Status:
RECRUITING
Reducing Metabolic Dysregulation in Dyads
Lead Sponsor:
University of South Carolina
Conditions:
Colorectal Cancer
Inflammation
Eligibility:
All Genders
9-55 years
Phase:
NA
Brief Summary
This study is a 6-month randomized controlled trail of diet modification designed to reduce chronic inflammation and reverse metabolic dysfunction among obese individuals with one or more polyps found...
Detailed Description
This project leverages our expertise in the epidemiology of colorectal cancer (CRC); disparities; obesity; metabolic dysregulation, an important manifestation of inflammation; the microbiome; animal C...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
October 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06117241
Start Date
October 17 2023
End Date
March 31 2028
Last Update
April 10 2025
Active Locations (1)
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1
University of South Carolina
Columbia, South Carolina, United States, 29208