Viome Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions

Not Applicable

Active, not recruiting

• Conditions: Depression; Anxiety; Mental Health
• Interventions: Combination Product: VIOME Precision Nutrition Program; Dietary Supplement: VIOME-designed condition-based supplements

• Registration Number: NCT05563857
• Lead Sponsor: Viome

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.

Detailed Description

Participants who meet the eligibility criteria are randomized into any of the three arms including: the control arm, VIOME's condition-based supplements (VCS) arm or the VIOME Precision Nutrition Program (VPNP) arm.

Placebo, Viome-designed condition-based supplements 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 Timeline

• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-09-28
• Study First Posted: 2022-10-03
• Study Start: 2022-10-19
• Status Verified: 2024-06
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Viome's Precision Nutrition Program (VPNP)	VIOME Precision Nutrition Program	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.
Viome's condition-based supplements	VIOME-designed condition-based supplements	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.

Primary Outcome Measures

Name	Time	Method
Reduced Perceived Stress Scale Score	~4 months	Reduced Perceived Stress Scale score for both VCS and VPNP groups compared to baseline scores.
Increased Quality of Life Score	~4 months	Increased quality of life score for both VCS and VPNP groups compared to baseline scores.
Reduced PHQ-9 Score	~4 months	Reduced PHQ-9 score for both VCS and VPNP groups compared to baseline scores.
Reduced GAD-7 Score	~4 months	Reduced GAD-7 score for both VCS and VPNP groups compared to baseline scores.
Correlation between microbial changes and clinical outcomes	~4 months	Correlation between microbial changes on VCS or VPNP with clinical outcomes.

Trial Locations

Locations (1)

Viome Life Sciences; 🇺🇸 Bothell, Washington, United States