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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 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 placebo 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 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 | No Intervention | Participants may be provided with any combination of nutritional recommendations and they receive placebo supplements. Placebo capsules will contain inert and inactive materials. The participants are asked to take the supplements on a daily basis. | |
| Viome's Precision Nutrition Program | Active Comparator | Participants may be provided with any combination of nutritional recommendations and supplements. The participants are asked to take the supplements on a daily basis. |
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| Viome's condition-based supplements | Active Comparator | Participants may be provided with any combination of nutritional recommendations and they receive condition based supplements. The participants are asked to take the supplements on a daily basis. |
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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 receive supplements, diet recommendations, and app coaching. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of VIOME's designed condition based supplements (VCS) | Number of participants that show an improvement in metabolic health compared to baseline survey assessment. | ~4months |
| Efficacy of VIOME Precision Nutrition Program (VPNP) | Number of participants that show an improvement in metabolic health compared to baseline survey assessment. | ~4 months |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy Breastfeeding Minors GERD Gastric Ulcers Ulcerative Colitis Crohn's Disease Kidney Impairment (kidney cysts, kidney disease) Liver Condition (gallstones, cholecystitis, cirrhosis, hepatitis, hepatitis a, hepatitis b, hepatitis c, NAFLD/NASH, etc) HIV SIBO CuminAllergy GymnemaAllergy BacopaAllergy CitrusAIlergy LamiaceaeAllergy SageAllergy YeastAllergy MulberryAllergy ChicoryAllergy
FODMAP KETO PALEO
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 Life Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Viome Life Sciences | Recruiting | Bothell | Washington | 98011 | United States |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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 receive supplements, diet recommendations, and app coaching. |
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