Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

Launched by VIOME · Jul 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of Viome's Precision Nutrition Program (VPNP) in helping to lower blood sugar levels, specifically a measurement called HbA1c, in people with diabetes or pre-diabetes. The trial involves participants who are randomly assigned to either follow the nutrition program or receive a placebo (a product that looks like the treatment but doesn't have any active ingredients). This means that some people will be actively trying the program while others will not, allowing researchers to see if the program really works.

To participate, you need to be at least 18 years old, able to read and speak English, and have an HbA1c level between 5.7% and 8.9%, which was tested in the last month. You should also be comfortable using a smartphone and the Viome app. Participants will visit a specific location for some tests and must agree to follow the trial’s guidelines. It's important to note that certain conditions, like recent antibiotic use or specific diabetes medications, may exclude you from participating. If you join, you can expect to learn more about your health and receive guidance on nutrition tailored to help manage your blood sugar levels.

Gender

ALL

Eligibility criteria

• 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)