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Nutritional Intervention

Precision Nutrition for Mental Health

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

Must not have

IBD diagnosis

Active infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

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.

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.

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with inflammatory bowel disease (IBD).

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I currently have an infection.

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I haven't used any experimental drugs or devices in the last month.

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I have used Viome products or services before.

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I have been diagnosed with a major psychiatric disorder like schizophrenia or bipolar disorder.

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I have not had cancer treatment in the last year.

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I haven't had major surgery in the past 6 months and don't plan any in the next 4 months.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 / 9Eligibility criteria met