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ObesityHYPHYNCT03986814

Environmental Health Effects on Your Physiology

An observational study of Obesity, run by University of Colorado, Boulder at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 25 years
Conditions the study is for
Obesity
How many people
92 participants
Where
1 siteUnited States
Study dates
18 Jul 2019to 13 Feb 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • All sexes
  • Adult

Study population: Young adults from Denver, Colorado.

Who may be able to join

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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Clinical and Translational Research Center

    Boulder, Colorado, 80309

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Obesity
Medical subject headings
Obesity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gut Microbiome

    16S rRNA and Shotgun Sequencing

    Measured: Measured once at baseline visit date

  2. Fecal Metabolome

    Targeted and/or Un-targeted Metabolomics

    Measured: Measured once at baseline visit date

  3. Body mass index (BMI)

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

    Measured: Measured once at baseline visit date

  4. Body Composition

    Waist and hip measurements will be taken

    Measured: Measured once at baseline visit date

Secondary outcomes (7)

  1. Air Pollution

    Modeled residential exposure to air pollution

    Measured: One year before baseline visit date

  2. Green Space

    Modeled residential exposure to green space

    Measured: One year before baseline visit date

  3. Serum Metabolome

    Targeted and/or Un-targeted Metabolomics

    Measured: Measured once at baseline visit date

  4. Diet

    Automated Self-Administered 24-Hour (ASA24)

    Measured: Measured once at baseline

  5. Physical Activity

    International Physical Activity Questionnaire

    Measured: Measured once at baseline

  6. Fasting Glucose

    Fasting Glucose (mg/dl)

    Measured: Measured once at baseline

  7. Fasting Insulin

    Fasting insulin (uU/mL)

    Measured: Measured once at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2019
  2. Study start18 Jul 2019
  3. Primary completion13 Feb 2022
  4. Study completion13 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03986814
Sponsor's protocol ID
19-0201
Acronym
HYPHY
Status last verified
Dec 2024
First submitted
10 Jun 2019
Last updated
9 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by University of Colorado, Boulder at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gut Microbiome (time frame: Measured once at baseline visit date). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03986814.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.

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