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

Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Mental Health Conditions

US residents who have mental health issues sign the informed consent form and are screened and enrolled for this study. Participants complete a survey upon enrollment and are randomized into one of two study arms. This study is direct to participant and will NOT utilize clinical sites.

Study Overview

• Status: Recruiting
• Conditions: Depression; Anxiety; Mental Health Issue
• Intervention / Treatment: Combination product: VIOME Precision Nutrition Program

Detailed Description

Participants who meet the eligibility criteria are randomized into any of the two study arms including: the placebo arm or the VIOME Precision Nutrition Program (VPNP) arm.

Placebo and Viome's Precision Nutrition Program include supplements, may include dietary recommendations towards improving the symptoms associated with mental health. The trial will last approximately 4 months for each participant.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Momchilo Vuyisich; Phone Number: (425) 300-6933; Email: studies@viome.com
• Study Contact Backup: Name: Mory Mehrtash; Phone Number: (425) 300-6933; Email: studies@viome.com

Study Locations

• United States
  • Washington
    • Bothell, Washington, United States, 98011
      • Recruiting
      • Viome Life Sciences
      • Contact: Mory Mehrtash, MSHS; Phone Number: (425) 300-6933; Email: studies@viome.com
      • Contact: Momchilo Vuyisich, PhD; Phone Number: (425) 300-6933; Email: studies@viome.com
      • Contact: Momchilo Vuyisich, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Viome's Precision Nutrition Program (VPNP); 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.	Combination product: VIOME Precision Nutrition Program; Precision supplement based on the participants microbiome sample results. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.; Other Names: VPNP
No Intervention: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced PHQ-9 Score	Reduced PHQ-9 score for the VPNP group compared to baseline scores.	~4 months
Reduced GAD-7 Score	Reduced GAD-7 score for the VPNP groups compared to baseline scores.	~4 months
Reduced Perceived Stress Scale Score	Reduced Perceived Stress Scale score for the VPNP group compared to baseline scores.	~4 months
Increased Quality of Life Score	Increased quality of life score for the VPNP group compared to baseline scores.	~4 months
Correlation between microbial changes and clinical outcomes	Correlation between microbial changes on the VPNP with clinical outcomes.	~4 months

Collaborators and Investigators

• Sponsor: Viome
• Investigators: Principal Investigator: Momchilo Vuyisich, Viome

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: mental health; stress; diet; supplements; vitamins
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: V211.3_v2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No