Recruiting

Viome's Precision Nutrition

Sponsor:

Viome

Code:

NCT05465616

Conditions

Diabetes

Pre Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Viome's Precision Nutrition Program (VPNP)

Study Details

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.

Conditions

Diabetes

Pre Diabetes

Study ID

NCT05465616

Start date

Aug 22, 2022

Status verified date

Jan, 2025

Completion date

Dec 13, 2026

Anticipated

Primary completion date

Dec 13, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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 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

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Placebo

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.

experimental: 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.

Interventions

Viome's Precision Nutrition Program (VPNP)

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

Primary outcome measure

  • HbA1c Levels [ Time Frame: 4 months ]
  • Insulin Resistance [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Mory Mehrtash

(425) 300-6933studies@viome.com

Momchilo Vuyisich

(425) 300-6933studies@viome.com

Locations

Viome Life Sciences

Recruiting

Bothell, Washington, United States, 98011

Contacts

Momchilo Vuyisich, PhD

425-300-6933studies@viome.com

Mory Mehrtash, MSc

(425) 300-6933studies@viome.com

Principal Investigator:

Momchilo Vuyisich, PhD

More Information

Sponsor

Viome

Last update posted

Jan 24, 2025

Last verified

Jan, 2025

Keywords

  • Health
  • Wellness
  • Nutrition
  • Vitamins
  • Supplements
  • Prebiotics
  • Probiotics
  • Fitness
  • Blood sugar

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Viome on 2025-01-24.