Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

Diabetes Clinical Trial

Official title:

Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05465616
• Other study ID #: V197
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 23, 2022
• Est. completion date: March 2025

Study information

• Verified date: December 2023
• Source: Viome
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: March 2025
• Est. primary completion date: December 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Pre Diabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
United States	Viome Life Sciences	Bothell	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Viome

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c Levels	HbA1c changes in individuals in the interventional arm compared to baseline measurement.	4 months
Primary	Insulin Resistance	Change in fasting insulin levels in those in the interventional arm compared to baseline measurement.	4 months
Secondary	BMI	Changes in BMI of individuals in the interventional arm compared to baseline measurement.	4 months
Secondary	Cholesterol	Changes in HDL, LDL, total cholesterol, and triglyceride levels of those in the interventional arm compared to baseline measurements.	4 months
Secondary	Waist to Hip Ratio	Changes in waist to hip ratio of those in the interventional group compared to baseline measurement.	4 months
Secondary	Cardiovascular Risk	Changes to 10 year cardiovascular risk score of those in the interventional arm compared to baseline score.	4 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Fasting glucose	Fasting glucose changes in individuals in the interventional arm compared to baseline measurement.	4 months