Garlic Intake And Biomarkers Of Cancer Risk

NCT01293591 | Completed

• 1 other identifier: Garlic Study 2010
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Men; Healthy Women

Keywords

Garlic; Cancer biomarkers; Gene expression; Oxidative stress; DNA damage

Outcome Measures

Primary Outcomes (5)

• Garlic metabolites

  Garlic metabolites will be measured in blood and urine.

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

• 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

• DNA damage

  Comet assay, 8-oxo-dG, histone analysis

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

• 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

• Biomarkers of inflammation

  C-reactive protein (CRP), vascular endothelial growth factor, IL-1, IL-6, TNF-α.

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

Study Arms (2)

Control

OTHER

270 kcal White bread with 15 g margarine

Other: Control

Garlic Treatment

OTHER

270 kcal white bread with 15 g margarine and 5 g crushed garlic

Other: Garlic treatment

Interventions

Control OTHER

Subjects will consume a garlic-free diet for 10 days. On day 11, subjects will consume 270 kcal white bread with 15 g margarine.

Control

Garlic treatment OTHER

Subjects will consume a garlic-free diet for 10 days. On day 11, subjects will consume 270 kcal white bread with 15 g margarine and 5 g crushed garlic.

Garlic Treatment

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-80 years

You may not qualify if:

• 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

Sponsors & Collaborators

• USDA Beltsville Human Nutrition Research Center: lead

Study Sites (1)

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Related Publications (1)

• Charron CS, Dawson HD, Albaugh GP, Solverson PM, Vinyard BT, Solano-Aguilar GI, Molokin A, Novotny JA. A Single Meal Containing Raw, Crushed Garlic Influences Expression of Immunity- and Cancer-Related Genes in Whole Blood of Humans. J Nutr. 2015 Nov;145(11):2448-55. doi: 10.3945/jn.115.215392. Epub 2015 Sep 30.

  PMID: 26423732 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Physiologist

Study Record Dates

• First Submitted: February 8, 2011
• First Posted: February 10, 2011
• Study Start: July 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: June 2, 2017

Record last verified: 2011-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)