My Best GI Eating Study

NCT05396846 | Active Not Recruiting DMC

• 2 other identifiers: HUM00197337R01CA255743
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The MyBestGI study evaluates three different approaches that could help people eat in healthier ways. The study seeks to enroll 240 overweight and obese persons who have risk factors for colorectal cancers such as a family or personal history of colorectal cancers or adenomatous polyps. The study website is www.MyBestGI.org . Participants in the study will be asked to follow one of three eating plans, as best they can, for 12 months. Study participants can choose the foods they prefer within healthy food groups. Two of the eating plans involve ten brief telephone support calls and use of a web-based app (MyBestGI App). The study primarily evaluates improvements in eating and any weight change that may result. Secondary goals for the research are to evaluate how changes in eating affect metabolic pathways. All study participants will receive written materials that encourage making room for preventive foods in your daily eating. All participants also receive the results of their own diet analyses, and results of their own measures at study visits. The measures are the Veggie Meter skin reflectance test, Ketoscan breath test, and body composition measures. Study visits also involve providing a small blood sample from the arm. Study visits are in Ann Arbor at the start of the study, and at 6 and 12 months. The long-term goal of this research is to provide better options for supporting individuals who seek to achieve and maintain a preventive style of eating.

Conditions

Colorectal Neoplasms

Keywords

Prevention; Diet

Outcome Measures

Primary Outcomes (2)

• Preventive Food Score

  a score of 10 dietary components (0-10, with 10 being the most optimal score)

  Change over 12 months

• Weight Loss

  change in weight from baseline (in pounds)

  Change over 12 months

Other Outcomes (2)

• Breath Ketone Concentration

  Change over 12 months

• Skin Carotenoids

  Change over 12 months

Study Arms (3)

Eating Plan 1

ACTIVE COMPARATOR

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.

Behavioral: Eating Plan 1

Eating Plan 2

EXPERIMENTAL

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.

Behavioral: Eating Plan 2

Eating Plan 3

EXPERIMENTAL

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.

Behavioral: Eating Plan 3

Interventions

Eating Plan 1 BEHAVIORAL

The goal is to follow a preventive style of eating that is thought to lower the risk of colorectal cancers.

Eating Plan 1

Eating Plan 2 BEHAVIORAL

The goal is to follow a preventive style of eating that is thought to lower the risk of colorectal cancers.

Eating Plan 2

Eating Plan 3 BEHAVIORAL

The goal is to follow a preventive style of eating that is thought to lower the risk of colorectal cancers.

Eating Plan 3

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons ages 19 and older
• The subject has been properly informed of the study, they agree to participate, and sign the Informed Consent document(s)
• Measured body mass index of 25-45 kg/m2 at the study eligibility visit months OR waist circumference \> 88 cm for women or \> 102 cm for men.
• Reasonably stable weight in the last two months
• Increased risk of colorectal cancer as defined by: Prior adenomatous polyp or serrated polyp OR prior resected early stage CRC (Stage I-IIIA or T1-3, N0-1, M0) OR a history of CRC in at least one primary relative or in at least two secondary relatives OR a polyp was found with a recommended follow-up colonoscopy in less than 8 years OR A known genetic condition that increases risk of CRC
• Good general health
• Have reasonable control over their own dietary intakes
• Not expecting major lifestyle changes in the next 12 months.
• Not expecting a change in hormonal therapies over the next 12 months
• Have and use a smartphone with web access
• Can be contacted by telephone for support calls
• Read and speak English
• Are able to follow a diet high in fiber-containing foods
• Agree to be randomized to a control condition of usual care versus a dietary intervention involving app use and telephone contacts
• Successfully complete three 24-hour dietary recalls online prior to baseline with plausible dietary intakes

You may not qualify if:

• Persons with BMI \>45 kg/m2 since very high BMI values could indicate more prevalent health problems.
• On medically prescribed diets or other medical contraindications to dietary modification
• Are within 12 months of bariatric surgery
• Pregnant or lactating women or women contemplating pregnancy for the duration of the protocol
• Taking anti-coagulants that interfere with ability to obtain a blood sample
• Has a history of cytotoxic treatment (radiation, chemotherapy) for any type cancer within the last 12 months, except for basal cell or squamous cell tumors of the skin that have been surgically excised and required no further treatment
• Have cancer at the present time
• Dietary intakes with substantial nutrient deficiencies that would require extensive counseling to correct, such as obtaining a large portion of calories from alcohol
• Unable to make their own daily food choices
• Showing evidence of lack of reliability or non-adherence to study procedures (for example, missing an eligibility screening or baseline enrollment appointment more than twice; unable to recall the previous day's diet)
• Reported dietary intakes reported that are not plausible or highly unusual as reported on the ASA24 (for example: \<500 or \>3500 kcal/day for women and \<800 or \>4200 kcal/day for men; or reporting too few foods eaten)
• Has an infectious disease at the present time (such as HIV or hepatitis C).
• Unable to read, write, or speak English
• Unable to give informed consent

Sponsors & Collaborators

• University of Michigan: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Zora Djuric, PhD

  University of Michigan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All data and samples will be identified by a participant ID number and visit number. Results will be unblinded with regard to study arm assignment during statistical analysis only.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Model Details: Participants will be stratified by self-reported gender (male/female) and randomized across three study arms in a mixed block size, after baseline assessments are completed. Indeterminate gender will be classified as male for the purpose of randomization. The lists will be generated by the study statistician and opaque envelopes will contain the diet arm assignment for sequential participant IDs in the two strata.

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 31, 2022
• Study Start: June 13, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The primary endpoint data is anticipated to be available by the end of 2026.
• Access Criteria: The proposed research use must fall within what is allowed by the consent form.

Locations

US (1)