RECRUITING
I'm interested ...!!
Viome Nutritional Programs to Improve Clinical Outcomes for Metabolic Conditions
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
🗓️ Study Start (Actual) 13 October 2023
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) December 2024
👥 Enrollment (Estimated) 150
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Bothell, Washington, United States

📋 Eligibility Criteria

Description

    Inclusion 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

    Exclusion Criteria:

    • * 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:
    • Pregnancy Breastfeeding Minors GERD Gastric Ulcers Ulcerative Colitis Crohn's Disease Kidney Impairment (kidney cysts, kidney disease) Liver Condition (gallstones, cholecystitis, cirrhosis, hepatitis, hepatitis a, hepatitis b, hepatitis c, NAFLD/NASH, etc) HIV SIBO CuminAllergy GymnemaAllergy BacopaAllergy CitrusAIlergy LamiaceaeAllergy SageAllergy YeastAllergy MulberryAllergy ChicoryAllergy
    • * Allergies to any study-specific supplement ingredients
    • * Currently on a specific diet:
    • FODMAP KETO PALEO
    • * 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 (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 28 September 2022
  • First Submitted that Met QC Criteria 28 September 2022
  • First Posted 3 October 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 December 2023
  • Last Update Posted 20 December 2023
  • Last Verified December 2023
I'm interested ...!!