Comparing Effects of 3 Sources of Garlic on Cholesterol Levels

Study Overview
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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.

Official Title
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Comparing Effects of 3 Sources of Garlic on Serum Lipids

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: Fresh garlic or garlic supplements


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fresh garlic or garlic supplements|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-cholesterol; measured at baseline, once a month, and post-intervention |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Garlic, Supplements, Adults, Hypercholesterolemics, Randomized Clinical Trial