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Environmental Health Effects on Your Physiology (HYPHY)

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ClinicalTrials.gov Identifier: NCT03986814
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Tanya Alderete, University of Colorado, Boulder

Brief Summary:
This study evaluates the associations between exposure to air pollutants, green space, and the gut microbiome and metabolome.

Condition or disease
Obesity

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 Hispanic 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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Exposure to Air Pollutants and Green Space: Implications for the Gut Microbiome and Metabolome in Hispanic Young Adults Living in Denver, Colorado
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Gut Microbiome [ Time Frame: Measured once at baseline visit date ]
    16S rRNA and Shotgun Sequencing

  2. Fecal Metabolome [ Time Frame: Measured once at baseline visit date ]
    Targeted and/or Un-targeted Metabolomics

  3. 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

  4. Body Composition (kg) [ Time Frame: Measured once at baseline visit date ]
    DEXA scans to measure body composition, including body fat percent (%), body fat mass (kg), and body lean mass (kg)


Secondary Outcome Measures :
  1. Air Pollution [ Time Frame: One year before baseline visit date ]
    Modeled residential exposure to air pollution

  2. Green Space [ Time Frame: One year before baseline visit date ]
    Modeled residential exposure to green space

  3. Serum Metabolome [ Time Frame: Measured once at baseline visit date ]
    Targeted and/or Un-targeted Metabolomics

  4. Diet [ Time Frame: Measured once at baseline ]
    Automated Self-Administered 24-Hour (ASA24)

  5. Physical Activity [ Time Frame: Measured once at baseline ]
    International Physical Activity Questionnaire

  6. Fasting Glucose [ Time Frame: Measured once at baseline ]
    Fasting Glucose (mg/dl)

  7. Fasting Insulin [ Time Frame: Measured once at baseline ]
    Fasting insulin (uU/mL)


Biospecimen Retention:   Samples With DNA
Blood and fecal samples.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Hispanic young adults from Denver, Colorado.
Criteria

Inclusion Criteria:

  • The participant population includes overweight and obese Hispanic young adults (18-25 years of age) who live in Denver, Colorado.
  • Overweight and obese will be determined using body mass index (BMI) cut-offs set by the Center for Disease Control ("Overweight": BMI ≥25 and <30kg/m2 and "Obesity": ≥30 and <40kg/m2).

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).

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): NCT03986814


Contacts
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Contact: Tanya L Alderete, PhD 3037356249 tanya.alderete@colorado.edu

Sponsors and Collaborators
University of Colorado, Boulder

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Responsible Party: Tanya Alderete, Assistant Professor, University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT03986814     History of Changes
Other Study ID Numbers: 19-0201
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No