Viome Precision Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions

NCT06190184 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-01-05

No results posted yet for this study

Summary

US residents who have obesity and sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of two arms. This study is direct to participant and will not utilize clinical sites.

Conditions

Interventions

COMBINATION_PRODUCT

VIOME Precision Nutrition Program

Precision supplement based on the participants microbiome sample results. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.

OTHER

Control arm

Participants who have mental health issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and/or supplements. Placebo capsules will contain inert and inactive materials. Participants may need to use a mobile app in order to participate in the trial.

Sponsors & Collaborators

  • Viome

    lead INDUSTRY

Principal Investigators

  • Momchilo Vuyisich · Viome

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-26
Primary Completion
2024-10-31
Completion
2024-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06190184 on ClinicalTrials.gov