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Diet and weight loss may cut colon cancer risk, study finds

NCT ID NCT04753359

Prevention Sponsor: University of Illinois at Chicago Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a Mediterranean diet, weight loss, or both could lower colorectal cancer risk in 180 obese African Americans aged 45-75. Participants followed one of four plans for six months, and researchers measured changes in bile acids, gut bacteria, and cell activity linked to cancer. The goal was to see if these lifestyle changes could help prevent the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

180 people

The number who actually took part.

Started

Feb 2022

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Men and women 45-75 years of age * Self-identify as AA * BMI 30-50 kg/m2 * Willingness to participate in all procedures including maintaining weight/current physical activity if randomized to Med-A/Control * Willingness and ability to provide informed consent * Willingness to be randomized * Understands English * Has access to a phone * Plans to reside in Chicago for the next 8-10 months. Exclusion Criteria: * renal disease * autoimmune disorders * immunodeficiency * malabsorptive disorders * significant gastrointestinal and/or hepatic diseases * severe ischemic heart disease * severe pulmonary disease * history of bariatric surgery * alcohol abuse (\> 50 grams/day) * illicit drug abuse (other than marijuana based on self-report) * combustible tobacco use * uncontrolled diabetes based on HbA1c\>9.0% * eating disorder * cancer treatment within the past 12 months * history of CRC * genetic predisposition to CRC (e.g., Lynch syndrome) * weight \> 450 lbs. (weight limitation of the DXA scanner) * currently adhering to a MedDiet based on a diet screener * self-reported WL \> 3% in the past 12 months * currently on a WL diet or actively involved in a formal WL program (e.g., Weight Watchers) * food allergies that would interfere with adopting a MedDiet * antibiotic use in the past 3 months * night-shift work * regular use (i.e., ≥ 3 times per week) of prebiotics/probiotics/synbiotics, dietary fiber supplements, or laxatives, * Gait disorder * currently pregnant * active Covid-19 infection within 6 weeks of recruitment/data collection.

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Conditions

The condition(s) this trial relates to.

colorectal neoplasm Feeding Behavior obesity disorder colorectal cancer prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer Diet habit

Contacts and locations

Locations

  • University of Illinois at Chicago

    Chicago, Illinois, 60612, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.