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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | No Intervention | 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. | |
| Viome's Precision Nutrition Program (VPNP) | Active Comparator | 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. |
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| Viome's condition-based supplements | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduced PHQ-9 Score | Reduced PHQ-9 score for both VCS and VPNP groups compared to baseline scores. | ~4 months |
| Reduced GAD-7 Score | Reduced GAD-7 score for both VCS and VPNP groups compared to baseline scores. | ~4 months |
| Reduced Perceived Stress Scale Score | Reduced Perceived Stress Scale score for both VCS and VPNP groups compared to baseline scores. | ~4 months |
| Increased Quality of Life Score | Increased quality of life score for both VCS and VPNP groups compared to baseline scores. | ~4 months |
| Correlation between microbial changes and clinical outcomes | Correlation between microbial changes on VCS or VPNP with clinical outcomes. | ~4 months |
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Inclusion Criteria:
Exclusion criteria
Unwilling to change their current diet
Prior use of Viome products or services
Antibiotic use in the previous 4 weeks
Pregnancy (current or planned in the next 4 months)
< 90 days postpartum
Breast feeding
Active infection
Unable or unwilling to use Viome's App on an iPhone or Android smartphone
Significant diet or lifestyle change in the previous 1 month
IBD diagnosis -Major psychiatric/DSM-4 disease diagnosis (e.g. Schizophrenia, Bipolar disorder, Post- traumatic Stress Disorder, Obsessive Compulsive disorder)
Use of investigational drugs, products or devices within 1 month prior to and 4 months after the start of the trial
Cancer therapy within the previous 1 year
Major surgery in the last 6 months or planned in the next 4 months
Allergies to any supplement ingredients listed in the screening survey
Currently on a specific diet: FODMAP, KETO, PALEO
Answered yes to the question, "In the past few weeks, have you wished you were dead or had thoughts about killing yourself?"
Gastrointestinal disease including:
GI surgery except:
Esophagitis
Celiac disease
GI malignancy or obstruction
Peptic Ulcer Disease
Duodenal or gastric ulcer disease
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| Name | Affiliation | Role |
|---|---|---|
| Momchilo Vuyisich | Viome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Viome Life Sciences | Bothell | Washington | 98011 | United States |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
| D001523 | Mental Disorders |
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Randomized, blinded, cohort study divided into three arms: 1) control group (placebo), 2) condition-based supplement, 3) precision-supplement
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Once enrolled, participants are randomized into one of the three arms. The coded supplements with blinded labels are shipped to the participants. The participants are not aware of which group they are randomized into.
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| VIOME-designed condition-based supplements | Dietary Supplement | Pre-formulated supplements based on overall health conditions. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching. |
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