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

Viome

Status: Enrolling

Conditions: Mental Health Issue; Depression; Anxiety

Treatments: Combination Product: VIOME Precision Nutrition Program

Study type: Interventional

Funder types: Industry

Identifiers

NCT06502717

V211.3_v2

Details and patient eligibility

About

US residents who have mental health issues sign the informed consent form and are screened and enrolled for this study. Participants complete a survey upon enrollment and are randomized into one of two study arms. This study is direct to participant and will NOT utilize clinical sites.

Full description

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

Placebo 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No 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

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

150 participants in 2 patient groups

Placebo

No Intervention group

Description:

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 or inactive ingredients. Participants may need to use a mobile app in order to participate in the trial.

Viome's Precision Nutrition Program (VPNP)

Active Comparator group

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.

Treatment:

Combination Product: VIOME Precision Nutrition Program