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

Wellness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06381232
• Other study ID #: VIOME-001
• Status: Recruiting
• Start date: July 23, 2018
• Est. completion date: July 23, 2028

Study information

• Verified date: March 2024
• Source: Viome
• Contact: Momchilo Vuyisich, PhD
• Phone: (425) 300-6933
• Email: studies[@]viome.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: July 23, 2028
• Est. primary completion date: July 23, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• General Health
• Wellness

Intervention

Other:
• No Intervention
This is an observational study, there are no interventions.

Locations

Country	Name	City	State
United States	Viome Life Sciences	Bothell	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Viome

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molecular Determinants of Health and Disease	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