Garlic Intake And Biomarkers Of Cancer Risk

• 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

United States

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 ID(s)

Garlic Study 2010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors