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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
Precision supplement based on the participants microbiome sample results. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.
Pre-formulated supplements based on overall health conditions. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.
Viome Life Sciences
Bothell, Washington, United States
Reduced PHQ-9 Score
Reduced PHQ-9 score for both VCS and VPNP groups compared to baseline scores.
Time frame: ~4 months
Reduced GAD-7 Score
Reduced GAD-7 score for both VCS and VPNP groups compared to baseline scores.
Time frame: ~4 months
Reduced Perceived Stress Scale Score
Reduced Perceived Stress Scale score for both VCS and VPNP groups compared to baseline scores.
Time frame: ~4 months
Increased Quality of Life Score
Increased quality of life score for both VCS and VPNP groups compared to baseline scores.
Time frame: ~4 months
Correlation between microbial changes and clinical outcomes
Correlation between microbial changes on VCS or VPNP with clinical outcomes.
Time frame: ~4 months
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