Viome Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions

NCT05563857 | Active Not Recruiting

• 1 other identifier: V211.3
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mental Health; Depression; Anxiety

Keywords

mental health; diet; supplements; vitamins; stress

Outcome Measures

Primary Outcomes (5)

• Reduced PHQ-9 Score

  Reduced PHQ-9 score for both VCS and VPNP groups compared to baseline scores.

  ~4 months

• Reduced GAD-7 Score

  Reduced GAD-7 score for both VCS and VPNP groups compared to baseline scores.

  ~4 months

• Reduced Perceived Stress Scale Score

  Reduced Perceived Stress Scale score for both VCS and VPNP groups compared to baseline scores.

  ~4 months

• Increased Quality of Life Score

  Increased quality of life score for both VCS and VPNP groups compared to baseline scores.

  ~4 months

• Correlation between microbial changes and clinical outcomes

  Correlation between microbial changes on VCS or VPNP with clinical outcomes.

  ~4 months

Study Arms (3)

Placebo

NO INTERVENTION

Participants who have mental health issues are randomized into this 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.

Viome's Precision Nutrition Program (VPNP)

ACTIVE COMPARATOR

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

Viome's condition-based supplements

ACTIVE COMPARATOR

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.

Dietary Supplement: VIOME-designed condition-based supplements

Interventions

VIOME Precision Nutrition Program COMBINATION_PRODUCT

Precision supplement based on the participants microbiome sample results. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.

Also known as: VPNP

Viome's Precision Nutrition Program (VPNP)

VIOME-designed condition-based supplements DIETARY_SUPPLEMENT

Pre-formulated supplements based on overall health conditions. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.

Also known as: VCS

Viome's condition-based supplements

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Viome: lead

Study Sites (1)

Viome Life Sciences

Bothell, Washington, 98011, United States

Location

MeSH Terms

Conditions

Psychological Well-Being; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Behavioral Symptoms; Mental Disorders

Study Officials

• Momchilo Vuyisich

  Viome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Once enrolled, participants are randomized into one of the three arms. The coded supplements with blinded labels are shipped to the participants. The participants are not aware of which group they are randomized into.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, blinded, cohort study divided into three arms: 1) control group (placebo), 2) condition-based supplement, 3) precision-supplement

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 3, 2022
• Study Start: October 19, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 29, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)