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Comparing Effects of 3 Sources of Garlic on Cholesterol Levels

NCT ID: NCT00056511

Last Updated: 2006-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2005-04-30

Brief Summary

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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

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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.

Conditions

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Hypercholesterolemia

Keywords

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Garlic Supplements Adults Hypercholesterolemics Randomized Clinical Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Fresh garlic or garlic supplements

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Office of Dietary Supplements (ODS)

NIH

Sponsor Role collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Principal Investigators

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Christopher D. Gardner, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford Center for Research in Disease Prevention

Locations

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Stanford Center for Research in Disease Prevention

Palo Alto, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 17325296 (View on PubMed)

Other Identifiers

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R01AT001108-01

Identifier Type: NIH

Identifier Source: org_study_id

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