NCT05465616 · Viome
Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c
What this study is about
This is a randomly assigned, compared against an inactive treatment trial that will test the effectiveness of VPNP in reducing HbA1c. Participant recruitment will occur through direct-to-participant enrollment. No additional clinical sites will be used for recruitment.
View original scientific description
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.
Interventions
DIETARY_SUPPLEMENT
Viome's Precision Nutrition Program (VPNP)
Nutrition, diet, and possible coaching through Viome application. Precision supplement based on the participants microbiome sample results.
Primary outcome measures
HbA1c Levels
Time frame: 4 months
HbA1c changes in individuals in the interventional arm compared to baseline measurement.
Insulin Resistance
Time frame: 4 months
Change in fasting insulin levels in those in the interventional arm compared to baseline measurement.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Bothell, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 24, 2025 · Source of record for eligibility and locations