Precision Nutrition Program for Diabetes

Recruiting at 1 trial location

Overseen By Mory Mehrtash

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Viome

Must not be taking: Sulfonylureas, Exogenous insulin, Diet pills

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

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of Viome's Precision Nutrition Program (VPNP) in lowering blood sugar levels (HbA1c) in individuals with diabetes. Participants will be randomly assigned to either the VPNP or a placebo, which lacks active ingredients but may include general health advice. The trial seeks individuals with blood sugar levels (HbA1c) between 5.7% and 8.9% who can use a smartphone and app. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance diabetes management.

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.

Is there any evidence suggesting that Viome's Precision Nutrition Program (VPNP) is likely to be safe for humans?

Research has shown that Viome's Precision Nutrition Program (VPNP) is generally safe. In studies where participants followed personalized nutrition advice, various health areas improved, including a 36% improvement in severe depression cases. While these studies primarily assess the program's effectiveness, they also suggest it is well-tolerated.

The trial is now in a phase where researchers consider the treatment safe enough for larger groups. No specific negative effects have been reported, which is encouraging. However, individual experiences may vary. Consulting a healthcare provider is always advisable to determine if participation is suitable. ^{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 takes a personalized approach to managing blood sugar levels. Unlike traditional treatments like medications or insulin therapy, VPNP provides customized nutritional recommendations and supplements based on individual needs, which could lead to more effective management of HbA1c levels. Additionally, the use of mobile app technology in VPNP allows for easy tracking and adjustments, making it a modern and accessible solution for patients. This innovative method has the potential to improve diabetes management by addressing the unique dietary and lifestyle factors affecting each individual.

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, might improve how the body processes food. Studies have found that personalized nutrition plans can significantly lower HbA1c levels, an important measure of blood sugar control. In conditions like irritable bowel syndrome (IBS), Viome's program has led to noticeable health improvements, suggesting it might also help manage diabetes. By customizing nutrition advice to fit individual needs, the program aims to make it easier to control and possibly lower blood sugar levels. ^{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 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.

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

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.

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 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 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.

How Is the Trial Designed?

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.

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

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]

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]

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 (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]

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]

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]

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]

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]

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

Clinical Research Studies | Viome At Viome Life Sciences, we have developed a personalized nutrition program whose goal is to reduce HbA1c levels. The primary objective of this clinical trial is ...

4. clinicaltrial.be clinicaltrial.be/en/details/14362?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Viome Nutritional Programs to Improve Clinical Outcomes f... 2. Efficacy of VIOME Precision Nutrition Program (VPNP). Number of participants that show an improvement in metabolic health compared to ...

5. 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 ...

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. researchgate.net researchgate.net/publication/351196422_Evidence-based_precision_nutrition_improves_clinical_outcomes_by_analyzing_human_and_microbial_molecular_data_with_artificial_intelligence

(PDF) Evidence-based precision nutrition improves clinical ... We show that our precision nutritional recommendations resulted in improvements in clinical outcomes by 36% in severe cases of depression, 40% ...