Collection and Analyses of Physiological, Physical, and Molecular Data From a Diverse Population

April 18, 2024 updated by: Viome
The purpose of the study is to collect and analyze physiological, physical, and molecular data from a diverse population to increase our understanding of how such parameters are associated with health and disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The analyses conducted by Viome will include, but are not limited to: genetic, transcriptomic, metabolomic, physiological, and physical. The samples collected from participants may include any of these: stool, blood, saliva, cheek swab, vaginal, breast milk/colostrum, nasal swabs or washes, and urine.

Study participants will collect the clinical samples and ship them to Viome labs or CROs (Contract Research Organizations), where they will be analyzed.

The objective of the study is to establish which foods correspond with increased wellness, and which foods correspond to decreased wellness.

The study hypothesis is that by monitoring the patterns of food intake and lifestyle parameters, in conjunction with non-invasive sample testing, personalized diet and lifestyle recommendations can be elucidated.

Study Type

Observational

Enrollment (Estimated)

20000

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

Study Locations

  • United States
    • Washington
      • Bothell, Washington, United States, 98011
        • Recruiting
        • Viome Life Sciences
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Participants with specific phenotypes of interest and matched healthy controls.

Description

Inclusion Criteria:

  • Anyone that resides in the US at the time of enrollment.

Exclusion Criteria:

  • None

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Control
Other: No Intervention
This is an observational study, there are no interventions.
Cases (Various Phenotypes)
Other: No Intervention
This is an observational study, there are no interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Molecular Determinants of Health and Disease
Time Frame: 10 years
We measure thousands of transcript levels in multiple clinical samples. The primary outcome measures are changes in quantitative gene expression, microbial or human, as a result of transitioning from a healthy state to a disease.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Viome

Investigators

  • Principal Investigator: Momchilo Vuyisich, PhD, Viome

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 23, 2018

Primary Completion (Estimated)

July 23, 2028

Study Completion (Estimated)

July 23, 2028

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • VIOME-001

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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