Actively Recruiting

Phase Not Applicable
Age: 25Years - 75Years
All Genders
NCT05564273

Viome Nutritional Programs to Improve Clinical Outcomes for Metabolic Conditions

Led by Viome · Updated on 2025-01-29

150

Participants Needed

1

Research Sites

163 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Viome Nutritional Programs to Improve Clinical Outcomes for Metabolic Conditions

Who Can Participate

Age: 25Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Resident of the United States
  • Female or male aged 25 to 75 years
  • Able to speak and read English
  • No unexplained weight loss, fevers, anemia, or blood in stool
  • Willing and able to follow the trial instructions
  • Signed and dated informed consent before any trial procedures
  • Fasting insulin level of 15 uIU/mL or higher or fasting glucose of 100 mg/dL or higher within the last 3 months, verified from medical records
Not Eligible

You will not qualify if you...

  • Unwilling to change current diet
  • Unwilling to go to Quest
  • Prior use of Viome products or services
  • Antibiotic use in the previous 4 weeks
  • Pregnant, breastfeeding, or less than 90 days postpartum
  • Active infection
  • Unable or unwilling to use Viome's app on an iPhone or Android smartphone
  • Significant diet or lifestyle changes in the previous month
  • Diagnosis of inflammatory bowel disease
  • Use of investigational drugs, products, or devices within 1 month before and 4 months after trial start
  • Cancer therapy within the previous year
  • Major surgery in the last 6 months or planned in the next 4 months
  • Current or previous use of insulin-increasing medications or exogenous insulin
  • Prescribed drugs that may interact with the supplements
  • Medical conditions or allergies that interfere with supplement use, including pregnancy, breastfeeding, certain gastrointestinal diseases, kidney or liver conditions, HIV, and multiple specific allergies
  • Currently following specific diets such as FODMAP, keto, or paleo
  • Gastrointestinal diseases including esophagitis, celiac disease, malignancies, peptic or gastric ulcers, except appendectomy and benign polypectomy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Viome Life Sciences

Bothell, Washington, United States, 98011

Actively Recruiting

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Research Team

M

Mory Mehrtash

CONTACT

M

Momchilo Vuyisich

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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