Clinical trial NCT05564273: Viome Nutritional Programs to Improve Clinical Outcomes for Metabolic Conditions
Official title: Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Metabolic Conditions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Health
Keywords: BMI
Framingham Risk Score
Insulin
blood glucose
HbA1c
hsCRP
Lipids
Supplements
Vitamins
diet
Lead sponsor: Viome
Sponsor class: INDUSTRY
First posted: 2022-10-03
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, blinded, cohort study divided into three arms: 1) control group (placebo), 2) condition-based supplement, 3) precision-supplement
Primary purpose: TREATMENT

Brief 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.

Detailed description: Participants who meet the eligibility criteria are randomized into any of the three arms including: the placebo arm, VIOME's condition-based supplements (VCS) arm or the VIOME Precision Nutrition Program (VPNP) arm.

Placebo, Viome-designed condition-based supplements and Viome's Precision Nutrition Program include supplements and/or dietary recommendations towards improving the symptoms associated with metabolic wellness. The trial will last approximately 4 months for each participant.

Eligibility criteria: 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 outcomes:
measure: Efficacy of VIOME's designed condition based supplements (VCS)
timeFrame: ~4months
measure: Efficacy of VIOME Precision Nutrition Program (VPNP)
timeFrame: ~4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bothell
country: United States
facility: Viome Life Sciences
state: Washington
Study officials:
affiliation: Viome Life Sciences
name: Momchilo Vuyisich
role: PRINCIPAL_INVESTIGATOR
References: