NCT04753359: Bridge CRC

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

Recruiting now NA Last updated 21 August 2024

What this trial tests

NA trial testing Med in Colorectal Cancer in 232 participants. Currently enrolling.

Timeline

1 February 2022

Primary endpoint
31 March 2025

31 March 2025

Quick facts

Lead sponsor	University of Illinois at Chicago
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	232
Start date	1 February 2022
Primary completion	31 March 2025
Estimated completion	31 March 2025
Sites	1 location across United States

Drugs / interventions tested

• Med
• WL

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →
• Diet Habit — all drugs for Diet Habit →

Sponsor

University of Illinois at Chicago

Who can join

Adults 45 to 75, any sex, with Colorectal Cancer or Diet Habit. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advances in Diet and Physical Activity in Breast Cancer Prevention and Treatment.
   Khalifa A, Guijarro A, Nencioni A. · · 2024 · cited 17× · PMID 39064705 · DOI 10.3390/nu16142262
2. Design of the Building Research in CRC prevention (BRIDGE-CRC) trial: a 6-month, parallel group Mediterranean diet and weight loss randomized controlled lifestyle intervention targeting the bile acid-gut microbiome axis to reduce colorectal cancer risk among African American/Blac
   McLeod A, Wolf P, Chapkin RS, Davidson LA, et al · · 2023 · cited 14× · PMID 36793105 · DOI 10.1186/s13063-023-07115-4
3. Diet-driven microbiome changes and physical activity in cancer patients.
   Ciernikova S, Sevcikova A, Stevurkova V, Mego M. · · 2023 · cited 11× · PMID 38075222 · DOI 10.3389/fnut.2023.1285516
4. Shaping the Future of Immunotherapy Targets and Biomarkers in Melanoma and Non-Melanoma Cutaneous Cancers.
   Spiliopoulou P, Vornicova O, Genta S, Spreafico A. · · 2023 · cited 10× · PMID 36674809 · DOI 10.3390/ijms24021294
5. Crosstalk between metabolic reprogramming and microbiota: implications for cancer progression and novel therapeutic opportunities.
   Li X, Jia Y, Li Y, Hei H, et al · · 2025 · cited 2× · PMID 40463381 · DOI 10.3389/fimmu.2025.1582166