Viome Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions

NCT ID: NCT05563857

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-19
• Study Completion Date: 2025-12-31

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.

Conditions

Mental Health; Depression; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

VIOME Precision Nutrition Program

Intervention Type: 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.

Viome's 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.

Group Type: ACTIVE_COMPARATOR

VIOME-designed condition-based supplements

Intervention Type: 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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

VIOME-designed condition-based supplements

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

VPNP; VCS

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Viome

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Momchilo Vuyisich

Role: PRINCIPAL_INVESTIGATOR

Viome

Locations

Viome Life Sciences

Bothell, Washington, United States

Countries

United States

Other Identifiers

V211.3

Identifier Type: -

Identifier Source: org_study_id