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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 25 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized, blinded, cohort study divided into three arms: 1) control group (placebo), 2) condition-based supplement, 3) precision-supplement
Primary Purpose
Treatment
Masking
Single (Participant)
Masking Description
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.

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Placebo 		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 		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
    Precision supplement based on the participants microbiome sample results. Participants in this arm may receive supplements, diet recommendations, and app coaching.
    Other names:
    • VPNP
Active Comparator
Viome's condition-based supplements 		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
    Pre-formulated supplements based on overall health conditions. Participants in this arm may receive supplements, diet recommendations, and app coaching.
    Other names:
    • VCS

Recruiting Locations

Viome Life Sciences
Bothell, Washington 98011
Contact:
Momchilo Vuyisich
(425) 300-6933
studies@viome.com

More Details

Status
Recruiting
Sponsor
Viome

Study Contact

Mory Mehrtash
(425) 300-6933
studies@viome.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.