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

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

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on how nutrition can improve mental health. Participants divide into two groups: one receives personalized nutritional advice and supplements through the VIOME Precision Nutrition Program, while the other receives placebo capsules containing inactive ingredients. It suits U.S. residents with mild to moderate mental health challenges who have not used Viome products before. Participants must be willing to follow the trial's instructions and use a mobile app. As an unphased trial, this study offers a unique opportunity to explore the potential benefits of personalized nutrition for mental health.

Do I have to stop taking my current medications for the trial?

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 within 1 month prior to and 4 months after the trial start.

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

Research on the safety of the VIOME Precision Nutrition Program remains limited, with no specific information on side effects or safety issues from past studies. The program designs personalized nutrition plans, using dietary changes to enhance health. Since it emphasizes nutrition rather than medication, it is generally considered safe.

The trial in question is marked as "Not Applicable" for its phase, indicating that the study is either in its early stages or does not follow the typical phases of drug trials. In such cases, extensive safety data from previous trials may be lacking. However, personalized nutrition generally involves common foods or supplements, which are typically safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Viome Precision Nutrition Program (VPNP) because it approaches mental health through personalized nutrition, which is not a focus of most standard treatments like medication and therapy. Unlike traditional methods that generally target chemical imbalances or psychological factors, VPNP tailors nutritional recommendations and supplements to each individual, potentially addressing underlying metabolic or gut health issues that impact mental well-being. This personalized approach is made possible through the use of a mobile app, which helps participants track and adapt their nutrition plan, offering a novel way to support mental health that could complement existing therapies.

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

Research has shown that the VIOME Precision Nutrition Program, available to participants in this trial, can improve mental health by offering personalized diet and supplement advice. The program uses advanced technology to analyze food and supplements, aiming to support specific bodily functions. Early findings suggest that personalized nutrition might alleviate symptoms of mental health conditions. Studies indicate that this approach can enhance health by addressing each person's unique nutritional needs. Although more research is necessary, these early results are promising for those interested in managing mental health through nutrition. ^{1 3 5 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 with mental health issues like anxiety or depression. Participants must be willing to sign an informed consent form and complete a survey upon enrollment.

Inclusion Criteria

Able to speak and read English

PHQ9 score of 5-24 (inclusive)

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

Exclusion Criteria

I have used Viome products or services before.

I haven't had major surgery in the last 6 months and don't plan any in the next 4 months.

Allergies to any supplement ingredients listed in the screening survey

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 possibly dietary recommendations 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 Precision Nutrition Program

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 randomly placed into one of two groups in this direct-to-participant study without clinical sites.

How Is the Trial Designed?

Group I: Placebo Active Control 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 or inactive ingredients. Participants may need to use a mobile app in order to participate in the trial.

Group II: 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 create personalized nutrition plans based on an individual's genetic makeup, potentially helping to reduce the risk of metabolic diseases like obesity and cardiovascular disease.

However, the current state of nutrigenetics is not fully developed for practical medical use, as the genetic variations identified so far have limited predictive power and require further testing in clinical trials before being used in direct-to-consumer genetic testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential of nutrigenetics in the treatment of metabolic disorders. Wood, PA.[2019]

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]

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]

Precision nutrition aims to group individuals into subpopulations based on genetic, epigenetic, microbiome, and lifestyle factors to better tailor dietary recommendations, rather than creating unique diets for each person.

The review highlights the challenges in understanding the complex interactions of these factors that contribute to metabolic differences, which is essential for advancing the field of precision nutrition and its commercial applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision (Personalized) Nutrition: Understanding Metabolic Heterogeneity. Zeisel, SH.[2021]

Personalized nutrition (PN) interventions lead to greater improvements in dietary intake compared to generalized dietary advice, based on a systematic review of 11 randomized controlled trials involving 57 to 1488 participants across the US, Canada, and Europe.

The studies showed a low risk of bias and varied follow-up durations from 1 to 12 months, indicating that tailored dietary advice can be more effective, but further research is needed to explore different personalization methods and incorporate behavior-change techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Personalized Nutrition Advice Improve Dietary Intake in Healthy Adults? A Systematic Review of Randomized Controlled Trials. Jinnette, R., Narita, A., Manning, B., et al.[2023]

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]

Nutritional sciences play a crucial role in preventing non-communicable diseases, including mental health disorders, by influencing dietary risks through various molecular mechanisms.

The emerging field of 'nutritional psychiatry' explores the connection between diet, gut microbiota, and mental health, highlighting the importance of the gut-brain-axis in understanding how food affects mood, sleep quality, and cognition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Psychiatry: How Diet Affects Brain through Gut Microbiota. Grosso, G.[2021]

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® study. Nacis, JS., Labrador, JPH., Ronquillo, DGD., et al.[2023]

Precision nutrition (PN) aims to provide personalized dietary recommendations based on an individual's genetics, metabolic profile, and environment, which can help prevent and treat chronic diseases more effectively.

This approach recognizes that traditional dietary guidelines may not be sufficient for everyone, as individual responses to diet can vary significantly, highlighting the need for tailored nutritional strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing the Nutritional Phenotype Through Personalized Nutrition for Chronic Disease Prevention and Management. Laddu, D., Hauser, M.[2019]

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