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Diet and Genetic Damage

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ClinicalTrials.gov Identifier: NCT00340743
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : July 18, 2019
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )

Tracking Information
First Submitted Date June 19, 2006
First Posted Date June 21, 2006
Last Update Posted Date July 18, 2019
Study Start Date April 21, 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: October 28, 2014)
to determine if eating certain foods and other dietary constituents will ameliorate the short-term damaging effects associated with fried meat consumption. [ Time Frame: Continuously ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Diet and Genetic Damage
Official Title Inhibition of Fried Meat-Induced DNA Damage: A Dietary Intervention Study
Brief Summary

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.
Detailed Description Colorectal cancer is one of the most common forms of cancer worldwide and is the second leading cause of cancer death in the United States. Given the frequency of occurrence and the poor prognosis for many afflicted individuals, prevention of this disease has been a major public health priority for the past few decades. However evidence from epidemiological studies has yet to explain the tremendous excess risk in developed countries, a trend that has been tentatively attributed to lifestyle and dietary factors. In the past few years, the consumption of red meat in particular, and other meat products, has attracted considerable attention in epidemiological, clinical, and experimental studies, with an increasing focus on a certain class of compounds found in cooked meat, heterocyclic amines. Heterocyclic amines are substances formed through pyrolysis of amino acids and creatine when meats are cooked at high temperature, particularly by pan-frying. Heterocyclic amine levels increase with cooking temperature, with the type and shape of the cooked piece of meat, with the degree of browning on the surface, and with the cooking method. In several epidemiological studies, including studies from Harvard, the International Agency for Research on Cancer (IARC), and the National Cancer Institute (NCI), individuals with long-term exposure to heterocyclic amines in their diet had an increased risk of colorectal cancers and colorectal adenomas, respectively. However, not all studies of heterocyclic amines in humans have shown a positive association with colorectal cancer risk, and clear consensus regarding this association is lacking. Based on the implications from these epidemiological studies, researchers at NCI have recently conducted a series of controlled feeding studies aimed at relating short-term exposure to heterocyclic amines through fried meat consumption to transient changes in urine mutagenicity levels. These studies provide evidence that meat fried at high temperatures results in significant short-term increases in exposure to mutagens. However, whereas urine mutagenicity appears to be a good short-term measure of exposure to heterocyclic amines in the diet, it is unclear as to whether these compounds induce genetic damage in colonic epithelial cells in humans. Against this background, we propose conducting a feeding study that includes the examination of colon tissue for evidence of transient DNA damage detected in the single cell gel electrophoresis (comet) assay following experimental intake of fried meat. This study will provide more direct evidence than previous studies as to whether genetic damage in colon epithelium and lymphocytes is related to dietary intake of heterocyclic amines. The use of the comet assay to detect the effects of diet on transient DNA damage is novel in this type of controlled feeding study, particularly with respect to monitoring effects of diet on colon epithelial cells. We will also monitor effects of fried meat ingestion on DNA damage in lymphocytes and detect changes in urinary mutagenicity related to these dietary regimens.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Diet
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 19, 2006)
Original Enrollment Same as current
Study Completion Date July 16, 2019
Primary Completion Date Not Provided
Eligibility 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.

Sexes Eligible for Study: All
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT00340743
Other Study ID Numbers 999904169
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )
Original Responsible Party Not Provided
Current Study Sponsor National Institute of Environmental Health Sciences (NIEHS)
Original Study Sponsor Same as current
Collaborators Not Provided
Principal Investigator: Jack Taylor, M.D. National Institute of Environmental Health Sciences (NIEHS)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date July 16, 2019