Viome Precision Nutritional Programs to Improve Clinical Outcomes for Mental Health Disorders
Part of paid clinical trials in Bothell, Washington.
- Sponsor
- Viome
- Study ID
- NCT06502717
- Status
- Recruiting
Conditions
- Anxiety
- Depression
- Mental Health Issue
Eligibility Criteria
- Sex
- ALL
- Age
- 25 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- VIOME Precision Nutrition Program — COMBINATION_PRODUCTPrecision supplement based on the participants microbiome sample results. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.
Study Details
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.
Key Dates
- Start date
- Jul 8, 2024
- Status verified
- Jun 2024
- Primary completion
- Dec 31, 2025
- Completion
- Dec 31, 2025
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- No Intervention: PlaceboParticipants who have mental health issues are randomized into this study 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.
- Active Comparator: Viome's Precision Nutrition Program (VPNP)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.
Primary Outcome Measure
Reduced PHQ-9 Score [ Time Frame: ~4 months ]
Central Contacts
- Mory Mehrtash(425) 300-6933
- Momchilo Vuyisich(425) 300-6933
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Viome Life Sciences | Bothell | Washington | 98011 | Momchilo Vuyisich, PhD (PRINCIPAL_INVESTIGATOR) |
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