Actively Recruiting

Phase Not Applicable
Age: 45Years - 75Years
All Genders
NCT07086833

The Food Environment, Microbial Cysteine Metabolism, and Cancer Disparities

Led by Purdue University · Updated on 2026-05-14

40

Participants Needed

2

Research Sites

119 weeks

Total Duration

On this page

Sponsors

P

Purdue University

Lead Sponsor

A

American Cancer Society, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

The Food Environment, Microbial Cysteine Metabolism, and Cancer Disparities

Who Can Participate

Age: 45Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 45 to 75 years
  • Up to date with colorectal cancer screening colonoscopy and at high risk for colorectal cancer, defined as a history of 3 or more adenomatous polyps or an adenomatous polyp larger than 1 cm in the past 5 years
  • Identify as Black or Non-Hispanic White
  • If female, no menstrual period for at least six months
  • Willingness to provide oral wash and stool samples
  • Willingness to complete 24-hour dietary recalls
Not Eligible

You will not qualify if you...

  • Antibiotic use within the last 6 months
  • Abnormal gastrointestinal transit
  • History of organ transplantation
  • Use of illicit drugs, combustible tobacco, or dietary supplements
  • Use of pre- or probiotics within the last two months
  • History of cancer treatment within the past 12 months
  • Diagnosis of colorectal cancer or genetic predisposition to colorectal cancer
  • Baseline body weight over 450 pounds
  • Weight gain or loss greater than 4 kg within 3 months prior to study
  • Significant food allergies, food preferences, or special therapeutic or vegetarian diets
  • Menstrual cycle within the last 6 months
  • Antibiotic use within the last 2 months
  • Unable to keep a food record for 7 consecutive days during screening after instruction
  • Significant medical conditions
  • History of eating disorders
  • Alcoholism
  • Individuals under 18 years of age

AI-Screening

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Trial Site Locations

Total: 2 locations

1

University Hospital Clinical Research Center

Indianapolis, Indiana, United States, 46202

Not Yet Recruiting

2

Purdue Clinical Research Center

West Lafayette, Indiana, United States, 47906

Actively Recruiting

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Research Team

P

Patricia G Wolf, PhD, RD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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