Viome Nutritional Programs for Metabolic Health

Overseen By Momchilo Vuyisich, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Viome

Must not be taking: Sulfonylureas, Exogenous insulin, others

Disqualifiers: Pregnancy, IBD, Cancer therapy, 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 obesity and 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.

Will I have to stop taking my current medications?

The trial requires that you stop using medications that increase insulin or exogenous insulin. Also, if you're prescribed any drugs that may interact with the study's supplements, you may need to stop those as well.

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

Research suggests that personalized nutrition programs can improve dietary habits and health outcomes, such as reducing calorie intake, body weight, and cholesterol levels. These programs use individual data to tailor recommendations, which may be more effective than general guidelines, especially for those with specific health challenges. ^{1 2 3 4 5}

Is the Viome Nutritional Program safe for humans?

The Habit Study suggests that personalized nutrition programs like Viome's are generally safe, as they improved dietary habits and health outcomes without reported adverse effects in healthy participants. ^{1 3 5 6 7}

How does the Viome Precision Nutrition Program treatment differ from other treatments for metabolic health?

The Viome Precision Nutrition Program is unique because it offers personalized nutrition recommendations based on an individual's genetic, phenotypic, and behavioral data, unlike standard treatments that use a one-size-fits-all approach. This program aims to improve dietary patterns and lifestyle behaviors by tailoring interventions to each person's specific biological needs, potentially leading to better health outcomes. ^{1 2 3 5 8}

Research Team

Momchilo Vuyisich

Principal Investigator

Viome Life Sciences

Eligibility Criteria

This trial is for US residents aged 25-75 with obesity, defined as a BMI of 30+ and waist-to-hip ratio over 1. Participants must be able to follow instructions, speak English, and use Viome's App on a smartphone. Exclusions include GERD sufferers, recent mothers or pregnant women, those with certain medical conditions like IBD or liver disease, and anyone on specific diets or medications that could interfere.

Inclusion Criteria

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

Willing and able to follow the trial instructions, as described in the recruitment letter

Resident of the United States

Exclusion Criteria

I am not willing to visit Quest for tests.

I have not had cancer treatment in the last year.

I am taking medication that could interact with the trial's supplements.

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 metabolic wellness

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. It involves completing surveys and being randomly assigned to one of three groups without clinical site visits. The aim is to see if these interventions can improve metabolic health in obese individuals.

Participant Groups

Group I: Viome's Precision Nutrition Program Active Control 1 Intervention

Participants may be provided with any combination of nutritional recommendations and supplements. The participants are asked to take the supplements on a daily basis.

Group II: Viome's condition-based supplements Active Control 1 Intervention

Participants may be provided with any combination of nutritional recommendations and they receive condition based supplements. The participants are asked to take the supplements on a daily basis.

Group III: Placebo Active Control 1 Intervention

Participants may be provided with any combination of nutritional recommendations and they receive placebo supplements. Placebo capsules will contain inert and inactive materials. The participants are asked to take the supplements on a daily basis.

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

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]

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 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) is defined as a field that uses individual differences to create nutrition strategies aimed at preventing and managing diseases while optimizing health, emphasizing the need for a clear consensus to enhance research and clinical practice.

The field of PN can be divided into three key areas: science and data, education and training, and guidance and therapeutics, which together help healthcare professionals tailor nutrition interventions to individual needs and improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward the Definition of Personalized Nutrition: A Proposal by The American Nutrition Association. Bush, CL., Blumberg, JB., El-Sohemy, A., et al.[2021]

Current nutritional recommendations lack sufficient data for both group-level and individualized dietary guidance, highlighting a significant gap in the field.

Emerging technologies like genomics, proteomics, and metabolomics hold the potential to revolutionize personalized nutrition, but they are not yet widely utilized in practice, necessitating better education and interdisciplinary collaboration among nutritionists and scientists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized nutritional recommendations: do we have the measurements needed to assess risk and make dietary recommendations? Arab, L.[2008]

Nutritional genomics explores how our genes and diet interact to influence health, but the use of genetic testing for personalized dietary advice is not yet ready for routine practice among dietitians, as it requires advanced knowledge and skills.

Chronic diseases are influenced by multiple genes and factors, making genetic mutations only partially predictive of disease risk; thus, dietitians should consider family history and other health indicators when personalizing dietary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Position of the Academy of Nutrition and Dietetics: nutritional genomics. Camp, KM., Trujillo, E.[2021]

Personalized nutrition is becoming more feasible due to advancements in technology and science, allowing dietary recommendations to be tailored to individual health needs and goals.

A systems biology approach is essential for creating effective personalized nutrition plans, as it considers the complex interactions between biological processes, nutrients, and environmental factors, enabling real-time adjustments to dietary recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systems biology of personalized nutrition. van Ommen, B., van den Broek, T., de Hoogh, I., et al.[2018]

References

1. 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]

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

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

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

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

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

Toward the Definition of Personalized Nutrition: A Proposal by The American Nutrition Association. [2021]

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

Individualized nutritional recommendations: do we have the measurements needed to assess risk and make dietary recommendations? [2008]

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

Position of the Academy of Nutrition and Dietetics: nutritional genomics. [2021]

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

Systems biology of personalized nutrition. [2018]