ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Comparing Effects of 3 Sources of Garlic on Cholesterol Levels

This study has been completed.

Sponsors and Collaborators: National Center for Complementary and Alternative Medicine (NCCAM)
Office of Dietary Supplements (ODS)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00056511
  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.


Condition Intervention Phase
Hypercholesterolemia
Drug: Fresh garlic or garlic supplements
Phase II
Phase III

Genetics Home Reference related topics:   hypercholesterolemia   

MedlinePlus related topics:   Cholesterol    Dietary Supplements   

ChemIDplus related topics:   Cholest-5-en-3-ol (3beta)-    Allium sativum extract    Lipids   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Comparing Effects of 3 Sources of Garlic on Serum Lipids

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • LDL-cholesterol; measured at baseline, once a month, and post-intervention

Secondary Outcome Measures:
  • 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

Estimated Enrollment:   220
Study Start Date:   May 2002
Estimated Study Completion Date:   April 2005

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.

  Eligibility
Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056511

Locations
United States, California
Stanford Center for Research in Disease Prevention    
      Palo Alto, California, United States, 94304-1583

Sponsors and Collaborators

Investigators
Principal Investigator:     Christopher D. Gardner, Ph.D.     Stanford Center for Research in Disease Prevention    
  More Information


Publications indexed to this study:

Study ID Numbers:   R01 AT001108-01
First Received:   March 14, 2003
Last Updated:   August 16, 2006
ClinicalTrials.gov Identifier:   NCT00056511
Health Authority:   United States: Food and Drug Administration

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Garlic  
Supplements  
Adults  
Hypercholesterolemics  
Randomized Clinical Trial  

Study placed in the following topic categories:
Metabolic Diseases
Hyperlipidemias
Metabolic disorder
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on October 10, 2008




Links to all studies - primarily for crawlers