Viome Nutritional Programs to Improve Clinical Outcomes for Metabolic Conditions
Viome · NCT05564273
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 25–75 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 150
- US sites recruiting
- 1
- Study start
- October 13, 2023
- Record last updated
- January 29, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: VIOME Precision Nutrition Program; VIOME-designed condition-based supplements
Conditions: Metabolic Health
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Viome Life Sciences
Bothell, WA 98011
Site contact: Momchilo Vuyisich · (425) 300-6933 · studies@viome.com
Study contacts (from the official record)
- Mory Mehrtash · (425) 300-6933 · studies@viome.com
- Momchilo Vuyisich · (425) 300-6933 · studies@viome.com
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