Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04753359 · ClinicalTrials.gov registry record · NA
Mediterranean Diet and Weight Loss: Targeting the Bile Acid/Gut Microbiome Axis to Reduce Colorectal Cancer
A NA study of Colorectal Cancer and Diet Habit, sponsored by University of Illinois at Chicago.
- Recruiting
- Registry status
- NA
- Development phase
- 232
- Enrollment target
- 1
- Study location
NCT04753359: Recruiting NA study of Colorectal Cancer and Diet Habit, sponsored by University of Illinois at Chicago.
NCT04753359 is a NA study of Colorectal Cancer and Diet Habit that is actively recruiting participants, run by University of Illinois at Chicago. The registered enrollment target is 232 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04753359, a NA study of Colorectal Cancer and Diet Habit, is actively recruiting participants, sponsored by University of Illinois at Chicago.
- RECRUITING
- Registry status
- NA
- Development phase
- 232 participants
- Enrollment target
- 1
- Study location
Study 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 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.
Primary Outcome
Absolute measurement of BAs in stool and serum obtained at baseline will be performed under the direction of Co-I Ridlon. Samples will be extracted, and supernatants will be dried and resuspended for LC/MS analysis following validated and published methods. We will quantify all major primary and secondary BAs (e.g., DCA) and glycine and taurine conjugates and their ratios, as well as total BAs and total unconjugated BAs. Authentic reference BAs will be purchased from Sigma-Aldrich and Steraloids
Conditions Studied
Interventions
- OTHER Med
- OTHER WL
Study Locations (1)
Illinois
- University of Illinois at Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2022-02-01 |
| Est. Completion | 2025-03-31 |
| Phase | NA |
What NCT04753359 shows while recruiting
NCT04753359 is an interventional study that assigns participants to a tested intervention. The registered 232 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (85% lower).
The record links to 2 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions - of which Med is the first listed.
NCT04753359 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT04753359 about?
NCT04753359 is a clinical study titled "Mediterranean Diet and Weight Loss: Targeting the Bile Acid/Gut Microbiome Axis to Reduce Colorectal Cancer". 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 adheren...
What is the current status of trial NCT04753359?
This trial is currently recruiting. It is a NA study. The enrollment target is 232 participants. The study started on 2022-02-01. Estimated completion is 2025-03-31.
What conditions does trial NCT04753359 study?
This clinical trial studies the following conditions: Colorectal Cancer, Diet Habit.
What interventions are being tested in trial NCT04753359?
The interventions under investigation include: Med (OTHER), WL (OTHER).
Who is sponsoring clinical trial NCT04753359?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04753359 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04753359's enrollment target sits among peer trials
232 136th of 381 higher than 246 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Cross-sectional Partnership to Improve Prevention and Health Equity Among African Americans
RECRUITING · NA
-
Precise Oncology Interventions in Nutrition and Training (OnPoint)
RECRUITING · NA
-
Resistance Exercise and Creatine in Colorectal Cancer
RECRUITING · NA
-
Optimal Perioperative Pain Control in Minimally Invasive Abdominal Cancer Surgery
RECRUITING · NA
-
Ultrasound and Photoacoustic Imaging for Enhanced Differential Diagnosis of Rectal Cancer
RECRUITING · NA
-
PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01356290 · 232 participants · Phase 2
Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors
- NCT04770870 · 232 participants · NA
Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System
- NCT05948943 · 232 participants · Phase 2
Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.
- NCT06213649 · 232 participants · Phase 3
Parasitic Ulcer Treatment Trial
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI