Diet and Genetic Damage

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00340743
First received: June 19, 2006
Last updated: March 14, 2014
Last verified: October 2013
  Purpose

This study will examine the risks and protective effects of dietary factors on temporary genetic damage to cells lining the gastrointestinal tract and to blood cells. Some foods, including very well done meat, may increase genetic damage in cells, while others, such as yogurt and vegetables, may reduce genetic damage. This study may provide new information on the influence of diet on increasing or decreasing the risk of developing cancer, particularly colorectal cancer. The study is conducted at the General Clinical Research Center (GCRC) of the University of North Carolina.

Nonsmoking, English-speaking, healthy adults between 18 and 45 years of age may be eligible for this 4-week study. Participants undergo the following tests and procedures:

  • Interview: Participants complete questionnaires including information on their diets, habits, past and present health, and family histories.
  • Diet: Participants adhere strictly to the diet provided by the dietician at the GCRC for all 4 weeks of the study. All meals are provided by the GCRC. All meals contain well-done meat and some contain yogurt, cruciferous vegetables, including broccoli and cabbage, and chlorophyllin tablets. Chlorophyllin is a compound in some foods that protects against genetic damage.
  • Urine sampling: Participants collect a urine sample each morning except Saturday and Sunday.
  • Stool sampling: Participants collect two stool samples during the study, one during the second week and another during the fourth week.
  • Blood draw: About 2-1/2 tablespoons of blood are drawn once a week for research purposes. The blood is tested for the effects of eating foods in the different diets used in the study.
  • Rectal biopsies: Four pinch biopsies, each about the size of a grain of rice, are taken from the rectum once a week for research purposes. For this procedure, forceps are inserted shallowly into the rectum to collect the tissue. The effects of the different diets on the colon cells are measured.

Condition
Colon Cancer
Diet

Study Type: Observational
Official Title: Inhibition of Fried Meat-Induced DNA Damage: A Dietary Intervention Study

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 16
Study Start Date: April 2004
Detailed Description:

Dietary exposures have been implicated as risk factors in colorectal cancer. Such agents may act by causing DNA damage or may be protective against DNA damage. The effect of dietary exposures in either causing or preventing damage has not been directly assessed in colon tissues. We are proposing a pilot study of dietary factors and DNA damage, involving 16 healthy volunteers in a four-week controlled feeding study. The primary focus of this study is to assess genetic damage to colonic epithelium and blood lymphocytes induced by pyrolysis products formed in cooked meat, as well as the putative protective effects of cruciferous vegetables, yogurt, and chlorophyllin against that damage. In the first phase of this pilot study, eight subjects will be fed either a baseline diet or a diet high in fried meat in two-week intervals. In the second phase, the remaining eight subjects will be fed either the fried meat diet or a diet containing fried meat along with putative inhibitors. In both phases of the study, blood will be drawn and rectal biopsies will be obtained from subjects each week during the four-week study periods. Damage in the lymphocytes and colon epithelium from the different dietary regimens will be evaluated using the single cell gel electrophoresis (comet) assay. Rectal biopsies used in this study are painless and generally without risk. In previous studies conducted by Dr. Robert Sandler, at UNC, over 2,000 rectal biopsies have been obtained without any adverse events. The goal of this study will be to determine the feasibility of conducting a larger study to examine the interaction of genotoxic components in fried meat with "protective" dietary factors on a molecular level.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Nonsmoking, English speaking, healthy adults, ages 18-45 will be enrolled.

EXCLUSION CRITERIA:

Pregnant women will be excluded, as the dietary regimen in this study is not optimal for pregnant women.

Individuals will also be excluded if they consume more than two alcoholic drinks per day, have a history of illicit drug use, have a history of goiter, diabetes, colitis, or a diagnosed current thyroid condition, are excessively obese (BMI greater than 30), are vegetarians, or are currently taking anti-coagulant medication.

Individuals on prescription medications or antibiotics will be excluded.

Consumption of tea, or use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), or vitamin or herbal supplements by participants will also be prohibited during the study.

Alcohol consumption will be prohibited during the study.

Children will not be enrolled in the study.

  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: NCT00340743

Locations
United States, North Carolina
NIEHS, Research Triangle Park
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
Investigators
Principal Investigator: Jack Taylor, M.D. National Institute of Environmental Health Sciences (NIEHS)
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00340743     History of Changes
Other Study ID Numbers: 999904169, 04-E-N169
Study First Received: June 19, 2006
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Heterocyclic Aminos
Cruciferous Vegetables
Yogurt
Chlorophyllin
Comet Assay
Diet
Healthy Volunteer

ClinicalTrials.gov processed this record on September 30, 2014