Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c
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.
Conditions:
🦠 Diabetes
🗓️ Study Start (Actual) 13 December 2023
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) September 2025
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Bothell, Washington, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Signed and dated informed consent form and medical release prior to any trial-specific procedures are performed
    • * Females and males aged 18 years or older
    • * Able to speak and read English
    • * HbA1c between 6.5-8.9% (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 Nutrition Program
    • * Willing and able to use a smartphone and Viome app.

    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, such as 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/or weight 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 for trial arm Has followed Viome nutritional recommendations (foods and/or supplements)
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 14 December 2023
  • First Submitted that Met QC Criteria 14 December 2023
  • First Posted 29 December 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 2 January 2024
  • Last Update Posted 5 January 2024
  • Last Verified January 2024