Actively Recruiting
Efficacy of Viome's Precision Nutrition Program for Lowering HbA1c in Adults with Diabetes or Prediabetes A Randomized Placebo-Controlled Trial
Led by Viome · Updated on 2025-01-24
150
Participants Needed
1
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of Viome's Precision Nutrition Program (VPNP) in lowering HbA1c levels in adults with diabetes or prediabetes. This randomized, placebo-controlled trial recruits participants with HbA1c levels between 5.7% and 8.9%. The study is conducted entirely through direct-to-participant enrollment without additional clinical sites. Participants will be randomized to receive either personalized dietary recommendations and supplements based on their microbiome analysis or standard USDA dietary guidance with placebo supplements. At the start of the 90-day study, participants complete online questionnaires and provide blood, stool, and saliva samples both at home and through a blood draw. After analysis, participants follow their assigned nutrition plan and take supplements for 90 days. Throughout the study, participants will be monitored via questionnaires and repeat sample collections at the end of the 90 days. The study measures changes in HbA1c and insulin resistance to assess the program's impact. Participants must be willing and able to use a smartphone app and visit a Quest Diagnostic center for blood draws as part of their involvement.
CONDITIONS
Official Title
Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and medical release before trial procedures
- Female or male aged 18 years or older
- Able to read and speak English
- HbA1c between 5.7% and 8.9% tested within 30 days
- Willing and able to visit a Quest Diagnostic Patient Service Center
- Willing and able to follow trial instructions and Viome's Precision Nutrition Program
- Willing and able to use a smartphone and Viome app
You will not qualify if you...
- Antibiotic use within one month before GI test
- Pregnancy within previous 6 months
- Current or previous use of insulin-increasing medications like sulfonylureas
- Current or previous use of exogenous insulin
- Following a specific diet (such as ketogenic) to reduce HbA1c or weight within the past month
- Taking diet pills
- Allergy to any ingredient in study capsules or stick packs
- Currently using an investigational product
- Planned significant surgery or medical procedure
- Diet or lifestyle change during the trial period except those in trial arms
- Prior adherence to Viome nutritional recommendations (foods or supplements)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Viome Life Sciences
Bothell, Washington, United States, 98011
Actively Recruiting
Research Team
M
Mory Mehrtash
M
Momchilo Vuyisich
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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