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 |
Trial Parameters
Eligibility Fast-Check
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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 pill
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