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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02780284

Acronym

METS

Enrollment

Registered

2016-05-23

Start date

2015-03-31

Completion date

2020-09-15

Last updated

2022-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Gut Microbiota, Butyrate, Physical activity

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.

Interventions

BEHAVIORALPhysical activity intervention

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 69 Years

Healthy volunteers

Inclusion criteria

1. Fluent in English or Spanish; 2. At high risk of developing colorectal cancer; 3. No history of colorectal cancer, including germ-line heritable colorectal cancers such as Familial Adenomatous Polyposis (FAP) and Hereditary Nonpolyposis Colorectal Cancer (HNPCC); 4. No use of antibiotics in the previous 3 months; or current regular use of antibiotics 5. Access to either smart phone or computer; and 6. Currently physically inactive.

Exclusion criteria

Any criterion not met under inclusion.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of participants retained at the end of study	8 weeks	To demonstrate the feasibility of recruiting and retaining adults at high risk of colorectal cancer to a physical activity intervention trial

Secondary

Measure	Time frame	Description
Percentage of participants with collected, processed, and analyzed stool samples	8 weeks	To demonstrate the feasibility of collecting, processing, storing stool samples and analyzing gut microbiome data

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026