Back to results

My Best GI Eating Study

Primary Purpose

Colorectal Neoplasms

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Eating Plan 1

Eating Plan 2

Eating Plan 3

About this trial

This is an interventional health services research trial for Colorectal Neoplasms focused on measuring Prevention, Diet

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

Men and women ages 19 and older
The subject has been properly informed of the study, they agree to participate, and sign the Informed Consent document
Excess adiposity as measured at the study screening visit
o Body mass index of 25-45 kg/m2
Stable weight, within five pounds, in the last two months as determined by self-report
Increased risk of colorectal cancer as defined by one or more of the following:
- Prior adenomatous polyp
- Prior resected early-stage CRC (Stage I-IIIA or T1-3, N0-1, M0)
- History of CRC in at least one primary relative or in at least two secondary relatives
- 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.
Have and use a compatible smartphone with a cellular data.
Can be contacted by telephone for study support calls
Read, write, 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 and a food frequency questionnaire by visit 2 with plausible dietary intakes
If taking medications for conditions that are affected by diet (diabetes, high blood pressure) must be willing to continue to follow-up with their personal medical provider as needed to manage those conditions and the medication dosing, which may need to be adjusted due to diet changes.

Exclusion Criteria:

Persons with BMI >45.5 kg/m2 since very high BMI values could indicate more prevalent health problems.
On medically prescribed diets or other medical contraindications to the study diets
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
Pregnant or lactating women or women contemplating pregnancy for the duration of the protocol
Uncontrolled high blood pressure
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 2 years, except for basal cell or squamous cell tumors of the skin that have been surgically excised and required no further treatment
Unable to read, write, or speak English
Unable to give informed consent
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 DHQ3 (for example: <500 or >3500 kcal/day for women and <800 or >4200 kcal/day for men; or reporting too few foods eaten over the past year)
Has an infectious disease at the present time.

Sites / Locations

University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Eating Plan 1

Eating Plan 2

Eating Plan 3

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Preventive Food Score

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

Weight Loss

change in weight from baseline (in pounds)

Secondary Outcome Measures

Full Information

NCT ID

NCT05396846

First Posted

May 19, 2022

Last Updated

April 29, 2023

Sponsor

University of Michigan

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT05396846

Brief Title

My Best GI Eating Study

Official Title

MyGI Diet for Colorectal Cancer Prevention

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 29, 2023 (Actual)

Primary Completion Date

July 1, 2027 (Anticipated)

Study Completion Date

February 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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. 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.

Detailed Description

Despite the large body of research that has identified the impact of diet on cancer risk, little has been done to improve how care is provided to persons who have risk factors for cancer. The MyBestGI study addresses prevention of colorectal cancer, the third most prevalent cancer in the U.S. Colorectal cancer is among the cancers that are most strongly affected by diet and excess adiposity, and incidence is increasing in young people below the age of 40. More efforts need to be directed at providing individuals with the tools needed for achieving and maintaining a preventive style of eating. Recommendations for cancer prevention from the American Cancer Society and American Institute for Cancer Research include advice to maintain a healthy weight, to consume more plant-based foods, and to limit red meats, processed meats, and foods with added sugar. This study addresses the development of methods that in the future could feasibly be implemented in medical and community settings to assist individuals with risk factors in attaining both the weight management and diet quality goals for prevention of colorectal cancer. The MyBestGI study seeks to test three dietary interventions in overweight and obese persons who have risk factors for colorectal cancer. Study participants in all groups receive the results of the Veggie Meter, breath ketones using Ketoscan and body composition testing (InBody270) at study visits. A small blood sample from the arm is taken at each visit for research on how eating affects metabolism. The MyBestGI study will recruit 240 participants who will be randomized to receive to 12 months of: 1) Eating Plan 1, a group that receives written information on cancer preventive diets; 2) Eating Plan 2 that encourages limiting and logging four food groups associated with increased risks, namely foods containing refined flour, added sugars, processed meats, and red meats; or 3) Eating Plan 3 that combines logging of both food groups to limit and preventive food groups to encourage. Eating Plans 2 and 3 will be supported by written educational materials, brief telephone support calls, and the MyBestGI app. The main outcome is to evaluate to what extent these methods improve eating and possibly achieve weight loss over the year of study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Neoplasms

Keywords

Prevention, Diet

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

Outcomes Assessor

Masking Description

All data and sample will be identified by a participant ID number and visit number. Results will be unblinded with regard to study arm during statistical analysis only.

