Viome Nutritional Programs to Improve Clinical Outcomes for Metabolic Conditions

Description

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

Metabolic Health

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Study Overview

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Study Details

Study overview

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.

Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Metabolic Conditions

Viome Nutritional Programs to Improve Clinical Outcomes for Metabolic Conditions

Condition
Metabolic Health
Intervention / Treatment

-

Contacts and Locations

Bothell

Viome Life Sciences, Bothell, Washington, United States, 98011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Resident of the United States
  • * Females and males ages 25-75 (inclusive)
  • * Able to speak and read English
  • * No unexplained weight loss, fevers, anemia, or blood in stool
  • * Willing and able to follow the trial instructions, as described in the recruitment letter
  • * Signed and dated informed consent prior to any trial-specific procedures.
  • * Fasting insulin level \>=15 uIU/mL or fasting glucose \>= 100 mg/dL within the last 3 months, verified from medical records
  • * Unwilling to change current diet
  • * Unwilling to go to Quest
  • * Prior use of Viome products or services
  • * Antibiotic use in the previous 4 weeks
  • * Women who are pregnant (current or planned in the next 4 months), or breastfeeding
  • * \< 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 1 month
  • * IBD diagnosis
  • * Use of investigational drugs, products or devices within 1 month prior to and 4 months after the start of the trial
  • * Cancer therapy within the previous 1 year
  • * Major surgery in the last 6 months or planned in the next 4 months
  • * 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.)
  • * Prescribed any drug(s) that may interact with the supplement formulations
  • * Have any medical condition or allergy that may interact with, or prevents the healthy consumption of the supplements such as:
  • * Allergies to any study-specific supplement ingredients
  • * Currently on a specific diet:
  • * Gastrointestinal disease including:
  • * GI surgery except:
  • * Appendectomy and benign polypectomy
  • * Esophagitis
  • * Celiac disease
  • * GI malignancy or obstruction
  • * Peptic Ulcer Disease
  • * Duodenal or gastric ulcer disease

Ages Eligible for Study

25 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Viome,

Momchilo Vuyisich, PRINCIPAL_INVESTIGATOR, Viome Life Sciences

Study Record Dates

2024-12