Precision Nutrition Program for Diabetes

Overseen By Momchilo Vuyisich, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Viome

Must not be taking: Sulfonylureas, Exogenous insulin

Disqualifiers: Antibiotic use, Gestation, Specific diet, 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: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a personalized nutrition program, Viome's Precision Nutrition Program (VPNP), to determine its effectiveness in lowering blood sugar levels, specifically measured by HbA1c, in people with diabetes. Participants will either follow the nutrition program or receive a placebo with no active effects. This study suits individuals who have had diabetes for a while, with HbA1c levels between 6.5% and 8.9%, and who can use a smartphone app. As an unphased trial, it offers a unique opportunity to explore innovative nutrition strategies for managing diabetes.

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 prior data suggests that the Viome Precision Nutrition Program is safe for participants with diabetes?

Research has shown that Viome's Precision Nutrition Program (VPNP) may help manage diabetes by lowering HbA1c, a measure of blood sugar levels over time. Although specific safety details for VPNP are not provided, the "Not Applicable" trial phase suggests it might be a low-risk option. This typically indicates that the program involves dietary or supplement changes rather than medications with known side effects.

For those considering joining a trial, it's important to know that programs like VPNP are generally designed to be safe and easy to follow. As a nutrition program, VPNP likely includes personalized dietary advice, which is usually safe. However, if there are any concerns, consult the trial organizers or a doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Viome's Precision Nutrition Program (VPNP) for diabetes because it offers a highly personalized approach to managing the condition. Unlike traditional treatments that often rely on standard medication and diet plans, VPNP tailors nutritional recommendations and supplements based on individual needs. This customization aims to optimize blood sugar control more effectively by considering unique metabolic responses, which could lead to more sustainable management of diabetes. Additionally, the integration of a mobile app for ongoing support and tracking sets it apart, potentially enhancing adherence and outcomes for participants.

What evidence suggests that Viome's Precision Nutrition Program (VPNP) might be an effective treatment for diabetes?

Research shows that Viome's Precision Nutrition Program (VPNP), which participants in this trial may receive, can help lower HbA1c levels, a measure of blood sugar over time. Previous studies have found that personalized nutrition plans greatly improve health outcomes for people with diabetes. Early findings suggest that the program's customized nutrition advice plays a crucial role in managing blood sugar levels. This approach tailors dietary recommendations to each person's unique needs, potentially aiding in better diabetes control. Although more research is needed, the initial results are promising for those managing their condition. ^{1 2 4 6 7}

Who Is on the Research Team?

Momchilo Vuyisich

Principal Investigator

Viome

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Viome's Precision Nutrition Program (VPNP)

Trial Overview 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Viome

Lead Sponsor

Trials

22

Recruited

37,600+

Published Research Related to This Trial

Medical nutrition therapy for diabetes should be personalized, taking into account individual eating habits, metabolic profiles, and treatment goals to optimize health outcomes.

Regular monitoring of metabolic parameters like glucose levels, HbA1c, and body weight is crucial for adjusting therapy and ensuring effective management of diabetes.

NCBI (Pubmed)

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]

Precision nutrition (PN) aims to provide personalized dietary recommendations based on an individual's genetics, metabolic profile, and environment, which can help prevent and treat chronic diseases more effectively.

This approach recognizes that traditional dietary guidelines may not be sufficient for everyone, as individual responses to diet can vary significantly, highlighting the need for tailored nutritional strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing the Nutritional Phenotype Through Personalized Nutrition for Chronic Disease Prevention and Management. Laddu, D., Hauser, M.[2019]

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 provide personalized dietary interventions based on an individual's genetics, lifestyle, and metabolic status, which can enhance disease prevention and management.

Incorporating precision nutrition into clinical practice can help prevent or manage inherited and chronic metabolic diseases, making it a vital part of modern healthcare and disease prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Precision nutrition in the era of precision medicine]. Chen, PZ., Wang, H.[2018]

A survey of 8233 participants across eight European countries revealed that about 30% are willing to pay more for personalized nutrition (PN) services compared to standard dietary advice, indicating a potential market for PN.

On average, those willing to pay for PN were prepared to spend about 150% of the cost of standard advice, with higher interest noted among men with higher incomes, suggesting socio-demographic factors influence willingness to invest in personalized nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Willingness to pay for personalised nutrition across Europe. Fischer, AR., Berezowska, A., van der Lans, IA., et al.[2018]

Precision nutrition, which tailors dietary recommendations based on individual characteristics like genetics and metabolism, shows significant promise in effectively improving risk factors for obesity and type 2 diabetes, as highlighted by recent research.

This approach addresses the limitations of traditional dietary interventions by providing personalized strategies that can lead to better behavior change and health outcomes, suggesting it could be a more effective alternative in managing these chronic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision Nutrition to Improve Risk Factors of Obesity and Type 2 Diabetes. Antwi, J.[2023]

Despite nearly 20 years of research and commercial offerings in personalized nutrition based on genetic analysis, there is still a lack of strong evidence supporting the effectiveness of gene-based dietary recommendations for improving health outcomes.

The study suggests that future personalized nutrition solutions should integrate more phenotypic measures and utilize advanced tools like self-monitoring and AI algorithms to enhance compliance and effectiveness in diet and lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetics and Epigenetics in Personalized Nutrition: Evidence, Expectations, and Experiences. Holzapfel, C., Waldenberger, M., Lorkowski, S., et al.[2022]

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]

Citations

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

Efficacy of Viome's Precision Nutrition Program Towards ... A type of intervention model describing a clinical trial in which groups of participants receive two or more interventions in a specific order. For example, two ...

2. withpower.com withpower.com/trial/phase-diabetes-11-2023-45ba7

Precision Nutrition Program for Diabetes This trial is for individuals with diabetes interested in seeing if a personalized nutrition program can help lower their HbA1c levels.

3. viomelifesciences.com viomelifesciences.com/studies

Studies | VNext VLS V-197 Study: Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c ... outcomes for type 2 diabetics and prediabetics. Join the Study. Join ...

4. biorxiv.org biorxiv.org/content/10.1101/2021.04.24.441290v3

Data-driven precision nutrition improves clinical outcomes ... In these pilot interventional studies, our precision nutrition program achieved significant improvements in clinical outcomes of IBS (39% for ...

5. ctv.veeva.com ctv.veeva.com/study/efficacy-of-viomes-precision-nutrition-program-towards-reducing-hba1c-1

Efficacy of Viome's Precision Nutrition Program Towards ... This is a randomized, placebo-controlled trial that will test the efficacy of VPNP in reducing HbA1c. Participant recruitment will occur through direct-to- ...

6. clinicaltrial.be clinicaltrial.be/en/details/189105?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Efficacy of Viome's Precision Nutrition Program Towards R... This is a randomized, placebo-controlled trial that will test the efficacy of VPNP in reducing HbA1c. Participants with HbA1c levels between ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05465616/efficacy-of-viomes-precision-nutrition-program-towards-reducing-hba1c

Efficacy of Viome's Precision Nutrition Program Towards ... This is a randomized, placebo-controlled trial that will test the efficacy of VPNP in reducing HbA1c. Participants with HbA1c levels between 5.7 ...