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Inhibition of Fried Meat-Induced DNA Damage: A Dietary Intervention Study

18 Years
45 Years
Not Enrolling
Colon Cancer, Diet

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Trial Information

Inhibition of Fried Meat-Induced DNA Damage: A Dietary Intervention Study

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.

Inclusion Criteria


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


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.

Type of Study:


Study Design:


Principal Investigator

Jack Taylor, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute of Environmental Health Sciences (NIEHS)


United States: Federal Government

Study ID:




Start Date:

April 2004

Completion Date:

Related Keywords:

  • Colon Cancer
  • Diet
  • Heterocyclic Aminos
  • Cruciferous Vegetables
  • Yogurt
  • Chlorophyllin
  • Comet Assay
  • Diet
  • Healthy Volunteer
  • Colonic Neoplasms



NIEHS, Research Triangle Park Research Triangle Park, North Carolina  27709