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Eating Plan 1

Arm Type

Active Comparator

Arm Description

Arm Title

Eating Plan 2

Arm Type

Experimental

Arm Description

Arm Title

Eating Plan 3

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Eating Plan 1

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Eating Plan 2

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Eating Plan 3

Intervention Description

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

Primary Outcome Measure Information:

Title

Preventive Food Score

Description

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

Time Frame

Change over 12 months

Title

Weight Loss

Description

change in weight from baseline (in pounds)

Time Frame

Change over 12 months

Other Pre-specified Outcome Measures:

Title

Breath Ketone Concentration

Description

Ketoscan measure

Time Frame

Change over 12 months

Title

Skin Carotenoids

Description

Veggie Meter reading

Time Frame

Change over 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria In order to be eligible to participate in this study, an individual must meet all of the following criteria: Men and women ages 19 and older The participant has been properly informed of the study, they agree to participate, and sign the Informed Consent document Body mass index of 25-45 kg/m2 or waist circumference > 88 cm for women or > 102 cm for men Stable weight, within five pounds, in the last two months as determined by self-report Increased risk of colorectal cancer as defined by one or more of the following: Prior adenomatous polyp Prior resected early-stage CRC (Stage I-IIIA or T1-3, N0-1, M0) History of CRC in at least one primary relative or in at least two secondary relatives 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. Have and willing to use a compatible smartphone with a cellular data for the study. Can be contacted by telephone for study support calls Read, write, 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 before visit 2 with plausible dietary intakes If taking medications for conditions that are affected by diet (diabetes, high blood pressure), must be willing to continue to follow-up with their personal medical provider as needed to manage those conditions and the medication dosing, which may need to be adjusted due to diet changes. Exclusion Criteria: Persons with BMI >45.5 kg/m2 since very high BMI values could indicate more prevalent health problems. On medically prescribed diets or other medical contraindications to the study diets 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 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 year, except for basal cell or squamous cell tumors of the skin that have been surgically excised and required no further treatment Unable to read, write, or speak English Unable to give informed consent 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 Has an infectious disease at the present time.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rob Adwere-Boamah, MA

Phone

734-232-4971

MyBestGIstudy@umich.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zora Djuric, PhD

Organizational Affiliation

University of Michigan

Official's Role

Study Chair

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rob Adwere-Boamah, M.A.

Phone

734-232-4971

MyBestGIstudy@umich.edu

First Name & Middle Initial & Last Name & Degree

Study Chair

Phone

734-936-4494

First Name & Middle Initial & Last Name & Degree

Zora Djuric, PhD

First Name & Middle Initial & Last Name & Degree

Lorraine Buis, PhD

First Name & Middle Initial & Last Name & Degree

Ananda Sen, PhD

First Name & Middle Initial & Last Name & Degree

Michelle Segar, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

This clinical trial will collect data and blood samples from people enrolled in the trial. The study team is open to sharing de-identified data for collaborative work if the scope of the project falls within what was stated in the consent document used for the study. De-identified, aggregate data will also be available upon request for preparation of review articles and meta-analyses. If biosamples are available for sharing after completion of study measures, all sharing and transfer of human data and biospecimens will occur in accordance with sound scientific and ethical principles and shall comply with all applicable laws, regulations, and the policies of the National Institutes of Health and the University of the Michigan.

IPD Sharing Time Frame

Data is anticipated to be available in mid-2027.

IPD Sharing Access Criteria

The proposed research use must fall within what is allowed by the consent form.

Learn more about this trial

My Best GI Eating Study

We'll reach out to this number within 24 hrs