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

150 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the Viome Nutritional Programs for Mental Health Conditions treatment?

Research shows that nutrition interventions, including supplements and dietary changes, can have positive effects on mental health conditions like depression and schizophrenia. Many studies report significant improvements when using essential fatty acids, vitamins, or minerals, suggesting that personalized nutrition programs like Viome's could be beneficial. ^{1 2 3 4 5}

Is the Viome Nutritional Program safe for humans?

The Viome Nutritional Program, evaluated as a personalized systems nutrition program, has been shown to improve lifestyle habits and reduce body weight and other health-related outcomes in a study with healthy participants, suggesting it is generally safe for human use. ^{6 7 8 9 10}

How is the Viome Precision Nutrition Program different from other treatments for mental health conditions?

The Viome Precision Nutrition Program is unique because it focuses on personalized nutrition recommendations to support mental health, unlike traditional treatments that often rely on medications. This approach considers the role of diet and specific nutrients, such as Omega-3 fatty acids and vitamins, in improving mental well-being, which is a growing area of interest in psychiatric care. ^{1 2 3 11 12}

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 who are enrolled complete a survey upon enrollment and are randomized into one of three 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 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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Augmenting Clinical Interventions in Psychiatric Disorders: Systematic Review and Update on Nutrition. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Nutritional medicine as mainstream in psychiatry. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

[The influence of diet on mental health]. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Nutritional Psychiatry: Where to Next? [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

Nutrition interventions in populations with mental health conditions: a scoping review. [2021]

6. 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&#174; study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

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

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

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

9. 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]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Personalised Interventions-A Precision Approach for the Next Generation of Dietary Intervention Studies. [2018]

11. Spain pubmed.ncbi.nlm.nih.gov

Nutritional supplements in psychotic disorders. [2018]

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

Vitamin d status and cardiometabolic risk factors in long-term psychiatric inpatients. [2021]