Actively Recruiting

Phase Not Applicable
Age: 9Years - 55Years
All Genders
Healthy Volunteers
NCT06117241

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

Age: 9Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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)
Not Eligible

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

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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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