What is Viome's Precision Nutrition Program studying for diabetes?

Viome's Precision Nutrition Program is being studied to see if it can help reduce HbA1c levels in adults with diabetes or prediabetes. The trial evaluates personalized nutrition and supplements based on microbiome analysis to better understand their impact on blood sugar control. Viome is sponsoring this research to explore new dietary approaches for managing these conditions.

Who may be eligible for this diabetes clinical trial?

Adults aged 18 years or older with HbA1c levels between 5.7% and 8.9% may be eligible. Both males and females who can read and speak English and are willing to use a smartphone app and visit a diagnostic center can participate. People who have recently used certain medications or antibiotics may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this diabetes clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or time commitments.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID05465616

Study of Viomes Personalized Nutrition Program to Lower Blood Sugar Levels in Adults with Pre-Diabetes or Diabetes

Led by Viome · Updated on 2025-01-24

150

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of Viomes Precision Nutrition Program VPNP in reducing HbA1c levels in adults with diabetes or prediabetes. This randomized, placebo-controlled trial will recruit participants with HbA1c between 5.7% and 8.9% to assess changes in blood sugar control and insulin resistance over approximately 90 days. Participants will be randomly assigned to receive either personalized dietary recommendations and supplements through the VPNP or a placebo. At the start, participants complete online questionnaires and provide blood, stool, and saliva samples both in a lab and at home. After analysis, they follow assigned nutrition plans and take supplements or placebo for 90 days. Throughout the study, participants will complete questionnaires and sample collections again at the end of the 90-day period. Researchers will measure HbA1c, insulin resistance, BMI, cholesterol, waist-to-hip ratio, cardiovascular risk, mental health scores, species prevalence in samples, and fasting glucose. Participants may need to use a mobile app and visit a Quest Diagnostic center for some tests.

CONDITIONS

Brief Title

Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Signed and dated informed consent form and medical release prior to any trial-specific procedures
Females and males aged 18 years or older
Able to speak and read English
HbA1c between 5.7-8.9% (inclusive), tested within the past 30 days
Willing and able to visit a Quest Diagnostic Patient Service Center (PSC)
Willing and able to follow the trial instructions and Viome's Precision Nutrition Program
Willing and able to use a smartphone and Viome app.

You will not qualify if you...

Antibiotic use within one month of the GI test
Gestation within previous 6 month
Current (or previous) use of medications that increase insulin (sulfonylureas, such as glimepiride, glipizide, glyburide, etc.)
Current (or previous) use of exogenous insulin (such as Tresiba, Lantus, Toujeo, Levemir, Humalog, Novolog, Apidra, Fiasp, etc.)
On a specific diet, such as ketogenic, for the purpose of reducing HbA1c and/or weight within the previous month
Taking diet pills
Allergy to an ingredient in the MH capsule or stick pack
Currently on an investigational product
Significant surgery or medical procedure planned
Diet or lifestyle change during the trial period, besides those appropriate for trial arm Has followed Viome nutritional recommendations (foods and/or supplements)

Research Team

Mory Mehrtash

Momchilo Vuyisich

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Study of Viomes Personalized Nutrition Program to Lower Blood Sugar Levels in Adults with Pre-Diabetes or Diabetes

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria