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Viome Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions

Primary Purpose

Mental Health, Depression, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VIOME Precision Nutrition Program
VIOME-designed condition-based supplements
Sponsored by
Viome
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mental Health focused on measuring mental health, diet, supplements, vitamins, stress

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

  • Answer of 1, 2, or 3 on question 9 of PHQ9
  • Unwilling to change their current diet
  • Prior use of Viome products or services
  • Antibiotic use in the previous 3 months
  • 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 3 months or next 4 months, unless it is a part of the trial
  • Prebiotic or probiotic supplement use in the previous 30 days
  • Regular use (> 3 days a week) of any products specifically marketed for gut health, such as DanActive, Activia, Yakult, multi grain/prebiotic cereals/bars, etc.
  • Regular use (> 3 days a week) of fermented foods, such as Kefir, Miso, Natto, Tempeh, Kimchi, Sourdough, Sauerkraut, Kombucha, etc.
  • IBD diagnosis -Major psychiatric/DSM-5 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
  • Chronic pain syndrome other than IBS in past year
  • Start of a new prescription medication within the past 3 months or the next 4 months
  • Allergies to any supplement ingredients listed in the screening survey
  • Currently on a specific diet: FODMAP, KETO, PALEO

  • 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

Sites / Locations

  • Viome Life SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Placebo

Viome's Precision Nutrition Program (VPNP)

Viome's condition-based supplements

Arm Description

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 and inactive materials. Participants may need to use a mobile app in order to participate in the trial.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 28, 2022
Last Updated
March 24, 2023
Sponsor
Viome
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1. Study Identification

Unique Protocol Identification Number
NCT05563857
Brief Title
Viome Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions
Official Title
Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Mental Health Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Viome

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 wellness. The trial will last approximately 4 months for each participant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health, Depression, Anxiety
Keywords
mental health, diet, supplements, vitamins, stress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, blinded, cohort study divided into three arms: 1) control group (placebo), 2) condition-based supplement, 3) precision-supplement
Masking
Participant
Masking Description
Once enrolled, participants are randomized into one of the three arms. The coded supplements with blinded labels are shipped to the participants. The participants are not aware of which group they are randomized into.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
No Intervention
Arm Description
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 and inactive materials. Participants may need to use a mobile app in order to participate in the trial.
Arm Title
Viome's Precision Nutrition Program (VPNP)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Viome's condition-based supplements
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
VIOME Precision Nutrition Program
Other Intervention Name(s)
VPNP
Intervention Description
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
Dietary Supplement
Intervention Name(s)
VIOME-designed condition-based supplements
Other Intervention Name(s)
VCS
Intervention Description
Pre-formulated supplements based on overall health conditions. Participants in this arm may have any combination of supplements, diet recommendations, and/or coaching.
Primary Outcome Measure Information:
Title
Reduced PHQ-9 Score
Description
Reduced PHQ-9 score for both VCS and VPNP groups compared to baseline scores.
Time Frame
~4 months
Title
Reduced GAD-7 Score
Description
Reduced GAD-7 score for both VCS and VPNP groups compared to baseline scores.
Time Frame
~4 months
Title
Reduced Perceived Stress Scale Score
Description
Reduced Perceived Stress Scale score for both VCS and VPNP groups compared to baseline scores.
Time Frame
~4 months
Title
Increased Quality of Life Score
Description
Increased quality of life score for both VCS and VPNP groups compared to baseline scores.
Time Frame
~4 months
Title
Correlation between microbial changes and clinical outcomes
Description
Correlation between microbial changes on VCS or VPNP with clinical outcomes.
Time Frame
~4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mory Mehrtash
Phone
(425) 300-6933
Email
studies@viome.com
First Name & Middle Initial & Last Name or Official Title & Degree
Momchilo Vuyisich
Phone
(425) 300-6933
Email
studies@viome.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Momchilo Vuyisich
Organizational Affiliation
Viome
Official's Role
Principal Investigator
Facility Information:
Facility Name
Viome Life Sciences
City
Bothell
State/Province
Washington
ZIP/Postal Code
98011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Momchilo Vuyisich
Phone
425-300-6933
Email
studies@viome.com
First Name & Middle Initial & Last Name & Degree
Mory Mehrtash
Phone
(425) 300-6933
Email
studies@viome.com
First Name & Middle Initial & Last Name & Degree
Momchilo Vuyisich

12. IPD Sharing Statement

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