Simple Eating Plan for Colorectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Michigan, Ann Arbor, MI
Colorectal Cancer
Simple Eating Plan - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This proposal seeks to develop methods that could be used in medical settings to assist high risk individuals in attaining both the weight management and diet quality goals for prevention of colorectal (CRC) cancer. This study tests two different dietary interventions versus a control group in overweight and obese persons who are at increased risk of CRC. The study will recruit 240 study participants. Participants will be randomized to receive to 12 months of a: 1) Self-Guided Eating Plan, a control group that receives written information on cancer preventive diets from the American Institute for Cancer Research (The New American Plate brochure), 2) a Simple Eating Plan that simply encourages a limit on four Western food groups associated with increased risk of CRC to make room for better choices, or 3) a Full Eating Plan that combines goals for both limiting Western foods and consuming preventive foods to achieve a modified Mediterranean type of diet. The dietary changes are expected to improve diet quality and achieve a sustainable, slow rate of weight loss over time that is likely more favorable for cancer prevention than conventional obesity treatment.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Change over 12 months

Change over 12 months
Breath Ketone Concentration
Preventive Food Score
Skin Carotenoids
Weight Loss

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Self-Guided Eating Plan
1 of 3
Full Eating Plan
1 of 3
Simple Eating Plan
1 of 3
Active Control
Experimental Treatment

240 Total Participants · 3 Treatment Groups

Primary Treatment: Simple Eating Plan · No Placebo Group · N/A

Full Eating Plan
Behavioral
Experimental Group · 1 Intervention: Full Eating Plan · Intervention Types: Behavioral
Simple Eating Plan
Behavioral
Experimental Group · 1 Intervention: Simple Eating Plan · Intervention Types: Behavioral
Self-Guided Eating Plan
Behavioral
ActiveComparator Group · 1 Intervention: Self-Guided Eating Plan · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change over 12 months
Closest Location: University of Michigan · Ann Arbor, MI
Photo of university of michigan comprehensive cancer center 1Photo of university of michigan comprehensive cancer center 2Photo of university of michigan comprehensive cancer center 3
2022First Recorded Clinical Trial
0 TrialsResearching Colorectal Cancer
1005 CompletedClinical Trials

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,930 Previous Clinical Trials
41,294,220 Total Patients Enrolled
University of MichiganLead Sponsor
1,597 Previous Clinical Trials
6,328,817 Total Patients Enrolled
Zora Djuric, PhDStudy ChairUniversity of Michigan
5 Previous Clinical Trials
374 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are stable in weight within five pounds in the last two months as determined by self-report.
You have been properly informed of the study, you agree to participate, and you sign the Informed Consent document.
You have excess adiposity as measured at the study screening visit.
You have a body mass index of 25-45 kg/m2.
You have a history of colorectal cancer in at least one primary relative or in at least two secondary relatives.
You are in good general health.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.