Precision Nutrition for Mental Health
Recruiting in Palo Alto (17 mi)
Overseen byMomchilo Vuyisich
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Viome
Must not be taking: Antibiotics, Investigational drugs
Disqualifiers: Pregnancy, IBD, Major psychiatric, others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345What 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.
12678Is 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.
12479Eligibility 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.
+4 more
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.
+15 more
Trial 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
Participant Groups
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.
2Treatment groups
Active Control
Group I: PlaceboActive Control1 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 Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Viome Life SciencesBothell, WA
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Who Is Running the Clinical Trial?
ViomeLead Sponsor
References
Nutrition for precision health: The time is now. [2022]Precision nutrition has emerged as a boiling area of nutrition research, with a particular focus on revealing the individual variability in response to diets that is determined mainly by the complex interactions of dietary factors with the multi-tiered "omics" makeups. Reproducible findings from the observational studies and diet intervention trials have lent preliminary but consistent evidence to support the fundamental role of gene-diet interactions in determining the individual variability in health outcomes including obesity and weight loss. Recent investigations suggest that the abundance and diversity of the gut microbiome may also modify the dietary effects; however, considerable instability in the results from the microbiome research has been noted. In addition, growing studies suggest that a complicated multiomics algorithm would be developed by incorporating the genome, epigenome, metabolome, proteome, and microbiome in predicting the individual variability in response to diets. Moreover, precision nutrition would also scrutinize the role of biological (circadian) rhythm in determining the individual variability of dietary effects. The evidence gathered from precision nutrition research will be the basis for constructing precision health dietary recommendations, which hold great promise to help individuals and their health care providers create precise and effective diet plans for precision health in the future.
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]Managing nutrition and lifestyle practices, nutrition phenotypes, and the genome forms the foundation of precision nutrition. Precision nutrition focuses on metabolic variability among individuals, and one approach to achieving its goals is to integrate gene-based nutrition and lifestyle recommendations in nutrition practice. However, scientific evidence proving the effectiveness of such recommendations is limited. This study will examine whether providing nutrition and lifestyle recommendations based on individual genotype can lead to better weight loss, along with reduction in body mass index (BMI), waist circumference, and body fat percentage among overweight and obese adults.
Does Personalized Nutrition Advice Improve Dietary Intake in Healthy Adults? A Systematic Review of Randomized Controlled Trials. [2023]Personalized nutrition (PN) behavior-change interventions are being used increasingly in attempts to improve dietary intake; however, the impact of PN advice on improvements in dietary intake has not been reviewed systematically. The aim of this systematic review was to evaluate the effect of PN advice on changes in dietary intake compared with generalized advice in healthy adults. Three databases (EMBASE, PubMed, and CINAHL) were searched between 2009 and 2020 for randomized controlled trials (RCTs) that tested the effect of PN and tailored advice based on diet, phenotype, or genetic information. The Evidence Analysis Library Quality Criteria checklist was used to conduct a risk-of-bias assessment. Information on intervention design and changes in nutrients, foods, and dietary patterns was extracted from the 11 studies meeting the inclusion criteria. Studies were conducted in the United States, Canada, or Europe; reported outcomes on 57 to 1488 participants; and varied in follow-up duration from 1 to 12 mo. Five studies incorporated behavior-change techniques. The risk of bias for included studies was low. Overall, the available evidence suggests that dietary intake is improved to a greater extent in participants randomly assigned to receive PN advice compared with generalized dietary advice. Additional well-designed PN RCTs are needed that incorporate behavior-change techniques, a broader range of dietary outcomes, and comparisons between personalization based on dietary, biological, and/or lifestyle information.
Precision (Personalized) Nutrition: Understanding Metabolic Heterogeneity. [2021]People differ in their requirements for and responses to nutrients and bioactive molecules in the diet. Many inputs contribute to metabolic heterogeneity (including variations in genetics, epigenetics, microbiome, lifestyle, diet intake, and environmental exposure). Precision nutrition is not about developing unique prescriptions for individual people but rather about stratifying people into different subgroups of the population on the basis of biomarkers of the above-listed sources of metabolic variation and then using this stratification to better estimate the different subgroups' dietary requirements, thereby enabling better dietary recommendations and interventions. The hope is that we will be able to subcategorize people into ever-smaller groups that can be targeted in terms of recommendations, but we will never achieve this at the individual level, thus, the choice of precision nutrition rather than personalized nutrition to designate this new field. This review focuses mainly on genetically related sources of metabolic heterogeneity and identifies challenges that need to be overcome to achieve a full understanding of the complex interactions between the many sources of metabolic heterogeneity that make people differ from one another in their requirements for and responses to foods. It also discusses the commercial applications of precision nutrition.
