Reducing Metabolic Dysregulation in Dyads (NCT06117241)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of South Carolina — Columbia, South Carolina
Age range: 9 Years to 55 Years
🧪 Interventions in This Study
- IMAGINE HEALTHY (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University of South Carolina — Columbia, South Carolina
📞 Contact the Study Coordinator
Phone: (803) 576-5613
Email: jhebert@sc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Colorectal Cancer
- Impact of Colorectal Cancer and Nutrition Education Program Among Minority Patients With Type 2 Diabetes — Los Angeles, California
- A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors — Duarte, California
- Dose Escalation and Expansion Study of TROP2 CAR Engineered IL-15- Transduced Cord Blood-derived NK Cells in Combination With Cetuximab in Patient With Colorectal Cancer (CRC) With Minimal Residual Disease (MRD) — Houston, Texas
- Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combined With Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver — Basking Ridge, New Jersey
- The PRIME-CRC Trial to Promote CRC Screening in Rural Communities — Bastrop, Louisiana
- Radiation Therapy and Fluorouracil With or Without Combination Chemotherapy Followed by Surgery in Treating Patients With Stage II or Stage III Rectal Cancer — Concord, California
Explore by condition: All Colorectal Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.