NCT03986814

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

July 18, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2022

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

2.6 years

First QC Date

June 10, 2019

Last Update Submit

December 4, 2024

Conditions

Obesity

Outcome Measures

Primary Outcomes (4)

  • Gut Microbiome

    16S rRNA and Shotgun Sequencing

    Measured once at baseline visit date

  • Fecal Metabolome

    Targeted and/or Un-targeted Metabolomics

    Measured once at baseline visit date

  • Body mass index (BMI)

    Weight and height will be combined to report BMI in kg/m\^2

    Measured once at baseline visit date

  • Body Composition

    Waist and hip measurements will be taken

    Measured once at baseline visit date

Secondary Outcomes (7)

  • Air Pollution

    One year before baseline visit date

  • Green Space

    One year before baseline visit date

  • Serum Metabolome

    Measured once at baseline visit date

  • Diet

    Measured once at baseline

  • Physical Activity

    Measured once at baseline

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young adults from Denver, Colorado.

You may qualify if:

  • The participant population includes young adults (18-25 years of age) who live in Denver, Colorado.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical and Translational Research Center

Boulder, Colorado, 80309, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and fecal samples.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 10, 2019

First Posted

June 14, 2019

Study Start

July 18, 2019

Primary Completion

February 13, 2022

Study Completion

February 13, 2022

Last Updated

December 9, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)