Precision Nutrition for Mental Health

Overseen By Momchilo Vuyisich, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Viome

Must not be taking: Antibiotics, Investigational drugs

Disqualifiers: Pregnancy, IBD, Major psychiatric, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Momchilo Vuyisich

Principal Investigator

Viome

Eligibility Criteria

This trial is for US residents with obesity who are experiencing mental health conditions like anxiety or depression. Participants must understand and sign a consent form, complete an initial survey, and be willing to follow the study procedures without visiting clinical sites.

Inclusion Criteria

PHQ9 score of 5-24 (inclusive)

Willing and able to follow the trial instructions, as described in the recruitment letter

I haven't had unexplained weight loss, fevers, anemia, or blood in my stool.

Exclusion Criteria

Pregnancy (current or planned in the next 4 months)

Significant diet or lifestyle change in the previous 1 month

I have been diagnosed with inflammatory bowel disease (IBD).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into either the placebo arm or the Viome Precision Nutrition Program arm, receiving supplements and/or dietary recommendations

16 weeks

Follow-up

Participants are monitored for changes in quality of life, GAD-7, perceived stress, and PHQ-9 scores after treatment

4 weeks

Treatment Details

Interventions

• VIOME Precision Nutrition Program

Trial Overview The study is testing the VIOME Precision Nutrition Program against a control arm to see if personalized nutrition can improve mental health outcomes. Participants will be randomly assigned to one of these two groups after enrolling in the study.

Participant Groups

Group I: Viome's Precision Nutrition Program (VPNP) Experimental Treatment 1 Intervention

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 II: Placebo Placebo Group 1 Intervention

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.

VIOME Precision Nutrition Program is already approved in United States for the following indications:

Approved in United States as Viome Precision Nutrition Program for:

• Mental health disorders
• Depression
• Anxiety

Who Is Running the Clinical Trial?

Viome

Lead Sponsor

Trials

22

Recruited

37,600+