Diet modification to reduce inflammation and metabolic dysfunction in obese individuals with polyps
A Transdisciplinary Approach to Investigating Metabolic and Risk of Early-Onset Colorectal Cancer: A Randomized Intervention Trial in Human Dyads and Mechanistic Study in Animals
This study is testing whether changing the diet of obese people with polyps can help reduce inflammation and improve their health over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 9 Years to 55 Years |
| Sex | All |
| Sponsor | University of South Carolina Academic / other |
| Locations | 1 site (Columbia, South Carolina) |
| Trial ID | NCT06117241 on ClinicalTrials.gov |
What this trial studies
This study is a 6-month randomized controlled trial aimed at modifying diet to reduce chronic inflammation and reverse metabolic dysfunction in obese individuals who have been found to have polyps during colonoscopy screenings. Participants will include obese African American or European American individuals and their overweight partners living in the same household. The trial will focus on dietary modulation of gut microbes to prevent early-onset colorectal cancer by addressing the interaction between diet and adiposity. The study will also include a complementary mechanistic animal study to further explore the effects of diet on obesity and colorectal cancer.
Who should consider this trial
Good fit: Ideal candidates are obese individuals aged 55 or younger with at least one polyp found during a colonoscopy, who can identify an overweight partner living in the same household.
Not a fit: Patients who are not obese, do not have polyps, or have significant co-morbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to effective dietary interventions that reduce the risk of colorectal cancer in at-risk populations.
How similar studies have performed: While there is a growing interest in dietary interventions for colorectal cancer prevention, this specific approach targeting early-onset colorectal cancer through lifestyle changes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Individuals eligible to participate in this study will be apparently disease- free, obese (BMI ≥ 30kg/m2) AAs or EAs who have self-identified a partner who is at least 9 years old, with whom they live and who also is at least overweight. Each index patient will: 1) Be AA or EA by self-report; 2) Be ≤55 years old; 3) Have agreed to undergo colonoscopy screening and found to have ≥1 polyp(s) that place them at elevated risk for future adenomas and CRC; 4) Be free of co-morbid conditions or other factors that would limit participation in this trial; 5) Have a BMI ≥30kg/m2; 6) Be willing to commit to investing the time and effort required to participate in this trial (i.e., willing to complete all assessments and provide biological samples as specified in the consent); and 7) Have no recent antibiotic use (≤3 months). Their dyad partner needs to: 1) Be at least 9 years old; 2) Live in the same household and consumes meals together; 3) Be at least overweight; 4) Agree to all study procedures, including provision of biological samples, anthropometric measurements, and self-reported dietary and other assessments; 5) Have no recent antibiotic use (≤3 months).
Where this trial is running
Columbia, South Carolina
- University of South Carolina — Columbia, South Carolina, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.