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

NCT06190184 | Unknown

• 1 other identifier: V211.3.1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Health Issue; Mental Health Disorder; Mental Health; Depression; Depression, Anxiety; Anxiety; Anxiety Disorders; Anxiety Depression; Anxiety State

Keywords

Mental Health; diet; supplements; vitamins; stress

Outcome Measures

Primary Outcomes (4)

• Change in PHQ-9 Score

  Change in PHQ-9 score for VPNP group compared to baseline scores.

  4 months

• Change in GAD-7 Score

  Change in GAD-7 score for VPNP group compared to baseline scores.

  4 months

• Change in Quality of Life Score

  Change in quality of life score for VPNP group compared to baseline scores.

  4 months

• Change in Perceived Stress Scale Score

  Change in perceived stress score for VPNP group compared to baseline scores.

  4 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Viome's Precision Nutrition Program (VPNP)

EXPERIMENTAL

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

Interventions

VIOME Precision Nutrition Program 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.

Also known as: VPNP

Viome's Precision Nutrition Program (VPNP)

Control arm OTHER

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.

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resident of the United States
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Viome: lead

Study Sites (1)

Viome Life Sciences

Bothell, Washington, 98011, United States

RECRUITING

MeSH Terms

Conditions

Mental Disorders; Psychological Well-Being; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Behavioral Symptoms

Study Officials

• Momchilo Vuyisich

  Viome

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mory Mehrtash

CONTACT

(425) 300-6933; studies@viome.com

Momchilo Vuyisich

CONTACT

(425) 300-6933; studies@viome.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Once enrolled, participants are randomized into one of the 2 study arms. The coded supplements with blinded labels are shipped to the participants. The participants are not aware of which group they are randomized into.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, blinded, cohort study divided into two study arms: 1) control group (placebo), 2) precision-supplement

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: January 5, 2024
• Study Start: October 26, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

US (1)