Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340743
Status:
COMPLETED
Last Update Posted:
2019-07-18
First Post:
2006-06-19
Brief Title:
Diet and Genetic Damage
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Inhibition of Fried Meat-Induced DNA Damage A Dietary Intervention Study
Status:
COMPLETED
Status Verified Date:
2019-07-16
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 2-12 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
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 2-12 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-E-N169 | None | None | None |