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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how personalized nutrition can improve mental health in people with obesity. Participants will receive either tailored nutrition advice and supplements through the VIOME Precision Nutrition Program or a placebo (a harmless pill with no active ingredients) while using a mobile app to track their progress. It suits U.S. residents who are 50 or older or have a BMI (Body Mass Index) of 25 or more and are experiencing mild to moderate mental health issues. Participants must follow trial instructions and have no recent history of major health changes or certain conditions.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in personalized nutrition and mental health.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you have used antibiotics in the past 4 weeks or investigational drugs in the past month.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Viome Precision Nutrition Program aims to improve health by creating personalized diet and supplement plans based on individual needs. The program uses scientific data to make these tailored recommendations. Although specific safety data for this program alone is not available, it seeks to promote health by addressing personal nutritional needs.

Researchers are studying the program for any side effects and how well participants can handle it. The trial's "Not Applicable" phase designation indicates that the treatment is still in early testing stages, so detailed safety information might not yet be available. However, programs like this generally aim to improve health with minimal risk, as they involve nutrition and supplements rather than new drugs. Prospective participants should know that the approach relies on widely accepted nutritional science, which usually has a good safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Viome Precision Nutrition Program because it offers a personalized approach to mental health, which is different from traditional medications like antidepressants and therapy. This program tailors nutritional recommendations and supplements to each individual's needs, potentially addressing the root causes of mental health issues rather than just managing symptoms. By utilizing a mobile app for convenience and real-time adjustments, it empowers participants to actively manage their mental health through diet and lifestyle changes. This innovative method could provide a more holistic and sustainable way to support mental well-being.

What evidence suggests that the Viome Precision Nutrition Program could be effective for mental health?

Research has shown that the VIOME Precision Nutrition Program, which participants in this trial may receive, can help improve mental health symptoms. Studies have found that personalized nutrition, which provides dietary advice and supplements based on each person's gut health, can lead to better mental health. This method has helped with conditions like depression and anxiety. Early results suggest that tailored nutrition can significantly enhance mental well-being. The program uses AI and gut health information to design a diet plan tailored to each person’s needs, aiming to boost overall well-being. ^{1 2 4 5 6}

Who Is on the Research Team?

Momchilo Vuyisich

Principal Investigator

Viome

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. trialx.com trialx.com/clinical-trials/listings/219985/viome-precision-nutritional-programs-to-improve-clinical-outcomes-for-mental-health-conditions/

Viome Precision Nutritional Programs to Improve Clinical ... Placebo and Viome's Precision Nutrition Program include supplements and/or dietary recommendations towards improving the symptoms associated ...

2. viomelifesciences.com viomelifesciences.com/studies

Studies | VNext VLS The primary objective of this clinical trial is to test if supplements and/or nutritional recommendations can help improve the signs and symptoms of mental ...

3. biorxiv.org biorxiv.org/content/10.1101/2021.04.24.441290v3.full.pdf

Data-driven precision nutrition improves clinical outcomes ... Data-driven precision nutrition, using AI and gut microbiome data, improves clinical outcomes for IBS, depression, anxiety, and T2D.

4. withpower.com withpower.com/trial/phase-mental-health-issue-6-2024-2ab02

Precision Nutrition for Mental Health Yes, the VIOME Precision Nutrition Program is promising because it uses personalized nutrition to improve health outcomes. By considering individual ...

5. try.viome.com try.viome.com/studyv2113-1

Mental Health And Nutrition The primary objective of this clinical trial is to test if supplements and/or nutritional recommendations can help improve the signs and symptoms of mental ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11994916/

A Scoping Review of Artificial Intelligence for Precision Nutrition These plans are developed using scientific data on how individual bodies respond to different foods, aiming to optimize health outcomes by addressing unique ...