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40 Years
80 Years
Not Enrolling
Healthy Men, Healthy Women

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Trial Information


A crossover design will be utilized with each participant completing each treatment phase,
and participants will be randomly assigned to a sequence of dietary treatments. There will
be a 17-day washout period in between diet periods. Participants will consume a garlic-free
diet for the first 10 days of each diet period. The dietary treatments will be administered
on day 11 of each diet period. Dietary treatments will be incorporated into food as follows:
1) 5 gram (0.175 oz.) of garlic mixed with 15 g margarine on top of 270 kcal white bread,
served as breakfast, or 2) 15 g margarine on top of 270 kcal white bread, served as

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind

Outcome Measure:

Garlic metabolites

Outcome Description:

Garlic metabolites will be measured in blood and urine.

Outcome Time Frame:

Day 11 of each treatment period -- before and 3 hours after treatment

Safety Issue:



United States: Federal Government

Study ID:

Garlic Study 2010



Start Date:

July 2010

Completion Date:

August 2010

Related Keywords:

  • Healthy Men
  • Healthy Women
  • Garlic
  • Cancer biomarkers
  • Gene expression
  • Oxidative stress
  • DNA damage



USDA Beltsville Human Nutrition Research Center Beltsville, Maryland  20705