Diet and Genetic Damage
Completed
Conditions studied: Diet
In brief
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.
Key facts
- Study ID
- NCT00340743
- Run by
- National Institute of Environmental Health Sciences (NIEHS)
- People needed
- 16
- Starts
- 2004-04-21
- Expected to finish
- 2019-07-16
- Last updated by the study team
- 2019-07-18
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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.
Where it is running
- University of North Carolina — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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