Recruiting

Viome Precision Nutritional Programs

Sponsor:

Viome

Code:

NCT06502717

Conditions

Mental Health Issue

Depression

Anxiety

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

VIOME Precision Nutrition Program

Study Details

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

Study ID

NCT06502717

Start date

Jul 8, 2024

Status verified date

Jun, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

Primary outcome measure

  • Reduced PHQ-9 Score [ Time Frame: ~4 months ]
  • Reduced GAD-7 Score [ Time Frame: ~4 months ]
  • Reduced Perceived Stress Scale Score [ Time Frame: ~4 months ]
  • Increased Quality of Life Score [ Time Frame: ~4 months ]
  • Correlation between microbial changes and clinical outcomes [ Time Frame: ~4 months ]

Central Contacts and Locations

Central contacts

Mory Mehrtash

(425) 300-6933studies@viome.com

Momchilo Vuyisich

(425) 300-6933studies@viome.com

Locations

Viome Life Sciences

Recruiting

Bothell, Washington, United States, 98011

Contacts

Momchilo Vuyisich, PhD

(425) 300-6933studies@viome.com

Mory Mehrtash, MSHS

(425) 300-6933studies@viome.com

Principal Investigator:

Momchilo Vuyisich, PhD

More Information

Sponsor

Viome

Last update posted

Jan 29, 2025

Last verified

Jun, 2024

Keywords

  • mental health
  • diet
  • supplements
  • vitamins
  • stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Viome on 2025-01-29.