Diet and Genetic Damage

NCT00340743 | Completed

• 2 other identifiers: 99990416904-E-N169
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet

Keywords

Heterocyclic Aminos; Cruciferous Vegetables; Yogurt; Chlorophyllin; Comet Assay; Diet; Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• to determine if eating certain foods and other dietary constituents will ameliorate the short-term damaging effects associated with fried meat consumption.

  Continuously

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

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.

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599-7030, United States

Location

Related Publications (4)

• Butler LM, Sinha R, Millikan RC, Martin CF, Newman B, Gammon MD, Ammerman AS, Sandler RS. Heterocyclic amines, meat intake, and association with colon cancer in a population-based study. Am J Epidemiol. 2003 Mar 1;157(5):434-45. doi: 10.1093/aje/kwf221.

  PMID: 12615608 BACKGROUND

• Baker R, Arlauskas A, Bonin A, Angus D. Detection of mutagenic activity in human urine following fried pork or bacon meals. Cancer Lett. 1982 May-Jun;16(1):81-9. doi: 10.1016/0304-3835(82)90094-5.

  PMID: 6811131 BACKGROUND

• DeMarini DM, Hastings SB, Brooks LR, Eischen BT, Bell DA, Watson MA, Felton JS, Sandler R, Kohlmeier L. Pilot study of free and conjugated urinary mutagenicity during consumption of pan-fried meats: possible modulation by cruciferous vegetables, glutathione S-transferase-M1, and N-acetyltransferase-2. Mutat Res. 1997 Nov 19;381(1):83-96. doi: 10.1016/s0027-5107(97)00152-8.

  PMID: 9403034 BACKGROUND

• Shaughnessy DT, Gangarosa LM, Schliebe B, Umbach DM, Xu Z, MacIntosh B, Knize MG, Matthews PP, Swank AE, Sandler RS, DeMarini DM, Taylor JA. Inhibition of fried meat-induced colorectal DNA damage and altered systemic genotoxicity in humans by crucifera, chlorophyllin, and yogurt. PLoS One. 2011 Apr 25;6(4):e18707. doi: 10.1371/journal.pone.0018707.

  PMID: 21541030 DERIVED

Study Officials

• Jack Taylor, M.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: April 21, 2004
• Study Completion: July 16, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07-16

Locations

US (1)