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.
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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Hypercholesterolemia
Fresh garlic or garlic supplements
Stanford Center for Research in Disease Prevention
Palo Alto
California
United States
94304-1583
Completed
National Center for Complementary and Alternative Medicine (NCCAM)
Published on BioPortfolio: 2014-08-27T03:55:26-0400
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Shallots
Mildly aromatic herb in the Allium genus related to ONIONS and garlic used in SPICES.
Chara
A genus of ALGAE in the family CHARACEAE. They have a strong garlic-like odor and are an important food source for waterfowl.
Garlic
Allium sativum. One of the Liliaceae used as a spice and traditional remedy. It contains allicin, the pungent active ingredient, which may reduce blood cholesterol and inhibit platelet aggregation.
Estuaries
A partially enclosed body of water, and its surrounding coastal habitats, where saltwater from the ocean mixes with fresh water from rivers or streams. The resulting mixture of seawater and fresh water is called brackish water and its salinity can range from 0.5 to 35 ppt. (accessed http://oceanservice.noaa.gov/education/kits/estuaries/estuaries01_whatis.html)
Colesevelam Hydrochloride
An allylamine derivative that binds BILE ACIDS in the intestine and is used as an ANTICHOLESTEREMIC AGENT in the treatment of HYPERCHOLESTEROLEMIA and HYPERLIPIDEMIAS.