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Nutritional Intervention

Viome's Precision Nutrition Program (VPNP) for Anxiety

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

No unexplained weight loss, fevers, anemia, or blood in stool

50 years old and older OR BMI of 25 or greater

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

Study Summary

This trial is for people in the US who are obese and agree to participate in the study. Those who are enrolled will be asked to fill out a survey and will be randomly assigned to one of two

Who is the study for?

This trial is for US residents with obesity who are experiencing mental health conditions like anxiety or depression. Participants must understand and sign a consent form, complete an initial survey, and be willing to follow the study procedures without visiting clinical sites.Check my eligibility

What is being tested?

The study is testing the VIOME Precision Nutrition Program against a control arm to see if personalized nutrition can improve mental health outcomes. Participants will be randomly assigned to one of these two groups after enrolling in the study.See study design

What are the potential side effects?

Since this trial involves nutritional programs rather than medication, side effects may include changes in digestion or dietary habits but are not specified as typical drug-related adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I haven't had unexplained weight loss, fevers, anemia, or blood in my stool.

Select...

I am 50 years or older, or my BMI is 25 or more.

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

Change in GAD-7 Score

Change in PHQ-9 Score

Change in Perceived Stress Scale Score

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Viome's Precision Nutrition Program (VPNP)Experimental Treatment1 Intervention

Participants who have mental health issues are randomized into this study 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: PlaceboPlacebo Group1 Intervention

Participants who have mental health issues are randomized into this study 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VIOME Precision Nutrition Program

2020

N/A

~10000

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

ViomeLead Sponsor

20 Previous Clinical Trials

37,477 Total Patients Enrolled

1 Trials studying Anxiety

150 Patients Enrolled for Anxiety

Momchilo VuyisichPrincipal InvestigatorViome

11 Previous Clinical Trials

2,702 Total Patients Enrolled

1 Trials studying Anxiety

150 Patients Enrolled for Anxiety

Frequently Asked Questions

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

Are new participants still being accepted for enrollment in this ongoing research study?

"Indeed, the information on clinicaltrials.gov indicates that this specific clinical trial is actively seeking participants. The trial was initially posted on October 26th, 2023 and underwent its most recent update on January 3rd, 2024. To complete the study successfully, a total of 60 patients will be recruited from one designated location."

Answered by AI

What is the upper limit on the number of participants enrolled in this research endeavor?

"Indeed, the information available on clinicaltrials.gov confirms that this trial is actively seeking eligible candidates. The initial posting date of the clinical trial was October 26th, 2023, and it underwent its most recent edit on January 3rd, 2024. A total of 60 participants will be enrolled at a single location for this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Viome Precision Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions

2023. "Viome Precision Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06190184.

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