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Dietary Cysteine and Colorectal Cancer Risk

This study is looking at how different levels of cysteine in your diet might affect your gut health and inflammation, especially if you're between 45 and 75 years old and have a history of certain non-cancerous polyps. Researchers want to see if a Low Cysteine Diet (about 1.4 grams per 1000 calories) or a High Cysteine Diet (about 3 grams per 1000 calories) can change how your body processes cysteine, the types of bacteria in your gut, and levels of inflammation. The study aims to enroll 40 participants who identify as Black or Non-Hispanic White and have had three or more adenomatous polyps (a type of growth) or one larger than 1 cm in the past five years. The study's status is currently unclear.

Study design
This interventional study plans to enroll 40 participants to compare the effects of a Low Cysteine Diet versus a High Cysteine Diet.
What's involved
You would need to provide oral wash and stool samples, and complete 24-hour dietary records. Measurements of colonic inflammation, fecal microbial content, and systemic inflammation markers will be taken at multiple time points over 11 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 11 weeks, with measurements taken at various points until day 79.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07086833

The Food Environment, Microbial Cysteine Metabolism, and Cancer Disparities

Recruiting
NAAges 45–75InterventionalPrevention
Purdue University
~40 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:Low Cysteine DietHigh Cysteine Diet

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Colonic inflammation
Measured over Baseline, Week 1 (Day 8), Week 2 (Day 15), Week 4 (Day 29), Week 7 (Day 49), Week 8 (Day 57), Week 9 (Day 64), Week 11 (Day 78)
+2 more outcomes measured

Conditions

Colorectal Cancer

Explore related trials

Colorectal AdenomaColorectal Carcinoma

Where it's being run

2 sites across 1 states
Indiana2

Who to contact

Patricia G Wolf, PhD, RD
[email protected]
765-494-1860
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
Willingness to donate oral wash and stool samples
Willingness to complete 24-hour dietary recalls

Exclusion

Antibiotic use within the last 6 months
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

What this trial measures

  • Colonic inflammationBaseline, Week 1 (Day 8), Week 2 (Day 15), Week 4 (Day 29), Week 7 (Day 49), Week 8 (Day 57), Week 9 (Day 64), Week 11 (Day 78)

    Fecal calprotectin, a marker of intestinal inflammation, will be measured from 100 mg of stool collected at the respective timeframe using a CALPRO Calprotectin ELISA test.

  • Fecal microbial contentBaseline, Week 1 (Day 8), Week 2 (Day 15), Week 4 (Day 29), Week 7 (Day 49), Week 8 (Day 57), Week 9 (Day 64), Week 11 (Day 78)

    Microbial genomic DNA will be extracted from stool obtained at the respective timeframe using a Qiagen DNeasy PowerSoil Kit. Genomic DNA will be fragmented using a Covaris S2 and processed into libraries using an Integrated DNA Technologies xGen DNA Library Prep Kit. Final libraries will be pooled and sequenced on an Illumina NovaSeq X using 25B chemistry.

  • Systemic markers of inflammationBaseline, Week 1 (Day 9), Week 2 (Day 16), Week 3 (Day 23), Week 4 (Day 30), Week 7 (Day 50), Week 8 (Day 58), Week 9 (Day 65), Week 11 (Day 79)

    Serum from blood collected at the respective timeframe will be analyzed in triplicate with the Bio-Plex® Precision Pro™ (Bio rad, Hercules, CA) human cytokine 10-plex immunoassay to detect IL-1β, IL-6, IFN-γ, TNF-α, IL-2, IL-4, IL-5, IL-10, IL-12 (p70) and IL-13.