RecruitingNot ApplicableNCT04753359

Mediterranean Diet and Weight Loss: Targeting the Bile Acid/Gut Microbiome Axis to Reduce Colorectal Cancer


Sponsor

University of Illinois at Chicago

Enrollment

232 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

A Mediterranean Diet (MedDiet), a largely plant-based dietary pattern, is relevant to CRC prevention and microbial production of anti-cancer metabolites in observational studies. A MedDiet can shift BA metabolism as shown in primates and when combined with calorie restriction, shows superior adherence and weight control in humans, given its palatability. To date, no studies have tested in an RCT the effects of a MedDiet alone (MedA), WL through lifestyle intervention (WL-A) or a calorie-restricted MedDiet for WL (WL-Med) on the BA-gut microbiome axis and its relevance to CRC prevention among AAs. A multidisciplinary team combining expertise in psychology, nutrition, microbiology, molecular cell biology, computational biology, medicine and biostatistics, proposes to conduct a four-arm RCT in which 232 obese AAs, 45-75 years old complete one of the following 6-month interventions: Med-A, weight stable; WL-A, calorie restriction with no diet pattern change; WLMed; or Control. The investigators will use samples and data collected at baseline, mid-study (month-3) and post-intervention to compare the effects of the interventions on 1) Concentration and composition of circulating and fecal BAs; 2) Gut microbiota and metabolic function; and 3) Gene expression profiles of exfoliated intestinal epithelial cells.


Eligibility

Min Age: 45 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a Mediterranean diet combined with weight loss can help reduce the risk of colorectal cancer by changing gut bacteria and bile acids. It is specifically focused on African American adults in Chicago. **You may be eligible if...** - You are a man or woman between 45 and 75 years old - You identify as African American - Your BMI is between 30 and 50 - You plan to stay in the Chicago area for the duration of the study - You have access to a phone and understand English **You may NOT be eligible if...** - You do not identify as African American - You are outside the age or BMI range - You do not live in the Chicago area Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERMed

Mediterranean diet

OTHERWL

Measuring change in weight


Locations(1)

University of Illinois at Chicago

Chicago, Illinois, United States

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NCT04753359


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