inflammatory Mediators in Healthy Normal Weight and Obese Subjects.
This research will investigate the effect of garlic oil extract when added to daily diet on inflammatory mediators and blood clotting activation.
Read the detailed description
To investigate the pharmacokinetics of one of the garlic oil macerate, Ajoene, the anti-inflammatory effect of garlic oil macerate on the pro-inflammatory transcription factor NF-kB, it's activating proteins, including IkB, IkB Kinases a and B (IKKa and IKKB) and the pro-inflammatory NF-kB-regulated proteins, c-reactive protein (CRP), tumor necrosis factor-alpha (TNF-a), soluble intercellular adhesion molecule-1 (sICAM-1), soluble vascular cell adhesion molecule-1 (sVCAM-1), matrix metalloproteinase-9 (MMP-9), plasminogen activated protein-1 (PAI-1)and the effect of garlic oil macerate intake on platelet activation in normal subjects.
- Conditions
- Healthy
- Being tested
- Garlic Oil Macerate
- Keywords
- Effects of Garlic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garlic Oil MacerateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
1. To examine the pharmacokinetics of the garlic oil macerate.
Secondary outcomes (1)
2. To examine the effect of garlic oil macerate on inflammatory mechanisms at the cellular and molecular level.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2006 (estimated)
- Study startApr 2006
- Study completionMar 2007 (estimated)
Why it stopped: Results inconclusive
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Investigators
- Howard S Smith, MD, Principal investigator, Albany Medical CollegeShaker A Mousa, PhD, Principal investigator, Albany College of PharmacyAhmad Aljada, PhD, Principal investigator, Albany College of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275405
- Sponsor's protocol ID
- Ajoene
- Status last verified
- Mar 2007
- First submitted
- 10 Jan 2006
- Last updated
- 20 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Garlic Oil Macerate on Inflammatory Mediators in Healthy Normal Weight and Obese Subjects.
- ClinicalTrials.gov ID
- NCT00275405
- Acronym / sponsor ID
- Ajoene
- Conditions
- Healthy
- Keywords
- Effects of Garlic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Results inconclusive
- Enrolment
- 34 participants
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- Apr 2006
- Study completion
- Mar 2007 (estimated)
- First posted
- 12 Jan 2006 (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 research will investigate the effect of garlic oil extract when added to daily diet on inflammatory mediators and blood clotting activation.
Detailed description
To investigate the pharmacokinetics of one of the garlic oil macerate, Ajoene, the anti-inflammatory effect of garlic oil macerate on the pro-inflammatory transcription factor NF-kB, it's activating proteins, including IkB, IkB Kinases a and B (IKKa and IKKB) and the pro-inflammatory NF-kB-regulated proteins, c-reactive protein (CRP), tumor necrosis factor-alpha (TNF-a), soluble intercellular adhesion molecule-1 (sICAM-1), soluble vascular cell adhesion molecule-1 (sVCAM-1), matrix metalloproteinase-9 (MMP-9), plasminogen activated protein-1 (PAI-1)and the effect of garlic oil macerate intake on platelet activation in normal subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age and older
- Normal subjects with BMI <25, obese subjects with BMI >30
- Subjects who have consented to adhere to the diet, regular weekly visits, and blood draws.
Key exclusion criteria (7 listed)
- Subjects on any antioxidant medication.
- Patient on non-steroidal anti-inflammatory drug.
- On any agent with antioxidant properties.
- History of drug or alcohol abuse.
- Any life threatening disease.
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 |
|---|---|---|
| Garlic Oil Macerate | Drug | – |
Primary outcome
1. To examine the pharmacokinetics of the garlic oil macerate.
1 secondary outcome
2. To examine the effect of garlic oil macerate on inflammatory mechanisms at the cellular and molecular level.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2007.
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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.
Howard S Smith, MD principal investigator
Albany Medical College
Shaker A Mousa, PhD principal investigator
Albany College of Pharmacy
Ahmad Aljada, PhD principal investigator
Albany College of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Garlic Oil Macerate in people with Healthy, run by Albany Medical College at 1 site in United States.
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 3 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: paused, as of the sponsor's last update on 20 Mar 2007. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
1. To examine the pharmacokinetics of the garlic oil macerate.. 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 20 Mar 2007.