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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
9 Years to 55 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This 6-month study tests whether diet changes can reduce long-term inflammation and improve how the body uses food for energy. It is for people with obesity who had at least one polyp (growth) found during a colon exam, along with an overweight partner who lives and eats with them.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • The main participant must identify as African American (AA) or European American (EA).
  • The main participant must be age 55 or younger.
  • The main participant must have obesity, with a body mass index (BMI) of 30 or higher. BMI is a measure based on height and weight.
  • The main participant must have had a colonoscopy (an exam inside the colon) that found at least one polyp linked to a higher risk of future growths and colon or rectal cancer.
  • The main participant must appear free of disease and have no health problems or other issues that would limit taking part.
  • The partner must be at least 9 years old and at least overweight.
  • The partner must live in the same home as the main participant and share meals with them.
  • Both must agree to all study steps, including assessments and body samples. The partner must also agree to body measurements and questions about diet and other topics.

Who can't join

  • Either person has used antibiotics within the past 3 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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).

Study sites (1)

SC