Viome Nutritional Programs to Improve Clinical Outcomes for Metabolic Conditions

Part of paid clinical trials in Bothell, Washington.

Sponsor
Viome
Study ID
NCT05564273
Status
Recruiting
Apply to this trial

Conditions

  • Metabolic Health

Eligibility Criteria

Sex
ALL
Age
25 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • VIOME Precision Nutrition Program — COMBINATION_PRODUCT
    Precision supplement based on the participants microbiome sample results. Participants in this arm may receive supplements, diet recommendations, and app coaching.
  • VIOME-designed condition-based supplements — DIETARY_SUPPLEMENT
    Pre-formulated supplements based on overall health conditions. Participants in this arm may receive supplements, diet recommendations, and app coaching.

Study Details

US residents who have obesity and sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of three arms. This study is direct to participant and will not utilize clinical sites.

Key Dates

Start date
Oct 13, 2023
Status verified
Jan 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • No Intervention: Placebo
    Participants may be provided with any combination of nutritional recommendations and they receive placebo supplements. Placebo capsules will contain inert and inactive materials. The participants are asked to take the supplements on a daily basis.
  • Active Comparator: Viome's Precision Nutrition Program
    Participants may be provided with any combination of nutritional recommendations and supplements. The participants are asked to take the supplements on a daily basis.
  • Active Comparator: Viome's condition-based supplements
    Participants may be provided with any combination of nutritional recommendations and they receive condition based supplements. The participants are asked to take the supplements on a daily basis.

Primary Outcome Measure

Efficacy of VIOME's designed condition based supplements (VCS) [ Time Frame: ~4months ]

Central Contacts

Locations (1)

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

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