Trial studying safety and effects for Diabetes
Official title Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c
ClinicalTrials.gov ID: NCT05465616
What this study is testing
- What it's testing
- This study is testing whether the Precision Nutrition Program can lower HbA1c in people with diabetes or pre-diabetes.
- Who it's for
- You may be able to join if you have diabetes or pre-diabetes.
- What's involved
- You will follow a nutrition plan at home or a pretend plan that has no special changes.
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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.
- 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)
The study team makes the final eligibility decision.
Where it is enrolling
- Bothell, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bothell, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.