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

NCT06502717 | Recruiting

• 1 other identifier: V211.3_v2
• 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 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.

Conditions

Mental Health Issue; Depression; Anxiety

Keywords

mental health; diet; supplements; vitamins; stress

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Placebo

NO 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.

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

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)

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

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Study Officials

• Momchilo Vuyisich

  Viome

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mory Mehrtash

CONTACT

(425) 300-6933; studies@viome.com

Momchilo Vuyisich

CONTACT

(425) 300-6933; studies@viome.com

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 two 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 two study arms: 1) control group (placebo), 2) precision-supplement

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 16, 2024
• Study Start: July 8, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 29, 2025

Record last verified: 2024-06

Locations

US (1)