Comparing Effects of 3 Sources of Garlic on Cholesterol Levels

Hypercholesterolemia Clinical Trial

Official title:

Comparing Effects of 3 Sources of Garlic on Serum Lipids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00056511
• Other study ID #: R01AT001108-01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 14, 2003
• Last updated: August 16, 2006
• Start date: May 2002
• Est. completion date: April 2005

Study information

• Verified date: August 2006
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: April 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Fresh garlic or garlic supplements

Locations

Country	Name	City	State
United States	Stanford Center for Research in Disease Prevention	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)	Office of Dietary Supplements (ODS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-cholesterol; measured at baseline, once a month, and post-intervention
Secondary	HDL-cholesterol; measured at baseline, once a month, and post-intervention
Secondary	Triacylglycerols; measured at baseline, once a month, and post-intervention
Secondary	Blood pressure; measured at baseline, once a month, and post-intervention
Secondary	Platelet aggregation; measured at baseline, once a month, and post-intervention