Mediterranean Diet and Weight Loss: Targeting the Bile Acid/Gut Microbiome Axis to Reduce Colorectal Cancer
- Conditions
- Diet HabitColorectal Cancer
- Registration Number
- NCT04753359
- Lead Sponsor
- University of Illinois at Chicago
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 232
Inclusion Criteria:<br><br> - Men and women 45-75 years of age<br><br> - Self-identify as AA<br><br> - BMI 30-50 kg/m2<br><br> - Willingness to participate in all procedures including maintaining weight/current<br> physical activity if randomized to Med-A/Control<br><br> - Willingness and ability to provide informed consent<br><br> - Willingness to be randomized<br><br> - Understands English<br><br> - Has access to a phone<br><br> - Plans to reside in Chicago for the next 8-10 months.<br><br>Exclusion Criteria:<br><br> - renal disease<br><br> - autoimmune disorders<br><br> - immunodeficiency<br><br> - malabsorptive disorders<br><br> - significant gastrointestinal and/or hepatic diseases<br><br> - severe ischemic heart disease<br><br> - severe pulmonary disease<br><br> - history of bariatric surgery<br><br> - alcohol abuse (> 50 grams/day)<br><br> - illicit drug abuse (other than marijuana based on self-report)<br><br> - combustible tobacco use<br><br> - uncontrolled diabetes based on HbA1c>9.0%<br><br> - eating disorder<br><br> - cancer treatment within the past 12 months<br><br> - history of CRC<br><br> - genetic predisposition to CRC (e.g., Lynch syndrome)<br><br> - weight > 450 lbs. (weight limitation of the DXA scanner)<br><br> - currently adhering to a MedDiet based on a diet screener<br><br> - self-reported WL > 3% in the past 12 months<br><br> - currently on a WL diet or actively involved in a formal WL program (e.g., Weight<br> Watchers)<br><br> - food allergies that would interfere with adopting a MedDiet<br><br> - antibiotic use in the past 3 months<br><br> - night-shift work<br><br> - regular use (i.e., = 3 times per week) of prebiotics/probiotics/synbiotics, dietary<br> fiber supplements, or laxatives,<br><br> - Gait disorder<br><br> - currently pregnant<br><br> - active Covid-19 infection within 6 weeks of recruitment/data collection.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Circulating and fecal bile acids;Circulating and fecal bile acids;Circulating and fecal bile acids;Gut microbiota for metabolic function;Gut microbiota for metabolic function;Gut microbiota for metabolic function;Gene expression;Gene expression;Gene expression;Exfoliated intestinal epithelial cell transcriptomics;Exfoliated intestinal epithelial cell transcriptomics;Exfoliated intestinal epithelial cell transcriptomics
- Secondary Outcome Measures
Name Time Method Body weight;Body weight;Body weight;Body mass index;Body mass index;Body mass index;Mediterranean Diet Adherence;Mediterranean Diet Adherence;Mediterranean Diet Adherence;Mediterranean Diet Adherance;Mediterranean Diet Adherence;Mediterranean Diet Adherence;Mediterranean Diet Adherence;Physical activity;Physical activity;Physical activity;Total and regional body composition (fat and muscle);Total and regional body composition (fat and muscle);Total and regional body composition (fat and muscle);Circulating cytokines;Circulating cytokines;Circulating cytokines;Fasting glucose;Fasting glucose;Fasting glucose;Fasting insulin;Fasting insulin;Fasting insulin