Precision Nutrition Program for Diabetes

Recruiting in Palo Alto (17 mi)

+1 other location

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, Diet pills

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 personalized diet advice and supplements can lower blood sugar levels in people with slightly elevated blood sugar. People will follow tailored recommendations for three months, and their health will be checked before and after the trial.

Will I have to stop taking my current medications?

If you are currently using medications that increase insulin or exogenous insulin, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of the treatment Viome's Precision Nutrition Program (VPNP) 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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

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

The Viome Precision Nutrition Program is unique because it uses precision nutrition, which tailors dietary recommendations based on an individual's genetic makeup, metabolic profile, and gut microbiome. This personalized approach aims to optimize dietary response and improve health outcomes, unlike traditional one-size-fits-all dietary guidelines. ^{1 2 5 6 8}

Research Team

Momchilo Vuyisich

Principal Investigator

Viome

Eligibility Criteria

This trial is for English-speaking adults aged 18 or older with HbA1c levels between 5.7% and 8.9%. Participants must be able to visit a Quest Diagnostics center, follow the nutrition program, use a smartphone with Viome's app, and not have used certain diabetes medications or been on specific diets recently.

Inclusion Criteria

I can use a smartphone and the Viome app.

I am willing and able to follow the trial's diet and instructions.

I am 18 years old or older.

Exclusion Criteria

I have not taken antibiotics within the last month.

I am using or have used insulin injections for my diabetes.

You have been following a specific diet, like the ketogenic diet, within the past month to lower your HbA1c levels or lose weight.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dietary recommendations and 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

Treatment Details

Interventions

• Viome's Precision Nutrition Program (VPNP) (Dietary Supplement)

Trial Overview The trial is testing Viome's Precision Nutrition Program (VPNP) to see if it can lower HbA1c in people with diabetes or prediabetes. It's randomized and placebo-controlled, meaning some people will get VPNP while others won't, decided by chance.

Participant Groups

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

Participants with HbA1c levels between 5.7-8.9% (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 5.7-8.9% (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.

Who Is Running the Clinical Trial?

Viome

Lead Sponsor

Trials

22

Recruited

37,600+

Findings from Research

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]

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]

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]

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]

References

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

Addressing the Nutritional Phenotype Through Personalized Nutrition for Chronic Disease Prevention and Management. [2019]

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. China pubmed.ncbi.nlm.nih.gov

[Precision nutrition in the era of precision medicine]. [2018]

4. 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]

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

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

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

Genetics and Epigenetics in Personalized Nutrition: Evidence, Expectations, and Experiences. [2022]

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

Willingness to pay for personalised nutrition across Europe. [2018]

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

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