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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different nutrition programs can improve metabolic health for individuals with obesity. Participants will be randomly assigned to receive either the VIOME Precision Nutrition Program (personalized nutrition plans with specific supplements), VIOME-designed condition-based supplements, or placebo supplements (inactive substances). The goal is to determine which approach best manages weight and related health concerns. The trial seeks U.S. residents who have recently experienced high fasting insulin or glucose levels and are willing to follow the study guidelines. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research in personalized nutrition and metabolic health.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Viome's Precision Nutrition Program is generally safe. The Habit Study found that personalized nutrition plans like Viome's can improve eating habits and health without causing harm, indicating that participants usually tolerate the treatment well.

Viome's condition-based supplements have also undergone testing for their effects on metabolic health. Studies focus on how these supplements can enhance health without major side effects. Although detailed information on side effects isn't provided, ongoing research emphasizes safety and effectiveness.

Overall, past research suggests both treatments are safe. However, consulting a healthcare professional before joining any trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Viome Precision Nutrition Program because it offers a personalized approach to improving metabolic health, unlike standard treatments that typically involve one-size-fits-all medications. This program uses precise nutritional recommendations and condition-specific supplements tailored to an individual's unique biology, aiming to optimize metabolic function. By focusing on personalized nutrition, this treatment has the potential to address root causes of metabolic issues rather than just managing symptoms, providing a more holistic and targeted intervention.

What evidence suggests that this trial's treatments could be effective for obesity?

Research shows that Viome's Precision Nutrition Program, a treatment arm in this trial, can improve health by supporting weight loss and promoting healthier eating habits. Personalized nutrition plans have helped people consume fewer calories and lose weight. Another treatment arm involves Viome's condition-based supplements, which rely on tests of gut bacteria and are designed to address specific health issues while enhancing these benefits. Together, these methods aim to improve overall well-being by meeting unique nutritional needs. Early studies suggest these treatments are safe and can lead to better health outcomes. ^{1 2 4 6 7}

Who Is on the Research Team?

Momchilo Vuyisich

Principal Investigator

Viome Life Sciences

Are You a Good Fit for This Trial?

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

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05465616

Efficacy of Viome's Precision Nutrition Program Towards ... At the beginning of the 90 days, the participant will complete online questionnaires, a blood draw, and a set of at-home sample collections for blood, stool, ...

2. viome.com viome.com/blog/understanding-your-viome-health-scores-cellular-energy-and-efficiency

Understanding Your Viome Health Scores: Cellular Energy ... Your Viome microbiome tests reveal personalized insights into your gut, cellular, and oral functioning. Our health scores provide a comprehensive overview.

3. withpower.com withpower.com/trial/phase-metabolic-health-8-2022-a3fb6

Viome Nutritional Programs for Metabolic Health Research suggests that personalized nutrition programs can improve dietary habits and health outcomes, such as reducing calorie intake, body weight, and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05564273

Study Details | NCT05564273 | Viome Nutritional Programs ... Number of participants that show an improvement in metabolic health compared to baseline survey assessment. ~4months. Efficacy of VIOME Precision Nutrition ...

5. viomelifesciences.com viomelifesciences.com/studies

Clinical Research Studies | Viome At Viome Life Sciences, we have developed a personalized nutrition program whose goal is to reduce gastrointestinal symptoms, such as abdominal pain, cramping, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11994916/

A Scoping Review of Artificial Intelligence for Precision Nutrition Health optimization in the field of precision nutrition aims to enhance individuals' well-being through personalized nutrition (or dietary) interventions using ...

7. trialx.com trialx.com/clinical-trials/listings/219985/viome-precision-nutritional-programs-to-improve-clinical-outcomes-for-mental-health-conditions/

Viome Precision Nutritional Programs to Improve Clinical ... Viome Precision Nutritional Programs to Improve Clinical Outcomes for Mental Health Conditions. Recruiting.