Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

Viome

Status: Enrolling

Conditions: Diabetes

Treatments: Dietary Supplement: Viome's Precision Nutrition Program (VPNP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06185192

V197.1

Details and patient eligibility

About

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.

Full 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 either the placebo or intervention group. The study duration for each participant will be approximately 90 days. At the beginning of the 90 days, the participant will complete online questionnaires, a blood draw, and a set of at-home sample collections for blood, stool, and saliva that will be sent back to Viome. After the samples are analyzed, the participant will receive dietary recommendations and either personalized supplements or placebo supplements. The participant will follow the dietary recommendations and take the supplements for 90 days. At the end of the 90 days, the participant will once again complete online questionnaires, a blood draw, and a set of at-home sample collections for blood, stool, and saliva that will be sent back to Viome for analysis.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Placebo

No Intervention group

Description:

Participants with HbA1c levels between 6.5-8.9% (inclusive) are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Placebo capsules will contain inert and inactive materials. Participants may need to use a mobile app in order to participate in the trial.

Viome's Precision Nutrition Program (VPNP)

Experimental group

Description:

Participants with HbA1c levels between 6.5-8.9% (inclusive) are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Participants may need to use a mobile app in order to participate in the trial.

Treatment:

Dietary Supplement: Viome's Precision Nutrition Program (VPNP)