RecruitingNot ApplicableNCT07086833

The Food Environment, Microbial Cysteine Metabolism, and Cancer Disparities


Sponsor

Purdue University

Enrollment

40 participants

Start Date

Jul 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 45 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how diet and gut bacteria — specifically how gut microbes process the amino acid cysteine — may explain why Black Americans are at higher risk of colorectal cancer (bowel cancer) compared to non-Hispanic white Americans. Participants provide dietary information and stool samples. **You may be eligible if...** - You are between 45 and 75 years old - You have had a colonoscopy showing high risk for colorectal cancer (3 or more adenomatous polyps, or a polyp larger than 1 cm, in the last 5 years) - You identify as Black or Non-Hispanic White - If female, you have not had a menstrual period in at least 6 months - You are willing to donate stool and oral wash samples and complete diet recall surveys **You may NOT be eligible if...** - You used antibiotics in the last 6 months - You have abnormal bowel function, a history of organ transplant, or cancer treatment in the last 5 years - You currently use combustible tobacco, illicit drugs, or dietary supplements - You have used probiotics or prebiotics in the last 2 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERLow Cysteine Diet

A diet low in cysteine, about 1.4 g/1000 kcal.

OTHERHigh Cysteine Diet

A diet high in cysteine, about 3 g/1000 kcal.


Locations(2)

University Hospital Clinical Research Center

Indianapolis, Indiana, United States

Purdue Clinical Research Center

West Lafayette, Indiana, United States

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NCT07086833


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