Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

This is a randomized, placebo-controlled trial that will test the efficacy of VPNP in reducing HbA1c. Participant recruitment will occur through direct-to-participant enrollment. No additional clinical sites will be used for recruitment.

Study Overview

• Status: Recruiting
• Conditions: Diabetes; Pre Diabetes
• Intervention / Treatment: Dietary supplement: Viome's Precision Nutrition Program (VPNP)

Detailed Description

This is a randomized, placebo-controlled trial that will test the efficacy of VPNP in reducing HbA1c. Participants with HbA1c levels between 5.7-8.9% (inclusive) will be recruited and randomized into either the placebo or intervention group. The study duration for each participant will be approximately 90 days. At the beginning of the 90 days, the participant will complete online questionnaires, a blood draw, and a set of at-home sample collections for blood, stool, and saliva that will be sent back to Viome. After the samples are analyzed, the participant will receive dietary recommendations (either personalized or USDA) and supplements (either personalized or placebo). The participant will follow the dietary recommendations and take the supplements for 90 days. At the end of the 90 days, the participant will once again complete online questionnaires, a blood draw, and a set of at-home sample collections for blood, stool, and saliva that will be sent back to Viome for analysis.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Momchilo Vuyisich; Phone Number: (425) 300-6933; Email: studies@viome.com
• Study Contact Backup: Name: Mory Mehrtash; Phone Number: (425) 300-6933; Email: studies@viome.com

Study Locations

• United States
  • Washington
    • Bothell, Washington, United States, 98011
      • Recruiting
      • Viome Life Sciences
      • Principal Investigator: Momchilo Vuyisich, PhD
      • Contact: Momchilo Vuyisich, PhD; Phone Number: 425-300-6933; Email: studies@viome.com
      • Contact: Mory Mehrtash, MSc; Phone Number: (425) 300-6933; Email: studies@viome.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Placebo; 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.
Experimental: Viome's Precision Nutrition Program (VPNP); 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.	Dietary supplement: Viome's Precision Nutrition Program (VPNP); Nutrition, diet, and possible coaching through Viome application. Precision supplement based on the participants microbiome sample results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c Levels	HbA1c changes in individuals in the interventional arm compared to baseline measurement.	4 months
Insulin Resistance	Change in fasting insulin levels in those in the interventional arm compared to baseline measurement.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	Changes in BMI of individuals in the interventional arm compared to baseline measurement.	4 months
Cholesterol	Changes in HDL, LDL, total cholesterol, and triglyceride levels of those in the interventional arm compared to baseline measurements.	4 months
Waist to Hip Ratio	Changes in waist to hip ratio of those in the interventional group compared to baseline measurement.	4 months
Cardiovascular Risk	Changes to 10 year cardiovascular risk score of those in the interventional arm compared to baseline score.	4 months
Patient Health Questionnaire 9 (PHQ 9) Score	Changes in PHQ9 score of those in the interventional arm compared to baseline answers. The minimum PHQ 9 score is 0 and the maximum PHQ 9 score is 27. Higher scores indicate a worse outcome.	4 months
General Anxiety Disorder - 7 Score	Changes in GAD7 score in those in the interventional arm compared to baseline assessment. The minimum score on GAD 7 is 0-4 indicating none to minimal anxiety and the maximum score is 15-21 indicating sever anxiety. Higher scores indicate a worse outcome.	4 months
Species prevalence in stool, blood, and saliva	Changes in the prevalence of species in stool, blood, and saliva samples compared to baseline analysis.	4 months
Fasting glucose	Fasting glucose changes in individuals in the interventional arm compared to baseline measurement.	4 months

Collaborators and Investigators

• Sponsor: Viome
• Investigators: Principal Investigator: Momchilo Vuyisich, Viome

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2022
• Primary Completion (Estimated): December 13, 2026
• Study Completion (Estimated): December 13, 2026

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Probiotics; Nutrition; Health; Fitness; Blood sugar; Prebiotics; Supplements; Vitamins; Wellness
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: V197

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No