US residents who have mental health issues sign the informed consent form and are screened and enrolled for this study. Participants complete a survey upon enrollment and are randomized into one of two study 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 two study arms including: the placebo arm or the VIOME Precision Nutrition Program (VPNP) arm. Placebo 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.
Viome Life Sciences
Bothell, Washington, United States
RECRUITINGReduced PHQ-9 Score
Reduced PHQ-9 score for the VPNP group compared to baseline scores.
Time frame: ~4 months
Reduced GAD-7 Score
Reduced GAD-7 score for the VPNP groups compared to baseline scores.
Time frame: ~4 months
Reduced Perceived Stress Scale Score
Reduced Perceived Stress Scale score for the VPNP group compared to baseline scores.
Time frame: ~4 months
Increased Quality of Life Score
Increased quality of life score for the VPNP group compared to baseline scores.
Time frame: ~4 months
Correlation between microbial changes and clinical outcomes
Correlation between microbial changes on the VPNP with clinical outcomes.
Time frame: ~4 months
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