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Trial record 6 of 115 for:    cancer | butyrate

Microbiome, Exercise Tracking Study (METS)

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ClinicalTrials.gov Identifier: NCT02780284
Recruitment Status : Unknown
Verified May 2016 by Heather Greenlee, Columbia University.
Recruitment status was:  Recruiting
First Posted : May 23, 2016
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
Heather Greenlee, Columbia University

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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Physical activity intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Physical Activity and the Microbiome Among Individuals at High Risk of Colorectal Cancer
Study Start Date : March 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physical activity intervention
Observation phase of usual activity and an intervention phase of regular physical activity
Behavioral: Physical activity intervention
150 minutes per week of moderate intensity cardiovascular exercise




Primary Outcome Measures :
  1. Percentage of participants retained at the end of study [ Time Frame: 8 weeks ]
    To demonstrate the feasibility of recruiting and retaining adults at high risk of colorectal cancer to a physical activity intervention trial


Secondary Outcome Measures :
  1. Percentage of participants with collected, processed, and analyzed stool samples [ Time Frame: 8 weeks ]
    To demonstrate the feasibility of collecting, processing, storing stool samples and analyzing gut microbiome data



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780284


Contacts
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Contact: Heather Greenlee, ND, PhD 212-342-4130 hg2120@columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Heather Greenlee, ND, PhD    212-342-4130    hg2120@columbia.edu   
Principal Investigator: Heather Greenlee, ND, PhD         
Principal Investigator: Brent Williams, PhD         
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Heather Greenlee, ND, PhD Columbia University

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Responsible Party: Heather Greenlee, Assistant Professor of Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT02780284     History of Changes
Other Study ID Numbers: AAAP1611
First Posted: May 23, 2016    Key Record Dates
Last Update Posted: May 23, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Heather Greenlee, Columbia University:
Gut Microbiota
Butyrate
Physical activity
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases