NCT05563857

Viome Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions

Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Mental Health Conditions

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Viome · Industry
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

US residents who have mental health issues 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 three arms. This study is direct to participant and will NOT utilize clinical sites.

Detailed description

Participants who meet the eligibility criteria are randomized into any of the three arms including: the control arm, VIOME's condition-based supplements (VCS) arm or the VIOME Precision Nutrition Program (VPNP) arm. Placebo, Viome-designed condition-based supplements and Viome's Precision Nutrition Program include supplements, may include dietary recommendations towards improving the symptoms associated with mental health. The trial will last approximately 4 months for each participant.

Conditions

• Mental Health
• Depression
• Anxiety

Interventions

Type	Name	Description
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.
DIETARY_SUPPLEMENT	VIOME-designed condition-based supplements	Pre-formulated supplements based on overall health conditions. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.

Timeline

• Start date: 2022-10-19
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-10-03
• Last updated: 2025-01-29

Locations

1 site across 1 country: United States