Viome's Precision Nutrition Program for Diabetes and Pre-Diabetes

This study is testing Viome's Precision Nutrition Program (VPNP) to see if it can help lower HbA1c levels (a measure of blood sugar over time) and improve insulin resistance in people with diabetes or pre-diabetes. VPNP involves personalized nutrition, diet advice, and supplements based on your microbiome (the collection of microbes in your gut). To join, you need to be 18 or older, speak English, and have an HbA1c between 5.7% and 8.9% within the last 30 days. The study will measure your HbA1c and insulin resistance after 4 months to see if the program is successful. The current status of this study is unclear, but it plans to enroll 150 participants.

Study design
This is a randomized, placebo-controlled study, meaning participants will be randomly assigned to receive either the Viome program or a placebo. It aims to enroll 150 participants.
What's involved
You would complete online questionnaires, provide blood, stool, and saliva samples at the beginning and end of the 90-day study period, and follow dietary recommendations and take supplements for 90 days. You will also need to visit a Quest Diagnostic Patient Service Center.
Compensation
Not stated in the trial record.
Follow-up
Your HbA1c levels and insulin resistance will be measured at 4 months after starting the program.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05465616

Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

Recruiting
NAAges 18+InterventionalTreatment
Viome
~150 participants
Updated 2025-01-24 on ClinicalTrials.gov
What's tested:Viome's Precision Nutrition Program (VPNP)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
HbA1c Levels
Measured over 4 months
+1 more outcome measured
Diabetes
Pre Diabetes
1 sites across 1 states
Washington1
  • Momchilo Vuyisich · PRINCIPAL_INVESTIGATOR · Viome

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 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 Nutrition Program
Willing and able to use a smartphone and Viome app.

Exclusion

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)
  • HbA1c Levels4 months

    HbA1c changes in individuals in the interventional arm compared to baseline measurement.

  • Insulin Resistance4 months

    Change in fasting insulin levels in those in the interventional arm compared to baseline measurement.