Precision Nutrition Program for Diabetes

Recruiting in Palo Alto (17 mi)

Overseen by Momchilo Vuyisich

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Viome

Must not be taking: Sulfonylureas, Exogenous insulin

Disqualifiers: Antibiotic use, Gestation, Specific diet, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests if tailored nutrition and supplements can help people with moderately high blood sugar. Participants will follow specific diet plans and take special supplements for a few months. The goal is to see if these treatments can improve their blood sugar control.

Will I have to stop taking my current medications?

If you are currently using medications that increase insulin or taking exogenous insulin, you will need to stop these to participate in the trial. The protocol does not specify other medication restrictions.

What data supports the effectiveness of the Viome's Precision Nutrition Program (VPNP) treatment for diabetes?

Research suggests that precision nutrition, which considers individual genetics, lifestyle, and metabolic status, can help manage chronic diseases like diabetes by providing personalized dietary recommendations. Although direct evidence for VPNP in diabetes is limited, similar approaches have shown promise in improving health outcomes by tailoring nutrition to individual needs.

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Is the Precision Nutrition Program for Diabetes safe for humans?

The available research on precision nutrition, which includes personalized dietary advice based on individual characteristics like genetics and lifestyle, suggests it aims to provide safe interventions for disease management. However, specific safety data for the Precision Nutrition Program for Diabetes is not detailed in the available studies.

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How is the Viome's Precision Nutrition Program treatment different from other diabetes treatments?

Viome's Precision Nutrition Program is unique because it uses a personalized approach, tailoring dietary recommendations based on an individual's genetic makeup, metabolic profile, and gut microbiome. This precision nutrition strategy aims to optimize dietary response and health, potentially offering a more effective alternative to conventional diabetes treatments that do not account for individual variability.

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Eligibility Criteria

This trial is for individuals with diabetes interested in seeing if a personalized nutrition program can help lower their HbA1c levels, which is an indicator of blood sugar control. Details on specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

Signed and dated informed consent form and medical release prior to any trial-specific procedures are performed

Able to speak and read English

Willing and able to visit a Quest Diagnostic Patient Service Center (PSC)

Exclusion Criteria

I have a major surgery or medical procedure coming up.

I will not change my diet or lifestyle during the trial, except for Viome recommendations.

Antibiotic use within one month of the GI test

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dietary recommendations and either personalized supplements or placebo supplements for 90 days

12 weeks

Online questionnaires, at-home sample collections

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The study tests Viome's Precision Nutrition Program (VPNP) to see if it effectively reduces HbA1c levels in diabetic patients. It's a randomized trial where participants will be chosen by chance to receive either the VPNP or a placebo.

Group I: Viome's Precision Nutrition Program (VPNP) Experimental Treatment 1 Intervention

Participants with HbA1c levels between 6.5-8.9% (inclusive) 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 with HbA1c levels between 6.5-8.9% (inclusive) are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Placebo capsules will contain inert and inactive materials. Participants may need to use a mobile app in order to participate in the trial.

Viome's Precision Nutrition Program (VPNP) is already approved in United States for the following indications:

🇺🇸 Approved in United States as Viome Precision Nutrition Program for:

• Metabolic wellness
• Reducing HbA1c

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Viome Life Sciences Bothell, WA

Who Is Running the Clinical Trial?

Viome Lead Sponsor

References

1. 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] 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.

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

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.

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

American Diabetes Association position statement: evidence-based nutrition principles and recommendations for the treatment and prevention of diabetes and related complications. [2022] Medical nutrition therapy for people with diabetes should be individualized, with consideration given to the individual's usual food and eating habits, metabolic profile, treatment goals and desired outcomes. Monitoring of metabolic parameters, including glucose, HbA1c, lipids, blood pressure, body weight, and renal function, when appropriate, as well as quality of life is essential to assess the need for changes in therapy and ensure successful outcomes. Ongoing nutrition self-management education and care needs to be available for individuals with diabetes. Additionally many areas of nutrition and diabetes require additional research.

