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Diet Intervention for Colorectal Cancer Prevention

N/A

Recruiting

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of CRC in at least one primary relative or in at least two secondary relatives

Prior resected early-stage CRC (Stage I-IIIA or T1-3, N0-1, M0)

Must not have

Has an infectious disease at the present time.

Has a history of cytotoxic treatment (radiation, chemotherapy) for any type cancer within the last year, except for basal cell or squamous cell tumors of the skin that have been surgically excised and required no further treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change over 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing different diets to see which is the most effective in preventing colorectal cancer in people who are overweight or obese.

Who is the study for?

This study is for overweight or obese adults with a history of early-stage colorectal cancer or polyps, or who have a family history of these conditions. Participants should be able to control their diet and not expect major lifestyle changes in the next year. They must also be willing to use an app and receive support calls.

What is being tested?

The MyBestGI study tests three different healthy eating plans over 12 months to see which helps improve diet quality and potentially reduce weight. It includes telephone support, a web-based app, and regular check-ups with body composition measures and blood samples in Ann Arbor.

What are the potential side effects?

There are no direct side effects from participating as this trial involves dietary interventions rather than medication. However, changes in diet can affect individuals differently; some may experience digestive adjustments or need medication dosage changes if they manage other conditions.

Eligibility Criteria

Inclusion Criteria

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

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One of my close family members or at least two distant relatives had colorectal cancer.

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I had surgery for early-stage colorectal cancer.

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I have a genetic condition that raises my risk for colorectal cancer.

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I agree to possibly follow a special diet plan or continue my usual care.

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I have had a type of polyp called adenomatous before.

Exclusion Criteria

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

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I currently have an infectious disease.

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I haven't had cancer treatment in the last year, except for minor skin cancer surgery.

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I cannot make my own daily food choices.

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I am on blood thinners that may affect blood sampling.

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I am unable to understand and agree to the study's procedures and risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change over 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change over 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change over 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Preventive Food Score

Weight Loss

Other study objectives

Breath Ketone Concentration

Skin Carotenoids

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Eating Plan 3Experimental Treatment1 Intervention

This group will receive a version of the MyBestGI App and User Manual that encourages meeting 11 food group goals: four food groups to limit and seven food groups to encourage. The 7 groups to encourage are: 3-4 cups/day fruits and vegetables, at least one dark orange or dark green vegetable daily, daily allium and culinary herbs, 3-6 oz./day whole grains, 6-8 oz./week foods high in omega-3 fatty acids, 8-10 tsp./day olive oil or the equivalent from other foods high in monounsaturated fats and at least ½ cup/day of legumes or 1 TB/day nut butter. Some of the goals are personalized based on calculated energy needs. They will also receive the results of their own breath test, Veggie Meter score and anthropometric measures.

Group II: Eating Plan 2Experimental Treatment1 Intervention

This group will receive the MyBestGI App and User Manual that encourages limiting four food groups: three or less foods each day made with refined flour, no more than 8% of calories from added sugars, no processed meats and less than 18 oz./week red meat. They will also receive the results of their own breath test, Veggie Meter score and anthropometric measures.

Group III: Eating Plan 1Active Control1 Intervention

This group will receive a pamphlet from the American Institute for Cancer Research (AICR) on dietary prevention and the results of their own breath test, Veggie Meter score and anthropometric measures.

0 / 11Eligibility criteria met