Testing a nutrition program to lower blood sugar levels
Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c
NA · Viome · NCT05465616
This study is testing a personalized nutrition program to see if it can help people with prediabetes or diabetes lower their blood sugar levels over 90 days.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Viome (industry) |
| Locations | 1 site (Bothell, Washington) |
| Trial ID | NCT05465616 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with HbA1c levels between 5.7-8.9% who are willing to follow the program's dietary recommendations.
Not a fit: Patients currently using insulin or specific medications to manage blood sugar levels may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could provide a personalized approach to managing blood sugar levels, potentially reducing the risk of diabetes complications.
How similar studies have performed: Other studies have shown promise in using personalized nutrition approaches to manage diabetes, suggesting potential for success in this trial.
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 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 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.
Conditions: Diabetes, Pre Diabetes, Health, Wellness, Nutrition, Vitamins, Supplements, Prebiotics