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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT01293591
Date of registration: 08/02/2011
Primary sponsor: United States Department of Agriculture
Public title: Garlic Intake And Biomarkers Of Cancer Risk
Scientific title: GARLIC INTAKE AND BIOMARKERS OF CANCER RISK
Date of first enrolment: July 2010
Target sample size: 18
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01293591
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind  
Countries of recruitment
Contacts
Key inclusion & exclusion criteria

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



Age minimum: 40 Years
Age maximum: 80 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Healthy Men
Healthy Women
Intervention(s)
Other: Controlled diet with or without garlic
Primary Outcome(s)
Biomarkers of inflammation [Time Frame: Day 11 of each treatment period -- before and 3 hours after treatment]
DNA damage [Time Frame: Day 11 of each treatment period -- before and 3 hours after treatment]
Garlic metabolites [Time Frame: Day 11 of each treatment period -- before and 3 hours after treatment]
Markers of gene expression [Time Frame: Day 11 of each treatment period -- before and 3 hours after treatment]
Oxidative stress [Time Frame: Day 11 of each treatment period -- before and 3 hours after treatment]
Secondary Outcome(s)
Secondary ID(s)
Garlic Study 2010
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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