Healthy Men Clinical Trial
Official title:
Garlic Intake And Biomarkers Of Cancer Risk
Verified date | February 2011 |
Source | USDA Beltsville Human Nutrition Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is being done to study the healthful benefits of eating garlic. Previous studies suggest that garlic may help prevent cancer. The investigators are recruiting healthy volunteers to participate in a study to determine the ways in which eating garlic may reduce cancer risk.
Status | Completed |
Enrollment | 18 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Age 40-80 years Exclusion Criteria: - Younger than 40 years old or older than 80 years old - Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol (dicumarol), or Miradon (anisinidione) - Presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases or malabsorption syndromes. - Have been pregnant during the previous 12 months, are currently pregnant or lactating, or plan to become pregnant during the study - Follicle stimulating hormone levels above 35 mIU/mL serum - Type 2 diabetes requiring the use of oral antidiabetic agents or insulin - History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets) - Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanalamine, ephedrine, caffeine) during and for at least 6 months prior to the start of the study or a history of a surgical intervention for obesity - Active cardiovascular disease (such as a heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within the last three months, stroke, or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in the past six months). - Use of any tobacco products in past 6 months - Use of oral or IV antibiotics during the month preceding the study or during the study - Unwillingness to abstain from vitamin, mineral, and herbal supplements for two weeks prior to the study and during the study - Known (self-reported) allergy or adverse reaction to garlic - Inability to metabolize garlic - Unable or unwilling to give informed consent or communicate with study staff - Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (Long-term participation in Alcoholics Anonymous is not an exclusion) - Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol |
Country | Name | City | State |
---|---|---|---|
United States | USDA Beltsville Human Nutrition Research Center | Beltsville | Maryland |
Lead Sponsor | Collaborator |
---|---|
USDA Beltsville Human Nutrition Research Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Garlic metabolites | Garlic metabolites will be measured in blood and urine. | Day 11 of each treatment period -- before and 3 hours after treatment | |
Primary | Markers of gene expression | Lymphocyte microarray analysis, lymphocyte DNA genotyping. Microarray results will be confirmed by RT-PCR. | Day 11 of each treatment period -- before and 3 hours after treatment | |
Primary | DNA damage | Comet assay, 8-oxo-dG, histone analysis | Day 11 of each treatment period -- before and 3 hours after treatment | |
Primary | Oxidative stress | Serum nitrate/nitrite, malondyaldehyde, glutathione, glutathione reductase, glutathione S-transferase, catalase, protein carbonyls, F2-isoprostanes. | Day 11 of each treatment period -- before and 3 hours after treatment | |
Primary | Biomarkers of inflammation | C-reactive protein (CRP), vascular endothelial growth factor, IL-1, IL-6, TNF-a. | Day 11 of each treatment period -- before and 3 hours after treatment |
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