Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

Last updated: January 21, 2025
Sponsor: Viome
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Diabetic Gastroparesis

Diabetes And Hypertension

Treatment

Viome's Precision Nutrition Program (VPNP)

Clinical Study ID

NCT05465616
V197
  • Ages > 18
  • All Genders

Study Summary

This is a randomized, placebo-controlled trial that will test the efficacy of VPNP in reducing HbA1c. Participant recruitment will occur through direct-to-participant enrollment. No additional clinical sites will be used for recruitment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed and dated informed consent form and medical release prior to anytrial-specific procedures are performed

  • Females and males aged 18 years or older

  • Able to speak and read English

  • HbA1c between 5.7-8.9% (inclusive), tested within the past 30 days

  • Willing and able to visit a Quest Diagnostic Patient Service Center (PSC)

  • Willing and able to follow the trial instructions and Viome's Precision NutritionProgram

  • Willing and able to use a smartphone and Viome app.

Exclusion

Exclusion Criteria:

  • Antibiotic use within one month of the GI test

  • Gestation within previous 6 month

  • Current (or previous) use of medications that increase insulin (sulfonylureas, suchas glimepiride, glipizide, glyburide, etc.)

  • Current (or previous) use of exogenous insulin (such as Tresiba, Lantus, Toujeo,Levemir, Humalog, Novolog, Apidra, Fiasp, etc.)

  • On a specific diet, such as ketogenic, for the purpose of reducing HbA1c and/orweight within the previous month

  • Taking diet pills

  • Allergy to an ingredient in the MH capsule or stick pack

  • Currently on an investigational product

  • Significant surgery or medical procedure planned

  • Diet or lifestyle change during the trial period, besides those appropriate fortrial arm Has followed Viome nutritional recommendations (foods and/or supplements)

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Viome's Precision Nutrition Program (VPNP)
Phase:
Study Start date:
August 22, 2022
Estimated Completion Date:
December 13, 2026

Study Description

This is a randomized, placebo-controlled trial that will test the efficacy of VPNP in reducing HbA1c. Participants with HbA1c levels between 5.7-8.9% (inclusive) will be recruited and randomized into either the placebo or intervention group. The study duration for each participant will be approximately 90 days. At the beginning of the 90 days, the participant will complete online questionnaires, a blood draw, and a set of at-home sample collections for blood, stool, and saliva that will be sent back to Viome. After the samples are analyzed, the participant will receive dietary recommendations (either personalized or USDA) and supplements (either personalized or placebo). The participant will follow the dietary recommendations and take the supplements for 90 days. At the end of the 90 days, the participant will once again complete online questionnaires, a blood draw, and a set of at-home sample collections for blood, stool, and saliva that will be sent back to Viome for analysis.

Connect with a study center

  • AdventHealth

    Orlando, Florida 32804
    United States

    Site Not Available

  • Viome Life Sciences

    Bothell, Washington 98011
    United States

    Active - Recruiting

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