Viome Nutritional Programs to Improve Clinical Outcomes for Metabolic Conditions

Viome

Status: Enrolling

Conditions: Metabolic Health

Treatments: Dietary Supplement: VIOME-designed condition-based supplements; Combination Product: VIOME Precision Nutrition Program

Study type: Interventional

Funder types: Industry

Identifiers

NCT05564273

V211.2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Placebo

No Intervention group

Description:

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 group

Description:

Participants may be provided with any combination of nutritional recommendations and supplements. The participants are asked to take the supplements on a daily basis.

Treatment:

Combination Product: VIOME Precision Nutrition Program

Viome's condition-based supplements

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: VIOME-designed condition-based supplements