Back to results

Microbiome, Exercise Tracking Study: Among Individuals at High Risk for Colorectal Cancer (METS)

Primary Purpose

Colorectal Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Physical activity intervention

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring Gut Microbiota, Butyrate, Physical activity

Eligibility Criteria

21 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Fluent in English or Spanish;
At high risk of developing colorectal cancer;
No history of colorectal cancer, including germ-line heritable colorectal cancers such as Familial Adenomatous Polyposis (FAP) and Hereditary Nonpolyposis Colorectal Cancer (HNPCC);
No use of antibiotics in the previous 3 months; or current regular use of antibiotics
Access to either smart phone or computer; and
Currently physically inactive.

Exclusion Criteria:

Any criterion not met under inclusion.

Sites / Locations

Columbia University Irving Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical activity intervention

Arm Description

Subjects at higher risk of developing colorectal cancer will maintain the current level of activity during the first 4 weeks and exercise 150 minutes per week during the last 4 weeks. During the entire study, subjects will wear a Fitbit device on their wrist.

Outcomes

Primary Outcome Measures

Percentage of participants retained at the end of study

To demonstrate the feasibility of recruiting and retaining adults at high risk of colorectal cancer to a physical activity intervention trial

Secondary Outcome Measures

Percentage of participants with collected, processed, and analyzed stool samples

To demonstrate the feasibility of collecting, processing, storing stool samples and analyzing gut microbiome data

Full Information

NCT ID

NCT02780284

First Posted

May 19, 2016

Last Updated

October 11, 2022

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT02780284

Brief Title

Microbiome, Exercise Tracking Study: Among Individuals at High Risk for Colorectal Cancer

Acronym

METS

Official Title

Gut Microbiota, Butyrate, Inflammation and Physical Activity: A Pilot Study Among Individuals at High Risk for Colorectal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

March 2015 (Actual)

Primary Completion Date

September 15, 2020 (Actual)

Study Completion Date

September 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Columbia University

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 purpose of this study has 2 aims: Aim 1: To demonstrate the feasibility of recruiting and retaining adults at high risk of colorectal cancer to a physical activity intervention trial. Investigators hypothesize that it will be possible to recruit and retain this patient population to a physical activity intervention trial. Aim 2: To demonstrate the feasibility of collecting, processing, storing stool samples and analyzing the gut microbiome data. Investigators hypothesize that all of these steps are feasible.

Detailed Description

Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the U.S. and is the third most common cancer in men and women. CRC risk factors include genetic predisposition, host factors and modifiable lifestyle behaviors (e.g., diet, physical activity, obesity). There are very limited data on the differences in the gut microbiota among populations at different levels of CRC risk, as well as the effects of behavioral interventions to alter the gut microbiome.

6. Conditions and Keywords

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

Colorectal Cancer

Keywords

Gut Microbiota, Butyrate, Physical activity

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Physical activity intervention

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Physical activity intervention

Intervention Description

150 minutes per week of moderate intensity cardiovascular exercise. The exercise sessions will include a minimum of 30 minutes of exercise each day, 3 to 5 times per week for a total of 150 minutes of exercise per week.

Primary Outcome Measure Information:

Title

Percentage of participants retained at the end of study

Description

To demonstrate the feasibility of recruiting and retaining adults at high risk of colorectal cancer to a physical activity intervention trial

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Percentage of participants with collected, processed, and analyzed stool samples

Description

To demonstrate the feasibility of collecting, processing, storing stool samples and analyzing gut microbiome data

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Fluent in English or Spanish; At high risk of developing colorectal cancer; No history of colorectal cancer, including germ-line heritable colorectal cancers such as Familial Adenomatous Polyposis (FAP) and Hereditary Nonpolyposis Colorectal Cancer (HNPCC); No use of antibiotics in the previous 3 months; or current regular use of antibiotics Access to either smart phone or computer; and Currently physically inactive. Exclusion Criteria: Any criterion not met under inclusion.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heather Greenlee, ND, PhD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Irving Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Microbiome, Exercise Tracking Study: Among Individuals at High Risk for Colorectal Cancer

We'll reach out to this number within 24 hrs