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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the idea that Precision Nutrition for Mental Health is an effective treatment?

The available research shows that precision nutrition, which includes personalized dietary recommendations based on individual genetic and lifestyle factors, can lead to better health outcomes. For example, studies have found that personalized nutrition advice improves dietary intake more effectively than general advice. Additionally, the concept of nutritional psychiatry suggests that diet can influence mental health through the gut-brain connection, indicating potential benefits for mental health conditions. However, specific evidence directly linking Precision Nutrition for Mental Health to improved mental health outcomes is limited, and more research is needed to confirm its effectiveness. ^{1 2 3 4 5}

What safety data exists for the Precision Nutrition for Mental Health treatment?

The provided research does not directly address safety data for the Precision Nutrition for Mental Health treatment or its related programs like the VIOME Precision Nutrition Program. The studies focus on the potential and effectiveness of nutrigenetics and personalized nutrition, highlighting the need for further research and clinical trials to establish evidence-based practices. No specific safety data or adverse effects are mentioned in the abstracts. ^{1 2 6 7 8}

Is the VIOME Precision Nutrition Program a promising treatment for mental health?

Yes, the VIOME Precision Nutrition Program is promising because it uses personalized nutrition to improve health outcomes. By considering individual differences in genetics, metabolism, and lifestyle, it aims to create tailored diet plans that can help improve mental health and overall well-being. ^{1 2 4 7 9}

Research Team

Momchilo Vuyisich

Principal Investigator

Viome

Eligibility Criteria

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.

I am not willing to change my current diet.

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 possibly dietary recommendations for mental health improvement

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

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.

Participant Groups

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+

Findings from Research

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

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]

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]

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]

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]

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 (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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. Switzerland 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Does Personalized Nutrition Advice Improve Dietary Intake in Healthy Adults? A Systematic Review of Randomized Controlled Trials. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

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

7. Switzerland 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. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Nutrigenetics and personalised nutrition: how far have we progressed and are we likely to get there? [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Addressing the Nutritional Phenotype Through Personalized Nutrition for Chronic Disease Prevention and Management. [2019]