NCT00056511

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
Last Updated

August 18, 2006

Status Verified

August 1, 2006

First QC Date

March 14, 2003

Last Update Submit

August 16, 2006

Conditions

Keywords

GarlicSupplementsAdultsHypercholesterolemicsRandomized Clinical Trial

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

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Christopher D. Gardner, Ph.D.

    Stanford Center for Research in Disease Prevention

    PRINCIPAL INVESTIGATOR

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

Locations