4. China pubmed.ncbi.nlm.nih.gov

[Precision nutrition in the era of precision medicine]. [2018] Precision medicine has been increasingly incorporated into clinical practice and is enabling a new era for disease prevention and treatment. As an important constituent of precision medicine, precision nutrition has also been drawing more attention during physical examinations. The main aim of precision nutrition is to provide safe and efficient intervention methods for disease treatment and management, through fully considering the genetics, lifestyle (dietary, exercise and lifestyle choices), metabolic status, gut microbiota and physiological status (nutrient level and disease status) of individuals. Three major components should be considered in precision nutrition, including individual criteria for sufficient nutritional status, biomarker monitoring or techniques for nutrient detection and the applicable therapeutic or intervention methods. It was suggested that, in clinical practice, many inherited and chronic metabolic diseases might be prevented or managed through precision nutritional intervention. For generally healthy populations, because lifestyles, dietary factors, genetic factors and environmental exposures vary among individuals, precision nutrition is warranted to improve their physical activity and reduce disease risks. In summary, research and practice is leading toward precision nutrition becoming an integral constituent of clinical nutrition and disease prevention in the era of precision medicine.

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

Toward the Definition of Personalized Nutrition: A Proposal by The American Nutrition Association. [2021] Personalized nutrition holds tremendous potential to improve human health. Despite exponential growth, the field has yet to be clearly delineated and a consensus definition of the term "personalized nutrition" (PN) has not been developed. Defining and delineating the field will foster standardization and scalability in research, data, training, products, services, and clinical practice; and assist in driving favorable policy. Building on the seminal work of pioneering thought leaders across disciplines, we propose that personalized nutrition be defined as: a field that leverages human individuality to drive nutrition strategies that prevent, manage, and treat disease and optimize health, and be delineated by three synergistic elements: PN science and data, PN professional education and training, and PN guidance and therapeutics. Herein we describe the application of PN in these areas and discuss challenges and solutions that the field faces as it evolves. This and future work will contribute to the continued refinement and growth of the field of PN.Teaching pointsPN approaches can be most effective when there is consensus regarding its definition and applications.PN can be delineated into three main areas of application: PN science and data, PN education and training, PN guidance and therapeutics.PN science and data foster understanding about the impact of genetic, phenotypic, biochemical and nutritional inputs on an individual's health.PN education and training equip a variety of healthcare professionals to apply PN strategies in many healthcare settings.PN professionals have greater ability to tailor interventions via PN guidance and therapeutics.Favorable policy allows PN to be more fully integrated into the healthcare system.

6. Germany pubmed.ncbi.nlm.nih.gov

Genetics and Epigenetics in Personalized Nutrition: Evidence, Expectations, and Experiences. [2022] With the presentation of the blueprint of the first human genome in 2001 and the advent of technologies for high-throughput genetic analysis, personalized nutrition (PN) becomes a new scientific field and the first commercial offerings of genotype-based nutrition advice emerge at the same time. Here, the state of evidence for the effect of genetic and epigenetic factors in the development of obesity, the metabolic syndrome, and resulting illnesses such as non-insulin-dependent diabetes mellitus and cardiovascular diseases is summarized. This study also critically value the concepts of PN that are built around the new genetic avenue from both the academic and a commercial perspective and their effectiveness in causing sustained changes in diet, lifestyle, and for improving health. Despite almost 20 years of research and commercial direct-to-consumer offerings, evidence for the success of gene-based dietary recommendations is still generally lacking. This calls for new concepts of future PN solutions that incorporate more phenotypic measures and provide a panel of instruments (e.g., self- and bio-monitoring tools, feedback systems, algorithms based on artificial intelligence) that increases compliance based on the individual´s physical and social environment and value system.

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

Willingness to pay for personalised nutrition across Europe. [2018] Personalised nutrition (PN) may promote public health. PN involves dietary advice based on individual characteristics of end users and can for example be based on lifestyle, blood and/or DNA profiling. Currently, PN is not refunded by most health insurance or health care plans. Improved public health is contingent on individual consumers being willing to pay for the service.

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

Precision Nutrition to Improve Risk Factors of Obesity and Type 2 Diabetes. [2023] Existing dietary and lifestyle interventions and recommendations, to improve the risk factors of obesity and type 2 diabetes with the target to mitigate this double global epidemic, have produced inconsistent results due to interpersonal variabilities in response to these conventional approaches, and inaccuracies in dietary assessment methods. Precision nutrition, an emerging strategy, tailors an individual's key characteristics such as diet, phenotype, genotype, metabolic biomarkers, and gut microbiome for personalized dietary recommendations to optimize dietary response and health. Precision nutrition is suggested to be an alternative and potentially more effective strategy to improve dietary intake and prevention of obesity and chronic diseases. The purpose of this narrative review is to synthesize the current research and examine the state of the science regarding the effect of precision nutrition in improving the risk factors of obesity and type 2 diabetes.