Viome Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions

Last updated: January 27, 2025
Sponsor: Viome
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Depression

Treatment

VIOME-designed condition-based supplements

VIOME Precision Nutrition Program

Clinical Study ID

NCT05563857
V211.3
  • Ages 25-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: VIOME-designed condition-based supplements
Phase:
Study Start date:
October 19, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Viome Life Sciences

    Bothell, Washington 98011
    United States

    Site Not Available

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