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Viome Precision Nutritional Programs for Mental Health

This study is testing the Viome Precision Nutrition Program to see if it can help improve symptoms of mental health issues like depression and anxiety. You might be able to join if you are a US resident between 25 and 75 years old, can read English, and have no unexplained weight loss, fevers, anemia, or blood in your stool. The study will measure success by looking at changes in your PHQ-9 (a depression questionnaire), GAD-7 (an anxiety questionnaire), and Perceived Stress Scale scores after about four months. The current status of this study is unclear, but it plans to enroll 150 participants.

Study design
This study is interventional and will randomize participants into one of two groups: a placebo group or the Viome Precision Nutrition Program group. It aims to enroll 150 participants.
What's involved
You will complete a survey upon enrollment and follow trial instructions for approximately 4 months. This study is direct to participant and will not use clinical sites.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be measured at approximately 4 months after starting the program.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06502717

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

UNKNOWN
NAAges 25–75InterventionalTreatment
Viome
~150 participants
Updated 2025-01-29 on ClinicalTrials.gov
What's tested:VIOME Precision Nutrition Program

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Reduced PHQ-9 Score
Measured over ~4 months
+4 more outcomes measured

Conditions

Mental Health Issue
Depression
Anxiety

Explore related trials

AnxietyDepressionPsychiatric Disorder

Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Momchilo Vuyisich · PRINCIPAL_INVESTIGATOR · Viome

Who to contact

Mory Mehrtash
[email protected]
(425) 300-6933
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Resident of the United States
Females and males ages 25-75 (inclusive)
Able to speak and read English
No unexplained weight loss, fevers, anemia, or blood in stool
Willing and able to follow the trial instructions, as described in the recruitment letter
Signed and dated informed consent prior to any trial-specific procedures.
PHQ9 score of 5-24 (inclusive)

Exclusion

Unwilling to change their current diet
Prior use of Viome products or services
Antibiotic use in the previous 4 weeks
Pregnancy (current or planned in the next 4 months)
\< 90 days postpartum
Breast feeding
Active infection
Unable or unwilling to use Viome's App on an iPhone or Android smartphone
Significant diet or lifestyle change in the previous 1 month
IBD diagnosis -Major psychiatric/DSM-4 disease diagnosis (e.g. Schizophrenia, Bipolar disorder, Post- traumatic Stress Disorder, Obsessive Compulsive disorder)
Use of investigational drugs, products or devices within 1 month prior to and 4 months after the start of the trial
Cancer therapy within the previous 1 year
Major surgery in the last 6 months or planned in the next 4 months
Allergies to any supplement ingredients listed in the screening survey
Currently on a specific diet: FODMAP, KETO, PALEO
Answered yes to the question, "In the past few weeks, have you wished you were dead or had thoughts about killing yourself?"
Gastrointestinal disease including:
GI surgery except:
Appendectomy and benign polypectomy
Esophagitis
Celiac disease
GI malignancy or obstruction
Peptic Ulcer Disease
Duodenal or gastric ulcer disease

What this trial measures

  • Reduced PHQ-9 Score~4 months

    Reduced PHQ-9 score for the VPNP group compared to baseline scores.

  • Reduced GAD-7 Score~4 months

    Reduced GAD-7 score for the VPNP groups compared to baseline scores.

  • Reduced Perceived Stress Scale Score~4 months

    Reduced Perceived Stress Scale score for the VPNP group compared to baseline scores.

  • Increased Quality of Life Score~4 months

    Increased quality of life score for the VPNP group compared to baseline scores.

  • Correlation between microbial changes and clinical outcomes~4 months

    Correlation between microbial changes on the VPNP with clinical outcomes.