Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c

Part of paid clinical trials in Bothell, Washington.

Sponsor
Viome
Study ID
NCT05465616
Status
Recruiting
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Conditions

  • Diabetes
  • Pre Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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 Details

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.

Key Dates

Start date
Aug 22, 2022
Status verified
Jan 2025
Primary completion
Dec 13, 2026
Completion
Dec 13, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

HbA1c Levels [ Time Frame: 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Viome Life SciencesBothellWashington98011
Momchilo Vuyisich, PhD
[email protected]
425-300-6933
Mory Mehrtash, MSc
[email protected]
(425) 300-6933
Momchilo Vuyisich, PhD (PRINCIPAL_INVESTIGATOR)

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