Nutritional Psychiatry: How Diet Affects Brain through Gut Microbiota. [2021]Nutritional sciences have been recognized as being of paramount importance for the prevention of non-communicable diseases. Among others, mental health disorders have been hypothesized to be influenced by dietary risk through a variety of molecular mechanisms. The improvements in the technology and implementation of-omics sciences in terms of nutrition have created the possibility of studying the relation between diet, gut microbiota and mental health. The gut-brain-axis represents the core rationale setting the stage for a relatively new discipline of study defined as "nutritional psychiatry". Research on this matter will help to better understand the relation between food and mood, sleep quality, cognition, and mental health in general.
Potential of nutrigenetics in the treatment of metabolic disorders. [2019]Nutrigenetics is a genotype-based medical concept used in pursuit of individualized or personalized nutrition programs. That is, nutrigenetics is the study of what the effect of an individual's genetic make-up is on their response to diet or specific nutrients. Furthermore, the concept is that if an individual is genotyped at various genes for disease-associated risk alleles, a genotype-based diet or nutritional supplement regimen may be useful to overcome the genetic variation and reduce risk or prevent the disease altogether. The metabolic diseases considered in this article include obesity-related diseases and cardiovascular disease. The thesis of this article is that nutrigenetics, although an intuitively attractive approach to individualized nutrition, is not yet fully developed for evidence-based medical practice and is inappropriate as direct-to-the-consumer genetic testing. Although the genetic variations associated with disease risk can be determined, presently, relevant loci are too few in number, have modest effects at most, add little to the overall disease-risk prediction and any nutritional therapy based on genotype must be tested in case-control clinical trials.
A Novel Personalized Systems Nutrition Program Improves Dietary Patterns, Lifestyle Behaviors and Health-Related Outcomes: Results from the Habit Study. [2021]Personalized nutrition may be more effective in changing lifestyle behaviors compared to population-based guidelines. This single-arm exploratory study evaluated the impact of a 10-week personalized systems nutrition (PSN) program on lifestyle behavior and health outcomes. Healthy men and women (n = 82) completed the trial. Individuals were grouped into seven diet types, for which phenotypic, genotypic and behavioral data were used to generate personalized recommendations. Behavior change guidance was also provided. The intervention reduced the intake of calories (-256.2 kcal; p < 0.0001), carbohydrates (-22.1 g; p < 0.0039), sugar (-13.0 g; p < 0.0001), total fat (-17.3 g; p < 0.0001), saturated fat (-5.9 g; p = 0.0003) and PUFA (-2.5 g; p = 0.0065). Additionally, BMI (-0.6 kg/m2; p < 0.0001), body fat (-1.2%; p = 0.0192) and hip circumference (-5.8 cm; p < 0.0001) were decreased after the intervention. In the subgroup with the lowest phenotypic flexibility, a measure of the body's ability to adapt to environmental stressors, LDL (-0.44 mmol/L; p = 0.002) and total cholesterol (-0.49 mmol/L; p < 0.0001) were reduced after the intervention. This study shows that a PSN program in a workforce improves lifestyle habits and reduces body weight, BMI and other health-related outcomes. Health improvement was most pronounced in the compromised phenotypic flexibility subgroup, which indicates that a PSN program may be effective in targeting behavior change in health-compromised target groups.
Nutrigenetics and personalised nutrition: how far have we progressed and are we likely to get there? [2016]Nutrigenetics and personalised nutrition are components of the concept that in the future genotyping will be used as a means of defining dietary recommendations to suit the individual. Over the last two decades there has been an explosion of research in this area, with often conflicting findings reported in the literature. Reviews of the literature in the area of apoE genotype and cardiovascular health, apoA5 genotype and postprandial lipaemia and perilipin and adiposity are used to demonstrate the complexities of genotype-phenotype associations and the aetiology of apparent between-study inconsistencies in the significance and size of effects. Furthermore, genetic research currently often takes a very reductionist approach, examining the interactions between individual genotypes and individual disease biomarkers and how they are modified by isolated dietary components or foods. Each individual possesses potentially hundreds of 'at-risk' gene variants and consumes a highly-complex diet. In order for nutrigenetics to become a useful public health tool, there is a great need to use mathematical and bioinformatic tools to develop strategies to examine the combined impact of multiple gene variants on a range of health outcomes and establish how these associations can be modified using combined dietary strategies.
Addressing the Nutritional Phenotype Through Personalized Nutrition for Chronic Disease Prevention and Management. [2019]The primary focus of public health recommendations related to the prevention of food-related chronic disease has been on the adoption of healthy dietary patterns; however, implementation has been challenging. There has been increasing recognition that an individual's diet and environment may impact disease susceptibility by affecting the expression of genes involved in critical metabolic pathways. Precision nutrition (PN) has emerged to translate discoveries about diversity in nutrient metabolism between subgroups and the inter-individual variability in the responses to dietary interventions. The overarching goals of PN are to deliver individualized, actionable dietary therapy based on an individual's nutritional phenotype, created from the integration of genetics, metabolic profile, and environmental factors in order to prevent and treat chronic disease. This review addresses the developments of genome- and omic-driven PN and how they have been used to prevent and treat disease, as well as how they might be integrated into broader clinical practice.