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Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

RECRUITINGN/ASponsored by Viome
Actively Recruiting
PhaseN/A
SponsorViome
Started2022-08-22
Est. completion2026-12-13
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Healthy volunteers accepted
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 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 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)

Conditions2

DiabetesPre Diabetes

Locations1 site

Viome Life Sciences
Bothell, Washington, 98011
Momchilo Vuyisich, PhD425-300-6933studies@viome.com

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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