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Recruiting Not applicable

Viome Nutritional Programs to Improve Clinical Outcomes for Metabolic Conditions

NCT05564273 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Not applicable
Started
2023-10-13
Last updated
2025-01-29

Condition(s) studied

Metabolic Health

Investigational drug(s) / intervention(s)

VIOME Precision Nutrition ProgramVIOME-designed condition-based supplements

VIOME Precision Nutrition Program: 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: Pre-formulated supplements based on overall health conditions. Participants in this arm may receive supplements, diet recommendations, and app coaching.

Study summary

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.

Eligibility

Sex
ALL
Min age
25 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Efficacy of VIOME's designed condition based supplements (VCS) — ~4months
    Number of participants that show an improvement in metabolic health compared to baseline survey assessment.
  • Efficacy of VIOME Precision Nutrition Program (VPNP) — ~4 months
    Number of participants that show an improvement in metabolic health compared to baseline survey assessment.

Trial sites (1)

FacilityCityRegionStatus
Viome Life Sciences Bothell Washington Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05564273 on ClinicalTrials.gov ↗ ← All trials in the USA