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Nutritional Therapy

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

Females and males ages 25-75 (inclusive)

Must not have

Prior use of Viome products or services

Major surgery in the last 6 months or planned in the next 4 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ~4 months

Awards & highlights

No Placebo-Only Group

Summary

This trial involves US residents with mental health problems who sign a form to join the study. They fill out a survey and are placed into one of two groups. The study is done remotely and does not

Who is the study for?

This trial is for US residents with mental health issues like anxiety or depression. Participants must be willing to sign an informed consent form and complete a survey upon enrollment.

What is being tested?

The VIOME Precision Nutrition Program is being tested to see if it can improve outcomes for people with mental health disorders. Participants are randomly placed into one of two groups in this direct-to-participant study without clinical sites.

What are the potential side effects?

Since the intervention involves nutritional programs, side effects may vary widely based on individual reactions but could include digestive changes or food sensitivities.

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 between 25 and 75 years old.

Exclusion Criteria

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

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I have used Viome products or services before.

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

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

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I have not had cancer treatment in the last year.

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I currently have an active infection.

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I do not have major GI diseases or recent surgeries except for appendectomy or benign polypectomy.

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

Correlation between microbial changes and clinical outcomes

Increased Quality of Life Score

Reduced GAD-7 Score

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: PlaceboActive Control1 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 or inactive ingredients. Participants may need to use a mobile app in order to participate in the trial.

Group II: Viome's Precision Nutrition Program (VPNP)Active Control1 Intervention

Participants who have mental health issues 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.

0 / 8Eligibility criteria met