- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03986814
Environmental Health Effects on Your Physiology (HYPHY)
May 8, 2023 updated by: Tanya Alderete, University of Colorado, Boulder
Exposure to Air Pollutants and Green Space: Implications for the Gut Microbiome and Metabolome in Young Adults Living in Denver, Colorado
This study evaluates the associations between exposure to air pollutants, green space, and the gut microbiome and metabolome.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
A rapidly evolving field of study suggests a link between the gut microbiome and fecal metabolome with obesity.
Recent studies show that environmental exposures, such as ambient air pollution (AAP) exposure can affect gut bacteria and modify risk for obesity.
Additionally, proximity to green space has been shown to reduce exposure to air pollutants and increase gut microbial diversity.
The investigator's preliminary work has shown that near-roadway air pollution exposure was positively correlated with gut microbial taxa that have been linked with obesity.
These findings suggest that air pollution exposure may increase susceptibility to obesity through alterations in the composition and function of the gut microbiome.
Despite this, no studies have systematically examined the impact of air pollutants and green space on the gut microbiome and metabolome among adolescents.
The overall goal of this research is to determine whether exposure to air pollutants and/or green space affect the gut microbiome and metabolome in young adults residing in Denver, Colorado.
This study will examine residential-based estimates of air pollution exposure and green space and also perform detailed gut microbial and metabolite profiling in 100 adolescent and young adults.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tanya L Alderete, PhD
- Phone Number: 3037356249
- Email: tanya.alderete@colorado.edu
Study Locations
-
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Colorado
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Boulder, Colorado, United States, 80309
- Clinical and Translational Research Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Young adults from Denver, Colorado.
Description
Inclusion Criteria:
- The participant population includes young adults (18-25 years of age) who live in Denver, Colorado.
Exclusion Criteria:
- Exclusion criteria include physical, mental, or cognitive disability that prevents participation
- Current incarceration
- Antibiotic usage in the previous month
- Pregnant or nursing
- Non-English speaking
- Any medical conditions known to affect body composition, insulin secretion, or the gut microbiota (i.e., type 1 or 2 diabetes, intestinal bowel disease, Crohn's Disease, kidney disease, heart disease, autoimmune disease).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gut Microbiome
Time Frame: Measured once at baseline visit date
|
16S rRNA and Shotgun Sequencing
|
Measured once at baseline visit date
|
Fecal Metabolome
Time Frame: Measured once at baseline visit date
|
Targeted and/or Un-targeted Metabolomics
|
Measured once at baseline visit date
|
Body mass index (BMI)
Time Frame: Measured once at baseline visit date
|
Weight and height will be combined to report BMI in kg/m^2
|
Measured once at baseline visit date
|
Body Composition
Time Frame: Measured once at baseline visit date
|
Waist and hip measurements will be taken
|
Measured once at baseline visit date
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Air Pollution
Time Frame: One year before baseline visit date
|
Modeled residential exposure to air pollution
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One year before baseline visit date
|
Green Space
Time Frame: One year before baseline visit date
|
Modeled residential exposure to green space
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One year before baseline visit date
|
Serum Metabolome
Time Frame: Measured once at baseline visit date
|
Targeted and/or Un-targeted Metabolomics
|
Measured once at baseline visit date
|
Diet
Time Frame: Measured once at baseline
|
Automated Self-Administered 24-Hour (ASA24)
|
Measured once at baseline
|
Physical Activity
Time Frame: Measured once at baseline
|
International Physical Activity Questionnaire
|
Measured once at baseline
|
Fasting Glucose
Time Frame: Measured once at baseline
|
Fasting Glucose (mg/dl)
|
Measured once at baseline
|
Fasting Insulin
Time Frame: Measured once at baseline
|
Fasting insulin (uU/mL)
|
Measured once at baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 18, 2019
Primary Completion (Anticipated)
December 30, 2023
Study Completion (Anticipated)
December 30, 2023
Study Registration Dates
First Submitted
June 10, 2019
First Submitted That Met QC Criteria
June 12, 2019
First Posted (Actual)
June 14, 2019
Study Record Updates
Last Update Posted (Actual)
May 9, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 19-0201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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