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Dietary Supplement

Viome's Precision Nutrition Program (VPNP) for Prediabetes

N/A
Waitlist Available
Led By Saadia Alvi, MD
Research Sponsored by Viome
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing and able to use a smartphone and Viome app.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights

Study Summary

This trial will test if a drug called VPNP can help reduce HbA1c levels. People will be randomly assigned to take either the drug or a placebo, and AdventHealth in Orlando, FL will be recruiting participants.

Who is the study for?
This trial is for English-speaking adults aged 18 or older with HbA1c levels between 5.7% and 8.9%. Participants must be able to visit a Quest Diagnostics center, follow the nutrition program, use a smartphone with Viome's app, and not have used certain diabetes medications or been on specific diets recently.Check my eligibility
What is being tested?
The trial is testing Viome's Precision Nutrition Program (VPNP) to see if it can lower HbA1c in people with diabetes or prediabetes. It's randomized and placebo-controlled, meaning some people will get VPNP while others won't, decided by chance.See study design
What are the potential side effects?
Since this trial involves a nutrition program rather than medication, side effects may include changes in digestion or potential food allergies related to new diet components within the program.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can use a smartphone and the Viome app.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
HbA1c Levels
Insulin Resistance
Secondary outcome measures
BMI
Cardiovascular Risk
Cholesterol
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Viome's Precision Nutrition Program (VPNP)Experimental Treatment1 Intervention
Participants with HbA1c levels between 5.7-8.9% (inclusive) are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Participants may need to use a mobile app in order to participate in the trial.
Group II: PlaceboActive Control1 Intervention
Participants with HbA1c levels between 5.7-8.9% (inclusive) are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Placebo capsules will contain inert and inactive materials. Participants may need to use a mobile app in order to participate in the trial.

Find a Location

Who is running the clinical trial?

ViomeLead Sponsor
19 Previous Clinical Trials
17,485 Total Patients Enrolled
Saadia Alvi, MDPrincipal InvestigatorAdventHealth
Momchilo VuyisichPrincipal InvestigatorViome
11 Previous Clinical Trials
2,710 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What site did they apply to?
AdventHealth
Viome Life Sciences
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

To see if I can get off meds all together.
PatientReceived 1 prior treatment
~18 spots leftby Apr 2025