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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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 and inactive materials. Participants may need to use a mobile app in order to participate in the trial. |
|
| Viome's Precision Nutrition Program (VPNP) | Experimental | Participants who have mental health issues are randomized into this study 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. |
|
| 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 |
|---|---|---|
| Change in PHQ-9 Score | Change in PHQ-9 score for VPNP group compared to baseline scores. | 4 months |
| Change in GAD-7 Score | Change in GAD-7 score for VPNP group compared to baseline scores. | 4 months |
| Change in Quality of Life Score | Change in quality of life score for VPNP group compared to baseline scores. | 4 months |
| Change in Perceived Stress Scale Score | Change in perceived stress score for VPNP group compared to baseline scores. | 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 | Role | Phone | Extension | |
|---|---|---|---|---|
| Mory Mehrtash | Contact | (425) 300-6933 | studies@viome.com | |
| Momchilo Vuyisich | Contact | (425) 300-6933 | studies@viome.com |
| Name | Affiliation | Role |
|---|---|---|
| Momchilo Vuyisich | Viome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Viome Life Sciences | Recruiting | Bothell | Washington | 98011 | United States |
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Randomized, blinded, cohort study divided into two study arms: 1) control group (placebo), 2) precision-supplement
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Once enrolled, participants are randomized into one of the 2 study 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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| Control arm | Other | 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. |
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|
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D000092862 | Psychological Well-Being |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
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