The Food Environment, Microbial Cysteine Metabolism, and Cancer Disparities
NCT ID: NCT07086833
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-07-30
2027-08-01
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
TRIPLE
Study Groups
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High cysteine diet
Participants will eat a diet higher in cysteine, relying on more animal based protein.
High Cysteine Diet
A diet high in cysteine, about 3 g/1000 kcal.
Low cysteine diet
Participants will eat a diet lower in cysteine, relying on more plant based protein.
Low Cysteine Diet
A diet low in cysteine, about 1.4 g/1000 kcal.
Interventions
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Low Cysteine Diet
A diet low in cysteine, about 1.4 g/1000 kcal.
High Cysteine Diet
A diet high in cysteine, about 3 g/1000 kcal.
Eligibility Criteria
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Inclusion Criteria
* 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
* Willingness to donate oral wash and stool samples
* Willingness to complete 24-hour dietary recalls
Exclusion Criteria
* Abnormal gastrointestinal transit
* A history of organ transplantation
* Use of illicit drugs, combustible tobacco, or dietary supplements
* Pre- or probiotics within the last two months
* A history of cancer treatment within the past 12 months
* CRC or a genetic predisposition to CRC
* A baseline body weight \> 450 lbs
* Weight gain or loss \> 4 kg 3 months prior to study
* Significant food allergies, food preferences or therapeutic or vegetarian diets
* Menstrual cycle within the last 6 months
* Antibiotics in the last 2 months
* Cannot keep a food record for 7 consecutive days during screening after detailed instruction
* Significant medical conditions
* History of eating disorders
* Alcoholism
* Individuals under the age of 18
45 Years
75 Years
ALL
No
Sponsors
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American Cancer Society, Inc.
OTHER
Indiana University
OTHER
Purdue University
OTHER
Responsible Party
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Patricia Wolf
Dr. Patricia Wolf, Assistant Professor, Department of Nutrition Science
Locations
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University Hospital Clinical Research Center
Indianapolis, Indiana, United States
Purdue Clinical Research Center
West Lafayette, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RSG-23-1154989-01-CSCT
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRB-2023-1426
Identifier Type: -
Identifier Source: org_study_id
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