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Home > "C" Clinical Trials Conditions > Comparing Effects of 3 Sources of Garlic on Cholesterol Levels  Comparing Effects of 3 Sources of Garlic on Cholesterol Levels
Comparing Effects of 3 Sources of Garlic on Cholesterol Levels
For Condition: Hypercholesterolemia
Status: Recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 30 Years/65 Years
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 220
Location and Contact Information:
Stanford Center for Research in Disease Prevention *Recruiting*
Palo Alto, California, 94304-1583
United States
Recruiting Christopher Gardner 650-725-2751
Additional Information:
Study ID Numbers: 1 R01 AT01108-01;
Study Start Date: May 2002
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056511
Other Hypercholesterolemia Studies:
1. Postprandial Lipemia and Endothelial Function in ACCORD- Ancillary to ACCORD
2. Population-Based Modeling of Cholesterol Lowering in the United States
3. Cholesterol Reduction in Seniors Program (CRISP)
4. Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients with Dyslipidemia (OCEANS)
5. Safety and Effectiveness of Flaxseed for Reducing High Cholesterol
Related Studies:
Other Hypercholesterolemia Clinical Trials
Other California Clinical Trials
Other Palo Alto Clinical Trials
Comparing Effects of 3 Sources of Garlic on Cholesterol Levels
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