Garlic Intake And Biomarkers Of Cancer Risk

This study has been completed.
Sponsor:
Information provided by:
USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01293591
First received: February 8, 2011
Last updated: February 9, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Healthy Men
Healthy Women
Other: Controlled diet with or without garlic

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Official Title: GARLIC INTAKE AND BIOMARKERS OF CANCER RISK

Resource links provided by NLM:


Further study details as provided by USDA Beltsville Human Nutrition Research Center:

Primary Outcome Measures:
  • Garlic metabolites [ Time Frame: Day 11 of each treatment period -- before and 3 hours after treatment ] [ Designated as safety issue: No ]
    Garlic metabolites will be measured in blood and urine.

  • Markers of gene expression [ Time Frame: Day 11 of each treatment period -- before and 3 hours after treatment ] [ Designated as safety issue: No ]
    Lymphocyte microarray analysis, lymphocyte DNA genotyping. Microarray results will be confirmed by RT-PCR.

  • DNA damage [ Time Frame: Day 11 of each treatment period -- before and 3 hours after treatment ] [ Designated as safety issue: No ]
    Comet assay, 8-oxo-dG, histone analysis

  • Oxidative stress [ Time Frame: Day 11 of each treatment period -- before and 3 hours after treatment ] [ Designated as safety issue: No ]
    Serum nitrate/nitrite, malondyaldehyde, glutathione, glutathione reductase, glutathione S-transferase, catalase, protein carbonyls, F2-isoprostanes.

  • Biomarkers of inflammation [ Time Frame: Day 11 of each treatment period -- before and 3 hours after treatment ] [ Designated as safety issue: No ]
    C-reactive protein (CRP), vascular endothelial growth factor, IL-1, IL-6, TNF-α.


Enrollment: 18
Study Start Date: July 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Garlic
Comparison of crushed garlic to control.
Other: Controlled diet with or without garlic
Each subject will complete each treatment phase, and subjects will be randomly assigned to a sequence of dietary treatments. Subjects will consume a garlic-free diet for 10 days. On day 11, subjects will consume one of two dietary treatments, consisting of either 1) 270 kcal white bread, 15 g margarine, and 5 g (0.175 oz.) of crushed garlic, or 2) 270 kcal white bread with 15 g margarine (during the control phase).

Detailed Description:

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 breakfast.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293591

Locations
United States, Maryland
USDA Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705
Sponsors and Collaborators
USDA Beltsville Human Nutrition Research Center
  More Information

No publications provided

Responsible Party: Janet Novotny, Ph. D., USDA
ClinicalTrials.gov Identifier: NCT01293591     History of Changes
Other Study ID Numbers: Garlic Study 2010
Study First Received: February 8, 2011
Last Updated: February 9, 2011
Health Authority: United States: Federal Government

Keywords provided by USDA Beltsville Human Nutrition Research Center:
Garlic
Cancer biomarkers
Gene expression
Oxidative stress
DNA damage

ClinicalTrials.gov processed this record on August 20, 2014