NCT05465616 Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c
| NCT ID | NCT05465616 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Viome |
| Condition | Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2022-08-22 |
| Primary Completion | 2026-12-13 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2022-08-22 with a primary completion date of 2026-12-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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)
Contact & Investigator
Momchilo Vuyisich
PRINCIPAL INVESTIGATOR
Viome
Frequently Asked Questions
Who can join the NCT05465616 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05465616 currently recruiting?
Yes, NCT05465616 is actively recruiting participants. Contact the research team at studies@viome.com for enrollment information.
Where is the NCT05465616 trial being conducted?
This trial is being conducted at Bothell, United States.
Who is sponsoring the NCT05465616 clinical trial?
NCT05465616 is sponsored by Viome. The principal investigator is Momchilo Vuyisich at Viome. The trial plans to enroll 150 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.