- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00056511
Comparing Effects of 3 Sources of Garlic on Cholesterol Levels
Comparing Effects of 3 Sources of Garlic on Serum Lipids
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Garlic supplements are the most consumed herbal products in the United States. The most common health claim made for garlic supplements is cholesterol lowering activity. This claim has not been supported by recent clinical trials and meta-analyses. However, data suggest that it is not necessarily the garlic that has been ineffective, but rather the particular garlic preparations being used. To date, the predominant type of garlic preparation used in these clinical trials has been dried garlic powders. A few clinical trials have reported beneficial lipid effects using an aged garlic extract, and only a small number of inconclusive uncontrolled trials have used fresh garlic. A rigorous trial directly comparing different types of garlic preparations for their effects on serum lipids is needed.
Adults with moderately elevated low density lipoprotein cholesterol (LDL-C) will be randomized to one of four groups for 6 months: fresh garlic, dried powdered garlic tablets, aged garlic extract tablets, or placebo control. The fresh garlic will be provided to patients with "study sandwiches"; all other groups will receive the same study sandwiches without the garlic. All patients will take daily study tablets, but the tablet assignment will be double-blind. Patients will pick up study sandwiches twice a week and study tablets once every 2 weeks for 28 weeks. Blood samples will be taken once a month, with additional blood draws at the start and end of the study.
Study Type
Enrollment
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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California
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Palo Alto, California, United States, 94304-1583
- Stanford Center for Research in Disease Prevention
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- LDL-C 130-190 mg/dL (fasting single sample)
- BMI (body mass index) 19-30 kg/m2 (42-66 lb/m2)
- Weight stable for last 2 months
- Not actively on a weight loss plan
- Ethnicity representative of local population
- No plans to move from the area over the next 9 months
Exclusion Criteria:
- Pregnant, lactating, within 6 months postpartum, or planning to become pregnant in the next year
- Diabetes (type I or II) or history of gestational diabetes
- Heart disease
- Active neoplasms
- Renal or liver disease
- Hyperthyroidism or hypothyroidism
- Lipid lowering medications (known to affect lipid metabolism, platelet function, or antioxidant status)
- Blood pressure medications
- Excessive alcohol intake (self reported, more than 3 drinks/day)
- Currently under psychiatric care or severely clinically depressed
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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LDL-cholesterol; measured at baseline, once a month, and post-intervention
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Secondary Outcome Measures
Outcome Measure |
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HDL-cholesterol; measured at baseline, once a month, and post-intervention
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Triacylglycerols; measured at baseline, once a month, and post-intervention
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Blood pressure; measured at baseline, once a month, and post-intervention
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Platelet aggregation; measured at baseline, once a month, and post-intervention
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Christopher D. Gardner, Ph.D., Stanford Center for Research in Disease Prevention
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AT001108-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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