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

Eligibility Criteria

Sex
ALL
Age
25 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • VIOME Precision Nutrition Program — COMBINATION_PRODUCT
    Precision 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: Placebo
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
Viome Life SciencesBothellWashington98011
Momchilo Vuyisich, PhD
(425) 300-6933
Mory Mehrtash, MSHS
(425) 300-6933
Momchilo Vuyisich, PhD (PRINCIPAL_INVESTIGATOR)

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