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

Launched by UNIVERSITY OF ILLINOIS AT CHICAGO · Feb 10, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of different dietary approaches on weight loss and colorectal cancer prevention in African American adults. Researchers want to understand how a Mediterranean Diet, which is rich in fruits, vegetables, and healthy fats, compares to other weight-loss methods. Participants will be divided into four groups for six months: one group will follow the Mediterranean Diet without changing their weight, another will focus on losing weight without changing their diet, a third group will follow a calorie-restricted Mediterranean Diet, and the last group will not make any dietary changes. The trial aims to see how these diets affect gut health and other factors related to cancer risk.

To be eligible for the study, participants should be between 45 and 75 years old, identify as African American, and have a body mass index (BMI) between 30 and 50, which indicates obesity. They must also be willing to commit to the study procedures and live in the Chicago area for the duration of the trial. Participants can expect to provide health information and samples at the beginning, halfway through, and at the end of the study. This research could help improve dietary recommendations for cancer prevention and weight management in the African American community.

Gender

ALL

Eligibility criteria

• 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.