NCT00340743

Diet and Genetic Damage

Completed Last updated 18 July 2019

What this trial tests

trial in Diet in 16 participants. Completed in 16 July 2019.

Timeline

21 April 2004

16 July 2019

Quick facts

Lead sponsor	National Institute of Environmental Health Sciences (NIEHS)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	16
Start date	21 April 2004
Estimated completion	16 July 2019
Sites	1 location across United States

Conditions studied

• Diet — all drugs for Diet →

Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Who can join

Adults 18 to 45, any sex, with Diet. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Inhibition of fried meat-induced colorectal DNA damage and altered systemic genotoxicity in humans by crucifera, chlorophyllin, and yogurt.
   Shaughnessy DT, Gangarosa LM, Schliebe B, Umbach DM, et al · · 2011 · cited 38× · PMID 21541030 · DOI 10.1371/journal.pone.0018707