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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

Must not have

History of bariatric surgery

Cancer treatment within the past 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 month

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is between 30 and 50.

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I am between 45 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had weight loss surgery in the past.

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I have not had cancer treatment in the last year.

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I am currently on a weight loss diet or in a weight loss program.

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I have a condition that affects how my body absorbs nutrients.

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I have a genetic condition that increases my risk for colon cancer.

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I have a severe lung condition.

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I have a weakened immune system.

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I regularly use products like probiotics or fiber supplements more than 3 times a week.

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I have a history of colorectal cancer.

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I have difficulty walking.

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I have serious stomach or liver diseases.

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I have severe heart disease related to poor blood flow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 month

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bile Acids

Exfoliated intestinal epithelial cell transcriptomics

Gene expression

+1 more

Secondary study objectives

Body mass index

Body weight

Circulating cytokines

+6 more

Other study objectives

Adverse events

Bowel habits

Medication use

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 14Eligibility criteria met