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Mediterranean Diet + Lifestyle Changes for Colorectal Cancer Prevention (Bridge CRC Trial)

N/A
Recruiting
Led By Lisa Tussing-Humphreys, PhD, RD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
BMI 30-50 kg/m2
Men and women 45-75 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month
Awards & highlights

Bridge CRC Trial Summary

This trial will test the effects of a Mediterranean Diet, weight loss through lifestyle changes, and a calorie-restricted Mediterranean Diet on the gut microbiome and its relevance to colorectal cancer prevention among African Americans.

Who is the study for?
This trial is for African American men and women aged 45-75 with a BMI of 30-50, willing to follow diet interventions or maintain current habits as assigned. Exclusions include autoimmune, severe heart or lung diseases, recent cancer treatment, certain genetic risks for colorectal cancer (CRC), substance abuse, uncontrolled diabetes, and other specific health conditions.Check my eligibility
What is being tested?
The study tests the effects of a Mediterranean Diet alone (Med-A), weight loss through lifestyle changes without diet pattern change (WL-A), calorie-restricted MedDiet for weight loss (WL-Med) versus control on bile acids and gut microbiome related to CRC prevention in obese individuals over six months.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include digestive changes due to new diets such as bloating or discomfort. Adherence to a new diet can also affect energy levels and mood temporarily.

Bridge CRC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is between 30 and 50.
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I am between 45 and 75 years old.

Bridge CRC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bile Acids
Exfoliated intestinal epithelial cell transcriptomics
Gene expression
+1 more
Secondary outcome measures
Body mass index
Body weight
Circulating cytokines
+6 more
Other outcome measures
Adverse events
Bowel habits
Medication use
+1 more

Bridge CRC Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: WL-MedExperimental Treatment2 Interventions
WL-Med will attend a one-hour, in-person session with a registered dietitian (RD) prior to the intervention. The RD will instruct on an eating pattern consistent with a MedDiet using an individualized exchange list. Exchanges are based on individual caloric needs to lose weight (WL-Med, calorie restriction to achieve a 1-2 lb. per week WL and 5% WL from baseline at 6 months). We will not ask subjects to abstain from alcohol despite its known effects on BA metabolism, but we will recommend that only 5% of calories come from alcohol taken with meals. Following the initial session, subjects will meet remotely or in-person for 24 individual sessions (1-hour, held approximately weekly). Additional asynchronous learning materials will be distributed weekly through a private Facebook group. The WL-Med group will be prescribed an activity program. Some asynchronous lessons will contain information about physical activity. Physical activity will be monitored via FitBit.
Group II: WL-AExperimental Treatment1 Intervention
WL-A will attend a one-hour, in-person individual session with a registered dietitian (RD) during the two weeks prior to the intervention. For WL-A, the focus will be on daily calorie restriction (-500-750 kcal/day) to achieve a 1-2 lb. per week WL and 5% WL from baseline at 6 months in the context of the subject's typical diet pattern. We will not ask subjects to abstain from alcohol during the trial despite its known effects on BA metabolism, but we will recommend that only 5% of calories come from alcohol taken with meals. Following the initial session, subjects will meet for 24 individual, virtual or in-person sessions (1-hour, held approximately weekly) over the remaining 6 months. Additional asynchronous learning materials will be distributed weekly through a private Facebook group. The WL-A group will be prescribed an activity program. Physical activity will be monitored via FitBit.
Group III: Med-AExperimental Treatment1 Intervention
Med-A will attend a one-hour, in-person individual session with a registered dietitian (RD) during the two weeks prior to the start of the intervention. For subjects randomized to Med-A the study RD will instruct on adoption of an eating pattern consistent with a MedDiet using an individualized MedDiet exchange list and companion guide. Recommended daily exchanges are based on individual caloric needs to maintain weight. We will not ask subjects to abstain from alcohol during the trial despite its known effects on BA metabolism, but we will recommend that only 5% of calories come from alcohol taken with meals. Following the initial session, subjects will meet for 24 individual sessions (1-hour, held approximately weekly) in-person or virtually over the remaining 6 months. Additional asynchronous learning materials will be distributed weekly through a private Facebook group. The Med-A group will be asked to maintain their usual physical activity.
Group IV: ControlActive Control1 Intervention
The study RD will meet individually with the Control group subjects in-person for 1-hour at the start of the 6-month intervention. Control participants will be instructed to maintain current eating and activity patterns and weight over the next 6 months. No dietary recommendations are provided, and they will receive weekly health newsletters that include non-diet related health topics (e.g., flu prevention). Contact will be made again at month-3 and post-intervention (month-6) research visits and during monthly phone calls to collect data pertaining to recent diet intake. At the month-3 assessment, weight will be checked and those with >2.5% WL from baseline will receive additional instruction from the RD to maintain lifestyle patterns. All WL-Med materials are offered to the group in a self-guided format following the 6-month intervention.

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
608 Previous Clinical Trials
1,559,017 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,661 Previous Clinical Trials
40,924,161 Total Patients Enrolled
Lisa Tussing-Humphreys, PhD, RDPrincipal InvestigatorUniversity of Illinois at Chicago

Media Library

Mediterranean Diet Clinical Trial Eligibility Overview. Trial Name: NCT04753359 — N/A
Colorectal Cancer Research Study Groups: WL-A, WL-Med, Control, Med-A
Colorectal Cancer Clinical Trial 2023: Mediterranean Diet Highlights & Side Effects. Trial Name: NCT04753359 — N/A
Mediterranean Diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT04753359 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have signed up to take part in this trial?

"Affirmative. Information available on clinicaltrials.gov corroborates that this experiment is actively recruiting patients and has been since it was posted in March 2022. It requires 232 participants to be recruited from a single medical facility for the study's completion."

Answered by AI

Are enrollees still being admitted to this research experiment?

"As clinicaltrials.gov confirms, this trial is currently in the process of finding participants. It was initially uploaded on March 23rd 2022 and last edited on October 26th 2022."

Answered by AI

Is this research endeavor accommodating senior citizens over the age of 85?

"To be considered for participation in this medical trial, individuals must possess the age range of 45 to 75. Conversely, there are 57 studies available for those below 18 and 1235 reports that cater to elderly citizens over 65 years old."

Answered by AI

Who is eligible to take part in this research initiative?

"This clinical trial is recruiting 232 individuals between 45 and 75 years of age who self-identify as African American, with a Body Mass Index between 30 to 50 kg/m2. Additional qualifications include the ability to understand English, having access to a phone, planning on staying in Chicago for 8-10 months, being willing to consent legally and participate fully in all procedures including maintaining weight or current physical activity if randomized into Med-A/Control."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
How old are they?
18 - 65
What site did they apply to?
University of Illinois at Chicago
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Mediterranean Diet and Weight Loss: Targeting the Bile Acid/Gut Microbiome Axis to Reduce Colorectal Cancer
Lisa Tussing-Humphreys 2022. "Mediterranean Diet and Weight Loss: Targeting the Bile Acid/Gut Microbiome Axis to Reduce Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04753359.
All > Colorectal Cancer Chicago > Microbiome
~73 spots leftby Apr 2025
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