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Comparing Effects of 3 Sources of Garlic on Cholesterol Levels

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fresh garlic or garlic supplements
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Garlic, Supplements, Adults, Hypercholesterolemics, Randomized Clinical Trial

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford Center for Research in Disease Prevention

Outcomes

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

Full Information

First Posted
March 14, 2003
Last Updated
August 16, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Office of Dietary Supplements (ODS)
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1. Study Identification

Unique Protocol Identification Number
NCT00056511
Brief Title
Comparing Effects of 3 Sources of Garlic on Cholesterol Levels
Official Title
Comparing Effects of 3 Sources of Garlic on Serum Lipids
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Office of Dietary Supplements (ODS)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Garlic, Supplements, Adults, Hypercholesterolemics, Randomized Clinical Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
220 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fresh garlic or garlic supplements
Primary Outcome Measure Information:
Title
LDL-cholesterol; measured at baseline, once a month, and post-intervention
Secondary Outcome Measure Information:
Title
HDL-cholesterol; measured at baseline, once a month, and post-intervention
Title
Triacylglycerols; measured at baseline, once a month, and post-intervention
Title
Blood pressure; measured at baseline, once a month, and post-intervention
Title
Platelet aggregation; measured at baseline, once a month, and post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher D. Gardner, Ph.D.
Organizational Affiliation
Stanford Center for Research in Disease Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Center for Research in Disease Prevention
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1583
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17325296
Citation
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.
Results Reference
derived

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Comparing Effects of 3 Sources of Garlic on Cholesterol Levels

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