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Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

Primary Purpose

Diabetes, Pre Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Viome's Precision Nutrition Program (VPNP)
Sponsored by
Viome
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring Health, Wellness, Nutrition, Vitamins, Supplements, Prebiotics, Probiotics, Fitness, Blood sugar

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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% and 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

Sites / Locations

  • AdventHealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Placebo

Viome's Precision Nutrition Program (VPNP)

Arm Description

Participants with HbA1c levels between 5.7% and 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.

Participants with HbA1c levels between 5.7% and 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.

Outcomes

Primary Outcome Measures

HbA1c Levels
HbA1c changes in individuals in the interventional arm compared to baseline measurement.

Secondary Outcome Measures

Insulin Resistance
Change in fasting insulin levels in those in the interventional arm compared to baseline measurement.
BMI
Changes in BMI of individuals in the interventional arm compared to baseline measurement.
Cholesterol
Changes in HDL, LDL, total cholesterol, and triglyceride levels of those in the interventional arm compared to baseline measurements.
Waist to Hip Ratio
Changes in waist to hip ratio of those in the interventional group compared to baseline measurement.
Cardiovascular Risk
Changes to 10 year cardiovascular risk score of those in the interventional arm compared to baseline score.
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.
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.
Species prevalence in stool, blood, and saliva
Changes in the prevalence of species in stool, blood, and saliva samples compared to baseline analysis.

Full Information

First Posted
July 8, 2022
Last Updated
January 16, 2023
Sponsor
Viome
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1. Study Identification

Unique Protocol Identification Number
NCT05465616
Brief Title
Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c
Official Title
Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Viome

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a randomized, placebo-controlled trial that will test the efficacy of VPNP in reducing HbA1c. Participant recruitment will occur at AdventHealth in Orlando, FL or 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. Up to 400 participants with HbA1c levels between 5.7% and 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 and either personalized supplements or placebo supplements. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Pre Diabetes
Keywords
Health, Wellness, Nutrition, Vitamins, Supplements, Prebiotics, Probiotics, Fitness, Blood sugar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Participants (and care providers, if referred through AdventHealth) will be blinded for this study.
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
No Intervention
Arm Description
Participants with HbA1c levels between 5.7% and 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.
Arm Title
Viome's Precision Nutrition Program (VPNP)
Arm Type
Experimental
Arm Description
Participants with HbA1c levels between 5.7% and 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Viome's Precision Nutrition Program (VPNP)
Intervention Description
Nutrition, diet, and possible coaching through Viome application. Precision supplement based on the participants microbiome sample results.
Primary Outcome Measure Information:
Title
HbA1c Levels
Description
HbA1c changes in individuals in the interventional arm compared to baseline measurement.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Insulin Resistance
Description
Change in fasting insulin levels in those in the interventional arm compared to baseline measurement.
Time Frame
4 months
Title
BMI
Description
Changes in BMI of individuals in the interventional arm compared to baseline measurement.
Time Frame
4 months
Title
Cholesterol
Description
Changes in HDL, LDL, total cholesterol, and triglyceride levels of those in the interventional arm compared to baseline measurements.
Time Frame
4 months
Title
Waist to Hip Ratio
Description
Changes in waist to hip ratio of those in the interventional group compared to baseline measurement.
Time Frame
4 months
Title
Cardiovascular Risk
Description
Changes to 10 year cardiovascular risk score of those in the interventional arm compared to baseline score.
Time Frame
4 months
Title
Patient Health Questionnaire 9 (PHQ 9) Score
Description
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.
Time Frame
4 months
Title
General Anxiety Disorder - 7 Score
Description
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.
Time Frame
4 months
Title
Species prevalence in stool, blood, and saliva
Description
Changes in the prevalence of species in stool, blood, and saliva samples compared to baseline analysis.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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% and 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colin MacKichan
Phone
(425) 300-6933
Email
studies@viome.com
First Name & Middle Initial & Last Name or Official Title & Degree
Momchilo Vuyisich
Phone
(425) 300-6933
Email
studies@viome.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Momchilo Vuyisich
Organizational Affiliation
Viome
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Saadia Alvi, MD
Organizational Affiliation
AdventHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
AdventHealth
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saadia Alvi, MD
Phone
407-303-2801
First Name & Middle Initial & Last Name & Degree
Momchilo Vuyisich, PhD
Email
studies@viome.com
First Name & Middle Initial & Last Name & Degree
Saadia Alvi, MD
First Name & Middle Initial & Last Name & Degree
Damon Tanton, MD

12. IPD Sharing Statement

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Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

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