Viome Nutritional Programs to Improve Clinical Outcomes for Metabolic Conditions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Metabolic Health

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. Fasting insulin level >=15 uIU/mL or fasting glucose >= 100 mg/dL within the last 3 months, verified from medical records Exclusion Criteria: Unwilling to change current diet Unwilling to go to Quest Prior use of Viome products or services Antibiotic use in the previous 4 weeks Women who are pregnant (current or planned in the next 4 months), or breastfeeding < 90 days postpartum Active infection Unable or unwilling to use Viome's App on an iPhone or Android smartphone Significant diet or lifestyle changes in the previous 1 month IBD diagnosis 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 Current (or previous) use of medications that increase insulin (sulfonylureas, such as glimepiride, glipizide, glyburide, etc.) Current (or previous) use of exogenous insulin (such as Tresiba, Lantus, Toujeo, Levemir, Humalog, Novolog, Apidra, Fiasp, etc.) Prescribed any drug(s) that may interact with the supplement formulations Have any medical condition or allergy that may interact with, or prevents the healthy consumption of the supplements such as: 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 Allergies to any study-specific supplement ingredients Currently on a specific diet: FODMAP KETO PALEO 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 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. | |
| Active Comparator: Viome's Precision Nutrition Program<br>Participants may be provided with any combination of nutritional recommendations and supplements. The participants are asked to take the supplements on a daily basis. | Combination Product: VIOME Precision Nutrition Program<br>* Precision supplement based on the participants microbiome sample results. Participants in this arm may receive supplements, diet recommendations, and app coaching.<br>* Other names: VPNP;|
| Active Comparator: Viome's condition-based supplements<br>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. | Dietary Supplement: VIOME-designed condition-based supplements<br>* Pre-formulated supplements based on overall health conditions. Participants in this arm may receive supplements, diet recommendations, and app coaching.<br>* Other names: VCS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMI, Framingham Risk Score, Insulin, blood glucose, HbA1c, hsCRP, Lipids, Supplements, Vitamins, diet