Nutritional programs to improve metabolic health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study involves U.S. residents with obesity who are randomized into three groups: a placebo group, a group receiving Viome's condition-based supplements, and a group following the Viome Precision Nutrition Program. Participants will complete a survey upon enrollment and will receive dietary recommendations and/or supplements aimed at improving metabolic wellness over a period of approximately four months. The study is designed to assess the effectiveness of these interventions in managing metabolic conditions without utilizing traditional clinical sites.

Why it matters

Who can join: the full rules

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

Where it's running

• Viome Life Sciences
  Bothell, Washington, United States Recruiting

Study contacts

• Principal investigator: Momchilo Vuyisich — Viome Life Sciences
• Study coordinator: Mory Mehrtash
• Email: studies@viome.com
• Phone: (425) 300-6933

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.