RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-02-01
Study Completion:2025-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04753359

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women 45-75 years of age
  2. * Self-identify as AA
  3. * BMI 30-50 kg/m2
  4. * Willingness to participate in all procedures including maintaining weight/current physical activity if randomized to Med-A/Control
  5. * Willingness and ability to provide informed consent
  6. * Willingness to be randomized
  7. * Understands English
  8. * Has access to a phone
  9. * Plans to reside in Chicago for the next 8-10 months.
  1. * renal disease
  2. * autoimmune disorders
  3. * immunodeficiency
  4. * malabsorptive disorders
  5. * significant gastrointestinal and/or hepatic diseases
  6. * severe ischemic heart disease
  7. * severe pulmonary disease
  8. * history of bariatric surgery
  9. * alcohol abuse (\> 50 grams/day)
  10. * illicit drug abuse (other than marijuana based on self-report)
  11. * combustible tobacco use
  12. * uncontrolled diabetes based on HbA1c\>9.0%
  13. * eating disorder
  14. * cancer treatment within the past 12 months
  15. * history of CRC
  16. * genetic predisposition to CRC (e.g., Lynch syndrome)
  17. * weight \> 450 lbs. (weight limitation of the DXA scanner)
  18. * currently adhering to a MedDiet based on a diet screener
  19. * self-reported WL \> 3% in the past 12 months
  20. * currently on a WL diet or actively involved in a formal WL program (e.g., Weight Watchers)
  21. * food allergies that would interfere with adopting a MedDiet
  22. * antibiotic use in the past 3 months
  23. * night-shift work
  24. * regular use (i.e., ≥ 3 times per week) of prebiotics/probiotics/synbiotics, dietary fiber supplements, or laxatives,
  25. * Gait disorder
  26. * currently pregnant
  27. * active Covid-19 infection within 6 weeks of recruitment/data collection.

Contacts and Locations

Study Contact

Lara Blumstein
CONTACT
312-355-2328
lbb@uic.edu

Principal Investigator

Lisa Tussing-Humphreys, PhD, RD
PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago
Marian Fitzgibbon, PhD
PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago

Study Locations (Sites)

University of Illinois at Chicago
Chicago, Illinois, 60612
United States

Collaborators and Investigators

Sponsor: University of Illinois at Chicago

  • Lisa Tussing-Humphreys, PhD, RD, PRINCIPAL_INVESTIGATOR, University of Illinois at Chicago
  • Marian Fitzgibbon, PhD, PRINCIPAL_INVESTIGATOR, University of Illinois at Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-01
Study Completion Date2025-03-31

Study Record Updates

Study Start Date2022-02-01
Study Completion Date2025-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Colorectal Cancer
  • Diet Habit