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Dietary Supplement

Viome's Precision Nutrition Program (VPNP) for Diabetes

N/A

Recruiting

Led By Momchilo Vuyisich

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 a medication called VPNP to see if it can lower HbA1c levels. Participants will be recruited directly, without using any other clinics.

Who is the study for?

This trial is for individuals with diabetes interested in seeing if a personalized nutrition program can help lower their HbA1c levels, which is an indicator of blood sugar control. Details on specific inclusion and exclusion criteria are not provided.Check my eligibility

What is being tested?

The study tests Viome's Precision Nutrition Program (VPNP) to see if it effectively reduces HbA1c levels in diabetic patients. It's a randomized trial where participants will be chosen by chance to receive either the VPNP or a placebo.See study design

What are the potential side effects?

Since this trial involves a nutrition program, side effects may include changes in digestion or dietary reactions. However, specific side effects related to Viome's Precision Nutrition Program are not detailed.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

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

Fasting Insulin levels

HbA1c levels

Secondary outcome measures

BMI

Cardiovascular Risk

Cholesterol

+4 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 6.5-8.9% (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 6.5-8.9% (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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

ViomeLead Sponsor

20 Previous Clinical Trials

37,437 Total Patients Enrolled

2 Trials studying Diabetes

2,964 Patients Enrolled for Diabetes

Momchilo VuyisichPrincipal InvestigatorViome

11 Previous Clinical Trials

2,662 Total Patients Enrolled

1 Trials studying Diabetes

52 Patients Enrolled for Diabetes

Frequently Asked Questions

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

Are individuals currently able to apply and participate in this ongoing medical trial?

"Indeed, the available information on clinicaltrials.gov confirms that this trial is actively seeking eligible participants. The initial posting of the study was made on December 13th, 2023 and it underwent its most recent update on December 14th, 2023. The trial aims to enroll a total of 100 candidates from one designated site."

Answered by AI

What is the current number of participants being recruited for this research endeavor?

"Indeed, as indicated on clinicaltrials.gov, this ongoing study is actively seeking eligible participants. The initial posting of the trial was made on December 13th, 2023 and it underwent its most recent update on December 14th, 2023. As part of the recruitment process, the research team aims to enroll a total of 100 patients from a single location."

Answered by AI

What is the primary goal of this medical study?

"The primary aim of this clinical trial, assessed over a span of approximately 4 months, is to examine the impact on Fasting Insulin levels. Secondary objectives include evaluating changes in cholesterol markers such as HDL, LDL, total cholesterol, and triglyceride levels among participants receiving the intervention compared to their initial measurements. Additionally, alterations in species prevalence within stool, blood, and saliva samples will be analyzed relative to baseline data. Lastly, any shifts in waist-to-hip ratio for individuals in the interventional group will be measured against their baseline values."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

2023. "Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06185192.

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