Trials / Unknown
UnknownNCT06190184
Viome Precision Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions
Testing the Efficacy of Viome Precision Supplements to Improve Clinical Outcomes for Mental Health Conditions
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Viome · Industry
- Sex
- All
- Age
- 25 Years
- Healthy volunteers
- Not accepted
Summary
US residents who have obesity and 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 two arms. This study is direct to participant and will not utilize clinical sites.
Detailed description
Participants who meet the eligibility criteria are randomized into any of the two arms including: the placebo arm or the VIOME Precision Nutrition Program (VPNP) arm. Placebo and Viome's Precision Nutrition Program include supplements and/or dietary recommendations towards improving the symptoms associated with metabolic wellness. The trial will last approximately 4 months for each participant.
Conditions
- Mental Health Issue
- Mental Health Disorder
- Mental Health
- Depression
- Depression, Anxiety
- Anxiety
- Anxiety Disorders
- Anxiety Depression
- Anxiety State
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | VIOME Precision Nutrition Program | Precision supplement based on the participants microbiome sample results. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching. |
| OTHER | Control arm | Participants who have mental health issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and/or supplements. Placebo capsules will contain inert and inactive materials. Participants may need to use a mobile app in order to participate in the trial. |
Timeline
- Start date
- 2023-10-26
- Primary completion
- 2024-10-31
- Completion
- 2024-12-31
- First posted
- 2024-01-05
- Last updated
- 2024-01-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06190184. Inclusion in this directory is not an endorsement.