Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

Not Applicable

Recruiting

• Conditions: Pre Diabetes; Diabetes

• Registration Number: NCT05465616
• Lead Sponsor: Viome

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-07-08
• Study First Submitted QC: 2022-07-15
• Study First Posted: 2022-07-20
• Study Start: 2022-08-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-24
• Primary Completion: 2026-12-13
• Study Completion: 2026-12-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c Levels	4 months	HbA1c changes in individuals in the interventional arm compared to baseline measurement.
Insulin Resistance	4 months	Change in fasting insulin levels in those in the interventional arm compared to baseline measurement.

Secondary Outcome Measures

Name	Time	Method
BMI	4 months	Changes in BMI of individuals in the interventional arm compared to baseline measurement.
General Anxiety Disorder - 7 Score	4 months	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.
Fasting glucose	4 months	Fasting glucose changes in individuals in the interventional arm compared to baseline measurement.
Patient Health Questionnaire 9 (PHQ 9) Score	4 months	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.
Species prevalence in stool, blood, and saliva	4 months	Changes in the prevalence of species in stool, blood, and saliva samples compared to baseline analysis.
Cholesterol	4 months	Changes in HDL, LDL, total cholesterol, and triglyceride levels of those in the interventional arm compared to baseline measurements.
Waist to Hip Ratio	4 months	Changes in waist to hip ratio of those in the interventional group compared to baseline measurement.
Cardiovascular Risk	4 months	Changes to 10 year cardiovascular risk score of those in the interventional arm compared to baseline score.

Trial Locations

Locations (1)

Viome Life Sciences; 🇺🇸 Bothell, Washington, United States