Viome Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions

Study Overview
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Brief Summary
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US residents who have gastrointestinal 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.

Detailed Description
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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 gastrointestinal wellness. The trial will last approximately 4 months for each participant.

Official Title
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Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Mental Health Conditions

Conditions
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Mental Health, Depression, Anxiety

Intervention / Treatment
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* Combination Product: VIOME Precision Nutrition Program
* Dietary Supplement: VIOME-designed condition-based supplements


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Resident of the United States Females and males ages 25-75 (inclusive) Able to speak and read English No unexplained weight loss, fevers, anemia, or blood in stool Willing and able to follow the trial instructions, as described in the recruitment letter Signed and dated informed consent prior to any trial-specific procedures. PHQ9 score of 5-24 (inclusive) 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: Appendectomy and benign polypectomy Esophagitis Celiac disease GI malignancy or obstruction Peptic Ulcer Disease Duodenal or gastric ulcer disease

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, blinded, cohort study divided into three arms: 1) control group (placebo), 2) condition-based supplement, 3) precision-supplement
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Placebo<br>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 and inactive materials. Participants may need to use a mobile app in order to participate in the trial. | |
| Active Comparator: Viome's Precision Nutrition Program (VPNP)<br>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<br>* Precision supplement based on the participants microbiome sample results. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.<br>* Other names: VPNP;|
| Active Comparator: Viome's condition-based supplements<br>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<br>* Pre-formulated supplements based on overall health conditions. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.<br>* Other names: VCS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mental health, diet, supplements, vitamins, stress