Diet Change for Metabolic Dysfunction in Colorectal Polyp Patients (REMEDY Trial)

N/A

Recruiting

Research Sponsored by University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≤55 years old

Agreed to undergo colonoscopy screening and found to have ≥1 polyp(s) that place them at elevated risk for future adenomas and CRC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3-month, 6-month

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a diet change can reduce chronic inflammation and reverse metabolic dysfunction in obese people with polyps. A partner who is at least overweight is also required. Eligibility includes being ≤55, BMI ≥30kg/m2 and no recent antibiotic use.

Who is the study for?

This trial is for disease-free, obese African Americans or European Americans under 55 years old with at least one polyp found during colonoscopy. They must have a BMI of ≥30kg/m2 and a partner who is at least overweight and shares meals with them. Both should not have used antibiotics recently.

What is being tested?

The 'IMAGINE HEALTHY' program focuses on diet modification to reduce inflammation and reverse metabolic dysfunction in obese individuals with colorectal polyps and their overweight partners over a period of six months.

What are the potential side effects?

Since this study involves dietary changes rather than medication, side effects may include gastrointestinal discomfort due to new foods or eating patterns but are generally expected to be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 55 years old or younger.

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I have polyps found during a colonoscopy that increase my risk for future cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3-month, 6-month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3-month, 6-month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3-month, 6-month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood

Stool

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Participation will be for six months. Participants will meet staff at three timepoints (baseline, 3 months, 6 months) to complete questionnaires, online dietary assessment, body measures, have blood pressure measured, provide blood and stool samples, and wear an activity monitor for a week at each time point. In addition, participants will attend weekly classes for 12 weeks and one class per month for three months. These classes will include cooking, movement, and stress reduction.

Group II: ComparisonActive Control1 Intervention

0 / 2Eligibility criteria met