Status:
RECRUITING
Mediterranean Diet and Weight Loss: Targeting the Bile Acid/Gut Microbiome Axis to Reduce Colorectal Cancer
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Diet Habit
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief 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 B...
Detailed Description
Colorectal cancer (CRC) is associated with multiple risk factors including, obesity, low fiber diets, and diets high in animal protein and saturated fat (SFat). African Americans (AAs) have a higher p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT04753359
Start Date
February 1 2022
End Date
March 31 2025
Last Update
August 21 2024
Active Locations (1)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612