Testing a nutrition program to lower blood sugar levels

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled trial aims to evaluate the effectiveness of Viome's Precision Nutrition Program (VPNP) in reducing HbA1c levels in participants with prediabetes or diabetes. Participants will be recruited directly and will undergo a series of assessments, including blood draws and sample collections, at the beginning and end of a 90-day intervention period. They will receive personalized dietary recommendations and supplements based on their individual health data. The study will measure changes in HbA1c levels to determine the efficacy of the program.

Why it matters

Who can join: the full rules

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)

Where it's running

• Viome Life Sciences
  Bothell, Washington, United States Recruiting

Study contacts

• Principal investigator: Momchilo Vuyisich — Viome
• Study coordinator: Mory Mehrtash
• Email: studies@viome.com
• Phone: (425) 300-6933

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.