Effect of Aged Garlic Extract on Atherosclerosis (Garlic4)

This study has been completed.
Sponsor:
Collaborator:
Wakunaga Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT01534910
First received: February 14, 2012
Last updated: March 19, 2015
Last verified: February 2015
Results First Received: February 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Metabolic Syndrome
Interventions: Drug: aged garlic extract
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
all 65 participants were recruited

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sugar Pill

placebo

placebo: placebo

Aged Garlic Extract

2400 mg of aged garlic extract

aged garlic extract: 2400 mg a day


Participant Flow:   Overall Study
    Sugar Pill     Aged Garlic Extract  
STARTED     33     32  
COMPLETED     29     28  
NOT COMPLETED     4     4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sugar Pill

placebo

placebo: placebo patients were randomized to placebo

Aged Garlic Extract

2400 mg of aged garlic extract

aged garlic extract: 2400 mg a day patients randomized to aged garlic extract

Total Total of all reporting groups

Baseline Measures
    Sugar Pill     Aged Garlic Extract     Total  
Number of Participants  
[units: participants]
  33     32     65  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     33     32     65  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  57  (7)     56  (8)     57  (7)  
Gender  
[units: participants]
     
Female     9     8     17  
Male     24     24     48  
Region of Enrollment  
[units: participants]
     
United States     33     32     65  



  Outcome Measures

1.  Primary:   CT Angiography Plaque   [ Time Frame: 1 year ]

2.  Secondary:   Coronary Calcium   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Serum Biomarkers   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Carotid IMT   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Matthew Budoff
Organization: Los Angeles Biomedical Research Institute
phone: 310-222-4107
e-mail: mbudoff@labiomed.org


No publications provided


Responsible Party: Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT01534910     History of Changes
Other Study ID Numbers: Garlic4
Study First Received: February 14, 2012
Results First Received: February 20, 2015
Last Updated: March 19, 2015
Health Authority: United States: Institutional Review Board