An interventional study of VIOME Precision Nutrition Program and VIOME-designed condition-based supplements in Mental Health, Depression and Anxiety, sponsored by Viome. Active, not recruiting at 1 site in United States. Open to participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by Viome · Not applicable, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 150 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Viome is the lead sponsor of 24 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria
Gastrointestinal disease including:
GI surgery except:
Participants who have mental health issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Placebo capsules will contain inert or inactive ingredients. Participants may need to use a mobile app in order to participate in the trial.
Participants who have mental health issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Participants may need to use a mobile app in order to participate in the trial.
Combination Product: VIOME Precision Nutrition Program
Participants who have mental health issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Participants may need to use a mobile app in order to participate in the trial.
Dietary Supplement: VIOME-designed condition-based supplements
Precision supplement based on the participants microbiome sample results. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.
Also known as: VPNP
Pre-formulated supplements based on overall health conditions. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.
Also known as: VCS
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
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Viome