Viome Nutritional Programs for Mental Health Conditions

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how personalized nutrition programs might improve mental health conditions. Participants will join one of three groups: one with specific supplements, one with the VIOME Precision Nutrition Program, and one with placebo pills (inactive substances). Ideal participants are U.S. residents who have experienced mild to moderate mental health issues and can use a mobile app. The trial examines whether tailored nutrition can positively impact mental well-being. 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 whether you need to stop taking your current medications. However, if you are using investigational drugs, you must stop at least 1 month before and for 4 months after the trial starts.

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

Research has shown that Viome's precision nutrition programs, which include supplements and dietary advice, are under study for their potential to improve mental health. Although direct safety information remains limited, the programs have passed initial safety checks to qualify for trials.

Similar studies on Viome's supplements have examined mental health and other issues like gut health. The research aims to create personalized nutrition plans using advanced technology, such as artificial intelligence, to enhance overall well-being.

Since these programs remain experimental and unapproved for mental health, it is important to recognize their status. Treatments in these trials have typically passed early safety tests, but detailed safety information is often limited at this stage. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Viome Precision Nutrition Program for mental health conditions because it offers a personalized approach to nutrition and supplementation, which is quite different from standard treatments like medications or psychotherapy. Unlike traditional treatments that may not address individual dietary needs, this program uses AI and advanced testing to tailor nutritional recommendations and supplements to each person's unique biology. This personalized approach could potentially improve mental health outcomes by targeting specific nutritional deficiencies or imbalances, which is a novel angle compared to conventional methods.

What evidence suggests that this trial's treatments could be effective for mental health conditions?

Research has shown that Viome's precision supplements, which participants in this trial may receive, can help reduce symptoms of depression. In one study, people taking these supplements saw their depression scores drop by more than 4 points on the PHQ-9 scale, which measures depression severity. This indicates a noticeable improvement in mental health. Another treatment arm in this trial involves the Viome Precision Nutrition Program, which uses scientific data to create personalized dietary recommendations based on how each person's body reacts to different foods. This tailored approach aims to improve mental health by meeting individual nutritional needs. Overall, early findings suggest these programs could be helpful for mental health conditions. ^{1 2 3 6 7}

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 aged 25-75 with mild to moderate depression or anxiety, who can read and speak English. They must be willing to follow the diet plan, not have used Viome products before, and not be on any specific diets like KETO or FODMAP. Pregnant women, those breastfeeding, postpartum under 90 days, or planning pregnancy are excluded.

Inclusion Criteria

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

Able to speak and read English

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

Exclusion Criteria

< 90 days postpartum

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

Answered yes to the question, 'In the past few weeks, have you wished you were dead or had thoughts about killing yourself?'

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into one of three arms and receive either placebo, Viome's condition-based supplements, or Viome's Precision Nutrition Program for mental health improvement

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VIOME-designed condition-based supplements
• VIOME Precision Nutrition Program

Trial Overview The study tests the VIOME Precision Nutrition Program and condition-based supplements designed by VIOME on mental health outcomes. Participants complete a survey and are randomly assigned into one of three groups without visiting clinical sites; everything is managed directly with participants.

How Is the Trial Designed?

Group I: Viome's condition-based supplements Active Control 1 Intervention

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.

Group II: Placebo Active Control 1 Intervention

Participants who have mental health issues are randomized into this 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.

Group III: Viome's Precision Nutrition Program (VPNP) Active Control 1 Intervention

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.

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+

Published Research Related to This Trial

Nutrigenetics aims to personalize dietary recommendations based on individual genotypes, but current research shows conflicting results, particularly regarding the impact of specific gene variants on health outcomes.

To effectively use nutrigenetics in public health, there is a need for advanced mathematical and bioinformatic approaches to analyze the combined effects of multiple gene variants and dietary interactions, rather than focusing on single genes and isolated dietary components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrigenetics and personalised nutrition: how far have we progressed and are we likely to get there? Rimbach, G., Minihane, AM.[2016]

Precision nutrition research highlights that individual responses to diets can vary significantly due to interactions between dietary factors and personal genetic makeups, which has implications for health outcomes like obesity and weight loss.

Emerging studies suggest that a comprehensive multiomics approach, including factors like the gut microbiome and biological rhythms, could enhance the prediction of how individuals respond to different diets, paving the way for personalized dietary recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition for precision health: The time is now. Qi, L.[2022]

This study will investigate whether personalized nutrition and lifestyle recommendations based on individual genotypes can lead to greater weight loss and reductions in BMI, waist circumference, and body fat percentage among 62 overweight and obese adults over a 12-month period.

The trial will be the first to implement a gene-based intervention with intensive counseling followed by a free-living simulation, aiming to provide evidence for the effectiveness of precision nutrition in weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study protocol for a pilot randomized controlled trial to evaluate the effectiveness of a gene-based nutrition and lifestyle recommendation for weight management among adults: the MyGeneMyDiet&#174; study. Nacis, JS., Labrador, JPH., Ronquillo, DGD., et al.[2023]

A 10-week personalized systems nutrition (PSN) program involving 82 healthy participants led to significant reductions in calorie intake and various unhealthy dietary components, resulting in decreased body weight, BMI, and body fat.

The program was particularly effective for individuals with lower phenotypic flexibility, showing notable reductions in LDL and total cholesterol levels, suggesting that personalized nutrition can effectively target behavior change in health-compromised groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Personalized Systems Nutrition Program Improves Dietary Patterns, Lifestyle Behaviors and Health-Related Outcomes: Results from the Habit Study. de Hoogh, IM., Winters, BL., Nieman, KM., et al.[2021]

Diet plays a crucial role in reducing the risk of non-communicable diseases, but individual responses to diets can vary significantly, limiting their effectiveness.

The review emphasizes the importance of precision nutrition and n-of-1 studies, which tailor dietary recommendations to individual responses, to maximize the health benefits of dietary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalised Interventions-A Precision Approach for the Next Generation of Dietary Intervention Studies. de Roos, B., Brennan, L.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05563857

Viome Nutritional Programs to Improve Clinical Outcomes ... Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Mental Health Conditions.

2. 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 ...

3. viomelifesciences.com viomelifesciences.com/studies

Clinical Research Studies | Viome 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 ...

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

Precision Nutrition for Mental Health Trial Overview The VIOME Precision Nutrition Program is being tested to see if it can improve outcomes for people with mental health disorders. Participants are ...

5. 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 ...

6. 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12193492/

Artificial Intelligence Applications to Personalized Dietary ... This systematic review evaluates the effectiveness of artificial intelligence (AI)-generated dietary interventions in improving clinical outcomes among adults.