Viome Nutritional Programs to Improve Clinical Outcomes for Metabolic Conditions

January 27, 2025 updated by: Viome

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Washington
      • Bothell, Washington, United States, 98011
        • Recruiting
        • Viome Life Sciences
        • Contact:
        • Contact:
        • Contact:
          • Momchilo Vuyisich, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of VIOME's designed condition based supplements (VCS)
Time Frame: ~4months
Number of participants that show an improvement in metabolic health compared to baseline survey assessment.
~4months
Efficacy of VIOME Precision Nutrition Program (VPNP)
Time Frame: ~4 months
Number of participants that show an improvement in metabolic health compared to baseline survey assessment.
~4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Viome

Investigators

  • Principal Investigator: Momchilo Vuyisich, Viome Life Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 28, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (Actual)

October 3, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • V211.2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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