Actively Recruiting

Phase Not Applicable
Age: 45Years - 75Years
All Genders
Healthy Volunteers
NCT04753359

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

Led by University of Illinois at Chicago · Updated on 2024-08-21

232

Participants Needed

1

Research Sites

164 weeks

Total Duration

On this page

Sponsors

U

University of Illinois at Chicago

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 45Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women 45-75 years of age
  • Self-identify as African American
  • Body mass index (BMI) between 30 and 50 kg/m2
  • Willing to participate in all study procedures including maintaining weight and current physical activity if assigned to Mediterranean diet or control
  • Willing and able to provide informed consent
  • Willing to be randomly assigned to a study group
  • Understands English
  • Has access to a phone
  • Plans to live in Chicago for the next 8 to 10 months
Not Eligible

You will not qualify if you...

  • Renal disease
  • Autoimmune disorders
  • Immunodeficiency
  • Malabsorptive disorders
  • Significant gastrointestinal or liver diseases
  • Severe ischemic heart disease
  • Severe lung disease
  • History of bariatric surgery
  • Alcohol abuse (more than 50 grams per day)
  • Illicit drug use (except self-reported marijuana)
  • Use of combustible tobacco
  • Uncontrolled diabetes with HbA1c over 9.0%
  • Eating disorder
  • Cancer treatment within the past 12 months
  • History of colorectal cancer
  • Genetic risk for colorectal cancer (e.g., Lynch syndrome)
  • Weight over 450 pounds (due to scanner limits)
  • Currently following a Mediterranean diet
  • Weight loss greater than 3% in the past 12 months
  • Currently on a weight loss diet or program
  • Food allergies that prevent following a Mediterranean diet
  • Antibiotic use in the past 3 months
  • Night-shift work
  • Regular use (3 or more times per week) of prebiotics, probiotics, synbiotics, fiber supplements, or laxatives
  • Gait disorder
  • Currently pregnant
  • Active COVID-19 infection within 6 weeks of recruitment or data collection

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Illinois at Chicago

Chicago, Illinois, United States, 60612

Actively Recruiting

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Research Team

L

Lara Blumstein

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

4

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