RECRUITING

The Food Environment, Microbial Cysteine Metabolism, and Cancer Disparities

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn if changing cysteine levels in the diet can influence how the body processes cysteine in Black and White individuals aged 45-75 with a history of non-cancerous polyps. The main questions it aims to answer are: * At the beginning of the study, do Black participants have higher levels of cortisol (a stress hormone) and compounds made from cysteine in their blood when compared to White participants? * Does eating less cysteine lower the body's natural cysteine activity and lead to less gut bacteria that break down cysteine? * Does eating less cysteine lead to less inflammation in the gut and lower levels of markers of inflammation in the blood? Research will compare a high cysteine diet and a low cysteine diet, and each participant will eat both diets. Participants will be in the study for 11 weeks and 2 days. Over the course of the study, participants will: * Eat a high cysteine diet for 3 weeks, and a low cysteine diet for 3 weeks * Eat a moderate cysteine diet for 1 week before each study diet * Complete surveys * Provide blood, stool, and saliva samples * Maintain food logs

Official Title

The Food Environment, Microbial Cysteine Metabolism, and Cancer Disparities

Quick Facts

Study Start:2025-07-30
Study Completion:2027-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07086833

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 45-75
  2. * Up to date with CRC screening colonoscopy with a high risk of CRC, defined as a history of 3 or more adenomatous polyps (APs) or an AP \>1 cm in the past 5 years
  3. * Identify as Black or Non-Hispanic White
  4. * If female, no menstrual period for at least six months
  5. * Willingness to donate oral wash and stool samples
  6. * Willingness to complete 24-hour dietary recalls
  1. * Antibiotic use within the last 6 months
  2. * Abnormal gastrointestinal transit
  3. * A history of organ transplantation
  4. * Use of illicit drugs, combustible tobacco, or dietary supplements
  5. * Pre- or probiotics within the last two months
  6. * A history of cancer treatment within the past 12 months
  7. * CRC or a genetic predisposition to CRC
  8. * A baseline body weight \> 450 lbs
  9. * Weight gain or loss \> 4 kg 3 months prior to study
  10. * Significant food allergies, food preferences or therapeutic or vegetarian diets
  11. * Menstrual cycle within the last 6 months
  12. * Antibiotics in the last 2 months
  13. * Cannot keep a food record for 7 consecutive days during screening after detailed instruction
  14. * Significant medical conditions
  15. * History of eating disorders
  16. * Alcoholism
  17. * Individuals under the age of 18

Contacts and Locations

Study Contact

Patricia G Wolf, PhD, RD
CONTACT
765-494-1860
wolfpm@purdue.edu

Study Locations (Sites)

University Hospital Clinical Research Center
Indianapolis, Indiana, 46202
United States
Purdue Clinical Research Center
West Lafayette, Indiana, 47906
United States

Collaborators and Investigators

Sponsor: Purdue University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-30
Study Completion Date2027-08-01

Study Record Updates

Study Start Date2025-07-30
Study Completion Date2027-08-01

Terms related to this study

Keywords Provided by Researchers

  • Intestinal Neoplasms
  • Neoplasms
  • Colonic Diseases
  • Colorectal Cancer
  • Colorectal Neoplasms
  • Gut Microbiome
  • Cysteine Metabolism
  • Colorectal Adenomas
  • Intestinal Diseases

Additional Relevant MeSH Terms

  • Colorectal Cancer Risk
  • Colorectal Cancer Prevention
  • Colorectal Cancer
  • Diet Modification
  • Dietary Intervention
  • Cancer Prevention