100 Participants Needed

Precision Nutrition Program for Diabetes

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Momchilo Vuyisich, PhD profile photo
Momchilo Vuyisich, PhD profile photo
Overseen ByMomchilo Vuyisich, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests if tailored nutrition and supplements can help people with moderately high blood sugar. Participants will follow specific diet plans and take special supplements for a few months. The goal is to see if these treatments can improve their blood sugar control.

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.

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.12345

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

Viome's Precision Nutrition Program is unique because it uses a personalized approach, tailoring dietary recommendations based on an individual's genetic makeup, metabolic profile, and gut microbiome. This precision nutrition strategy aims to optimize dietary response and health, potentially offering a more effective alternative to conventional diabetes treatments that do not account for individual variability.12367

What data supports the effectiveness of the Viome's Precision Nutrition Program (VPNP) treatment 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.23578

Who Is on the Research Team?

MV

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)
See 3 more

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
See 7 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Viome's Precision Nutrition Program (VPNP)Experimental Treatment1 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: PlaceboActive Control1 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

Find a Clinic Near You

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.
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 (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.
Addressing the Nutritional Phenotype Through Personalized Nutrition for Chronic Disease Prevention and Management.Laddu, D., Hauser, M.[2019]
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.
American Diabetes Association position statement: evidence-based nutrition principles and recommendations for the treatment and prevention of diabetes and related complications.[2022]

Citations

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]
Addressing the Nutritional Phenotype Through Personalized Nutrition for Chronic Disease Prevention and Management. [2019]
American Diabetes Association position statement: evidence-based nutrition principles and recommendations for the treatment and prevention of diabetes and related complications. [2022]
[Precision nutrition in the era of precision medicine]. [2018]
Toward the Definition of Personalized Nutrition: A Proposal by The American Nutrition Association. [2021]
Genetics and Epigenetics in Personalized Nutrition: Evidence, Expectations, and Experiences. [2022]
Willingness to pay for personalised nutrition across Europe. [2018]
Precision Nutrition to Improve Risk Factors of Obesity and Type 2 Diabetes. [2023]
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