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RECRUITING

NCT05564273

Viome Nutritional Programs to Improve Clinical Outcomes for Metabolic Conditions

Sponsor: Viome

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

25 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2023-10-13

Completion Date

2026-12

Last Updated

2025-01-29

Healthy Volunteers

Conditions

Metabolic Health

Interventions

COMBINATION_PRODUCT

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.

DIETARY_SUPPLEMENT

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.

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

Locations (1)

Viome Life Sciences

Bothell, Washington, United States