The Food Environment, Microbial Cysteine Metabolism, and Cancer Disparities

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorPurdue University

About this trial

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 criteria

Qualifiers

Aged 45-75

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

Identify as Black or Non-Hispanic White

If female, no menstrual period for at least six months

Disqualifiers

Antibiotic use within the last 6 months

Abnormal gastrointestinal transit

A history of organ transplantation

Use of illicit drugs, combustible tobacco, or dietary supplements

Trial design

Treatments tested in this trial

  • Low Cysteine Diet
  • High Cysteine Diet

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Purdue University

Lead sponsor

American Cancer Society, Inc.

Collaborator

Indiana University

Collaborator