Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-13

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

NCT05465616

Diabetes Pre Diabetes

RECRUITING NA

Resveratrol-Leucine Metabolite Synergy in Pre-diabetes

NCT01593605

Impaired Glucose Tolerance

COMPLETED NA

Dietary Intervention in Type-2 Diabetes and Pre-Diabetes

NCT02519309

Diabetes Mellitus, Type 2 Pre-diabetes Metabolic Syndrome

COMPLETED NA

Diabetes Visual Function Supplement Study

NCT01646047

Diabetes Mellitus - Type 1 Diabetes Mellitus - Type 2 Non-proliferative Diabetic Retinopathy

COMPLETED NA

Practice Based Nutrition Intervention-2

NCT01700868

Diabetes Mellitus, Type 2

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a randomized, placebo-controlled trial that will test the efficacy of VPNP in reducing HbA1c. Participants with HbA1c levels between 6.5-8.9% (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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participants will be blinded for this study.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Participants with HbA1c levels between 6.5-8.9% (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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Viome's Precision Nutrition Program (VPNP)

Participants with HbA1c levels between 6.5-8.9% (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.

Group Type EXPERIMENTAL

Viome's Precision Nutrition Program (VPNP)

Intervention Type DIETARY_SUPPLEMENT

Nutrition, diet, and possible coaching through Viome application. Precision supplement based on the participants microbiome sample results.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Viome's Precision Nutrition Program (VPNP)

Nutrition, diet, and possible coaching through Viome application. Precision supplement based on the participants microbiome sample results.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 6.5-8.9% (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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No