Actively Recruiting
Reducing Metabolic Dysregulation in Dyads
Led by University of South Carolina · Updated on 2026-01-29
180
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Reducing Metabolic Dysregulation in Dyads
Who Can Participate
Eligibility Criteria
You may qualify if you...
- African-American or European-American by self-report
- Age 18 to 55 years
- Underwent colonoscopy screening with one or more polyps found
- Obese with a BMI of 30 kg/m2 or higher
- Apparently disease-free without co-morbid conditions limiting participation
- Willing to complete all assessments and provide biological samples
- No recent antibiotic use (within the past 3 months)
- Has a partner at least 9 years old who lives in the same household and is at least overweight
- Partner agrees to study procedures including biological sample collection and dietary assessments
- Partner has no recent antibiotic use (within the past 3 months)
You will not qualify if you...
- Presence of co-morbid conditions or other factors limiting trial participation
- Recent antibiotic use within the past 3 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of South Carolina
Columbia, South Carolina, United States, 29208
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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