DiabetesNCT05465616
Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c
A study testing Viome's Precision Nutrition Program (VPNP) in people with Diabetes and Pre Diabetes, run by Viome at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Pre Diabetes
- What is being tested?
- Viome's Precision Nutrition Program (VPNP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2022to 13 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Viome Life Sciences
Bothell, Washington, 98011
Momchilo Vuyisich, PhD, 425-300-6933, studies@viome.com
Mory Mehrtash, MSc, (425) 300-6933, studies@viome.com
About this study
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.
Read the 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.
- Conditions
- Diabetes, Pre Diabetes
- Being tested
- Viome's Precision Nutrition Program (VPNP)
- Keywords
- Health, Wellness, Nutrition, Vitamins, Supplements, Prebiotics, Probiotics, Fitness, Blood sugar
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viome's Precision Nutrition Program (VPNP)Dietary supplement
Nutrition, diet, and possible coaching through Viome application. Precision supplement based on the participants microbiome sample results.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | No intervention | 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. |
| Viome's Precision Nutrition Program (VPNP) | Experimental | 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. Receives: Dietary Supplement: Viome's Precision Nutrition Program (VPNP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c Levels
HbA1c changes in individuals in the interventional arm compared to baseline measurement.
Measured: 4 months
Insulin Resistance
Change in fasting insulin levels in those in the interventional arm compared to baseline measurement.
Measured: 4 months
Secondary outcomes (8)
BMI
Changes in BMI of individuals in the interventional arm compared to baseline measurement.
Measured: 4 months
Cholesterol
Changes in HDL, LDL, total cholesterol, and triglyceride levels of those in the interventional arm compared to baseline measurements.
Measured: 4 months
Waist to Hip Ratio
Changes in waist to hip ratio of those in the interventional group compared to baseline measurement.
Measured: 4 months
Cardiovascular Risk
Changes to 10 year cardiovascular risk score of those in the interventional arm compared to baseline score.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 months
Fasting glucose
Fasting glucose changes in individuals in the interventional arm compared to baseline measurement.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start22 Aug 2022
- Primary completion13 Dec 2026 (estimated)
- Study completion13 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by ViomeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viome
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Momchilo Vuyisich, Principal investigator, Viome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465616
- Sponsor's protocol ID
- V197
- Status last verified
- Jan 2025
- First submitted
- 8 Jul 2022
- Last updated
- 24 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c
- ClinicalTrials.gov ID
- NCT05465616
- Acronym / sponsor ID
- V197
- Conditions
- Diabetes, Pre Diabetes
- Keywords
- Health, Wellness, Nutrition, Vitamins, Supplements, Prebiotics, Probiotics, Fitness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- ViomeIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 13 Dec 2026 (estimated)
- Study completion
- 13 Dec 2026 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | No intervention | –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. |
| Viome's Precision Nutrition Program (VPNP) | Experimental | Dietary Supplement: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viome's Precision Nutrition Program (VPNP)Nutrition, diet, and possible coaching through Viome application. Precision supplement based on the participants microbiome sample results. | Dietary supplement | Viome's Precision Nutrition Program (VPNP) |
Primary outcome
HbA1c Levels
Time frame: 4 months
HbA1c changes in individuals in the interventional arm compared to baseline measurement.
Insulin Resistance
Time frame: 4 months
Change in fasting insulin levels in those in the interventional arm compared to baseline measurement.
8 secondary outcomes
BMI
Time frame: 4 months
Cholesterol
Time frame: 4 months
Waist to Hip Ratio
Time frame: 4 months
Cardiovascular Risk
Time frame: 4 months
Patient Health Questionnaire 9 (PHQ 9) Score
Time frame: 4 months
General Anxiety Disorder - 7 Score
Time frame: 4 months
Species prevalence in stool, blood, and saliva
Time frame: 4 months
Fasting glucose
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Momchilo Vuyisich principal investigator
Viome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Viome's Precision Nutrition Program (VPNP) in people with Diabetes and Pre Diabetes, run by Viome at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mory Mehrtash ((425) 300-6933, studies@viome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c Levels (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.