Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056511
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2003-03-14
Brief Title:
Comparing Effects of 3 Sources of Garlic on Cholesterol Levels
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Comparing Effects of 3 Sources of Garlic on Serum Lipids
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None