RecruitingNot ApplicableNCT06117241

Reducing Metabolic Dysregulation in Dyads

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


Sponsor

University of South Carolina

Enrollment

180 participants

Start Date

Oct 17, 2023

Study Type

INTERVENTIONAL

Conditions

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 at a colonoscopy screening. We also will recruit an at least overweight partner, who lives in the same household. To be eligible, participants will be apparently disease-free, obese AAs or EAs who have self-identified a partner who is at least 9 years, with whom they live and who also is at least overweight. Each index participant will: 1) Be AA or EA by self-report; 2) Be ≤55 years old; 3) Have undergone a colonoscopy screening and found to have ≥1 polyp(s); 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. Their 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, body measurements, and self-reported dietary and other assessments; and 5) Have no recent antibiotic use.


Eligibility

Min Age: 9 YearsMax Age: 55 Years

Inclusion Criteria1

  • 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).

Interventions

BEHAVIORALIMAGINE HEALTHY

An anti-inflammatory nutrition program including cooking classes, physical activity, and stress reduction.


Locations(1)

University of South Carolina

Columbia, South Carolina, United States

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NCT06117241


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