NCT04753359Completed
Mediterranean Diet and Weight Loss: Targeting the Bile Acid/Gut Microbiome Axis to Reduce Colorectal Cancer
Source: ClinicalTrials.gov · Last updated 27 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 180 (actual)
- First submitted
- 29 Jan 2021
- Start date
- 1 Feb 2022
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- University of Illinois Chicago
- Diseases
- Colorectal cancer
- NCT number
- NCT04753359
What you commit to
- Study type: Interventional
- Participants enrolled: 180
- From 1 Feb 2022 to the primary completion date, 31 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- illicit drug abuse (other than marijuana based on self-report)
- currently on a WL diet or actively involved in a formal WL program (e.g., Weight Watchers)
Other illness
- renal disease
- autoimmune disorders
- malabsorptive disorders
- significant gastrointestinal and/or hepatic diseases
- severe ischemic heart disease
- severe pulmonary disease
- history of bariatric surgery
- eating disorder
- cancer treatment within the past 12 months
- history of CRC
- genetic predisposition to CRC (e.g., Lynch syndrome)
- food allergies that would interfere with adopting a MedDiet
- Gait disorder
- active Covid-19 infection within 6 weeks of recruitment/data collection.
Lab values
- uncontrolled diabetes based on HbA1c\>9.0%
Other
- immunodeficiency
- alcohol abuse (\> 50 grams/day)
- combustible tobacco use
- 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
- 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,
- currently pregnant
Who the study is looking for
- 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.
Age in the registry: 45 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Illinois at Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.