Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Palo Alto, California 94304


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.


Study summary:

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.


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


Study is Available At:


Original ID:

R01 AT001108-01


NCT ID:

NCT00056511


Secondary ID:


Study Acronym:


Brief Title:

Comparing Effects of 3 Sources of Garlic on Cholesterol Levels


Official Title:

Comparing Effects of 3 Sources of Garlic on Serum Lipids


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

Both


Minimum Age:

30 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Center for Complementary and Alternative Medicine (NCCAM)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

220


Enrollment Type:


Overall Contact Information

Official Name:Christopher D. Gardner, Ph.D.
Principal Investigator
Stanford Center for Research in Disease Prevention

Study Dates

Start Date:May 2002
Completion Date:April 2005
Verification Date:August 2006
Last Changed Date:August 16, 2006
First Received Date:March 14, 2003

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Platelet aggregation; measured at baseline, once a month, and post-intervention
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Blood pressure; measured at baseline, once a month, and post-intervention
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Triacylglycerols; measured at baseline, once a month, and post-intervention
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:HDL-cholesterol; measured at baseline, once a month, and post-intervention
Safety Issues:False
Outcome Type:Primary Outcome
Measure:LDL-cholesterol; measured at baseline, once a month, and post-intervention
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Fresh garlic or garlic supplements

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Center for Complementary and Alternative Medicine (NCCAM)
Agency Class:NIH
Agency Type:Collaborator
Agency Name:Office of Dietary Supplements (ODS)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.