Comparing Effects of 3 Sources of Garlic on Cholesterol Levels
1 other identifier
interventional
220
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2002
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedFirst Submitted
Initial submission to the registry
March 14, 2003
CompletedFirst Posted
Study publicly available on registry
March 18, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedAugust 18, 2006
August 1, 2006
March 14, 2003
August 16, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LDL-cholesterol; measured at baseline, once a month, and post-intervention
Secondary Outcomes (4)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford Center for Research in Disease Prevention
Palo Alto, California, 94304-1583, United States
Related Publications (1)
Gardner CD, Lawson LD, Block E, Chatterjee LM, Kiazand A, Balise RR, Kraemer HC. Effect of raw garlic vs commercial garlic supplements on plasma lipid concentrations in adults with moderate hypercholesterolemia: a randomized clinical trial. Arch Intern Med. 2007 Feb 26;167(4):346-53. doi: 10.1001/archinte.167.4.346.
PMID: 17325296DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher D. Gardner, Ph.D.
Stanford Center for Research in Disease Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
March 14, 2003
First Posted
March 18, 2003
Study Start
May 1, 2002
Study Completion
April 1, 2005
Last Updated
August 18, 2006
Record last verified: 2006-08