New treatment option for Colorectal Cancer
Official title The Food Environment, Microbial Cysteine Metabolism, and Cancer Disparities
ClinicalTrials.gov ID: NCT07086833
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 75
You may be able to join if
- 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...
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
- West Lafayette, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States; West Lafayette, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.