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

January 3, 2024 updated by: Viome

Testing the Efficacy of Viome Precision Supplements to Improve Clinical Outcomes for Mental Health Conditions

US residents who have obesity and 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 two arms. This study is direct to participant and will not utilize clinical sites.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants who meet the eligibility criteria are randomized into any of the two arms including: the placebo arm or the VIOME Precision Nutrition Program (VPNP) arm.

Placebo and Viome's Precision Nutrition Program include supplements and/or dietary recommendations towards improving the symptoms associated with metabolic wellness. The trial will last approximately 4 months for each participant.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Washington
      • Bothell, Washington, United States, 98011
        • Recruiting
        • Viome Life Sciences
        • Principal Investigator:
          • Momchilo Vuyisich, PhD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Resident of the United States
  • 50 years old and older OR BMI of 25 or greater
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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 and inactive materials. Participants may need to use a mobile app in order to participate in the trial.
Other: Control arm
Participants who have mental health issues are randomized into this arm. They may be provided with any combination of nutritional recommendations and/or supplements. Placebo capsules will contain inert and inactive materials. Participants may need to use a mobile app in order to participate in the trial.
Other Names:
  • Placebo
Experimental: Viome's Precision Nutrition Program (VPNP)
Participants who have mental health issues are randomized into this study 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
Precision supplement based on the participants microbiome sample results. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.
Other Names:
  • VPNP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PHQ-9 Score
Time Frame: 4 months
Change in PHQ-9 score for VPNP group compared to baseline scores.
4 months
Change in GAD-7 Score
Time Frame: 4 months
Change in GAD-7 score for VPNP group compared to baseline scores.
4 months
Change in Quality of Life Score
Time Frame: 4 months
Change in quality of life score for VPNP group compared to baseline scores.
4 months
Change in Perceived Stress Scale Score
Time Frame: 4 months
Change in perceived stress score for VPNP group compared to baseline scores.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Viome

Investigators

  • Principal Investigator: Momchilo Vuyisich, Viome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2023

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 8, 2023

First Submitted That Met QC Criteria

January 3, 2024

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V211.3.1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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