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

NCT ID: NCT06190184

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-26
• Study Completion Date: 2024-12-31

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Control arm

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

VIOME Precision Nutrition Program

Intervention Type: 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.

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.

Intervention Type: COMBINATION_PRODUCT

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.

Intervention Type: OTHER

Other Intervention Names

VPNP; Placebo

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Viome

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Momchilo Vuyisich

Role: PRINCIPAL_INVESTIGATOR

Viome

Locations

Viome Life Sciences

Bothell, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mory Mehrtash

Role: CONTACT

studies@viome.com

(425) 300-6933

Momchilo Vuyisich

Role: CONTACT

studies@viome.com

(425) 300-6933

Facility Contacts

Momchilo Vuyisich, PhD

Role: primary

studies@viome.com

425-300-6933

Mory Mehrtash, MSHS

Role: backup

studies@viome.com

(425) 300-6933

Other Identifiers

V211.3.1

Identifier Type: -

Identifier Source: org_study_id