Testing a nutrition program to lower blood sugar levels
Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c
This study is testing if a personalized nutrition program can help people with diabetes lower their blood sugar levels over 90 days.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Viome Industry-sponsored |
| Locations | 1 site (Bothell, Washington) |
| Trial ID | NCT06185192 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled trial evaluates the effectiveness of Viome's Precision Nutrition Program (VPNP) in reducing HbA1c levels in participants with diabetes. Eligible individuals 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. Participants will receive personalized dietary recommendations and supplements based on their individual health data. The study aims to determine if these tailored nutrition strategies can significantly lower HbA1c levels compared to a placebo.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with HbA1c levels between 6.5-8.9% who are willing to follow the program's dietary recommendations.
Not a fit: Patients currently using insulin or specific medications to manage diabetes, or those on restrictive diets, may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could provide a personalized approach to managing diabetes and improving blood sugar control.
How similar studies have performed: While personalized nutrition approaches are gaining traction, this specific intervention is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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 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)
Where this trial is running
Bothell, Washington
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.