Comparing Effects of 3 Sources of Garlic on Cholesterol Levels
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Purpose
The purpose of this study is to determine whether fresh garlic can positively affect cholesterol in adults with moderately high cholesterol levels. This study will also determine whether the same effects can be found for two main types of garlic supplements: a dried powdered garlic (designed to yield the same effect as fresh garlic) and an aged garlic extract preparation.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Drug: Fresh garlic or garlic supplements |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Comparing Effects of 3 Sources of Garlic on Serum Lipids |
- LDL-cholesterol; measured at baseline, once a month, and post-intervention
- HDL-cholesterol; measured at baseline, once a month, and post-intervention
- Triacylglycerols; measured at baseline, once a month, and post-intervention
- Blood pressure; measured at baseline, once a month, and post-intervention
- Platelet aggregation; measured at baseline, once a month, and post-intervention
| Estimated Enrollment: | 220 |
| Study Start Date: | May 2002 |
| Estimated Study Completion Date: | April 2005 |
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.
Eligibility| Ages Eligible for Study: | 30 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, California | |
| Stanford Center for Research in Disease Prevention | |
| Palo Alto, California, United States, 94304-1583 | |
| Principal Investigator: | Christopher D. Gardner, Ph.D. | Stanford Center for Research in Disease Prevention |
More Information
No publications provided by National Center for Complementary and Alternative Medicine (NCCAM)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00056511 History of Changes |
| Other Study ID Numbers: | R01 AT001108-01 |
| Study First Received: | March 14, 2003 |
| Last Updated: | August 16, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
|
Garlic Supplements Adults Hypercholesterolemics Randomized Clinical Trial |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013