Status:
RECRUITING
Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c
Lead Sponsor:
Viome
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 clinica...
Detailed Description
This is a randomized, placebo-controlled trial that will test the efficacy of VPNP in reducing HbA1c. Participants with HbA1c levels between 6.5-8.9% (inclusive) will be recruited and randomized into ...
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 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
- 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)
Key Trial Info
Start Date :
December 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06185192
Start Date
December 13 2023
End Date
December 1 2026
Last Update
January 29 2025
Active Locations (1)
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1
Viome Life Sciences
Bothell, Washington, United States, 98011