RecruitingNot ApplicableNCT05465616

Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

Sponsor

Viome

Enrollment

150 participants

Start Date

Aug 22, 2022

Study Type

INTERVENTIONAL

Conditions

Diabetes Pre-diabetes

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria10

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)