Viome Nutritional Programs to Improve Clinical Outcomes for Metabolic Conditions

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.

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