Viome Nutritional Programs to Improve Clinical Outcomes for Metabolic Conditions
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Metabolic Health
In brief
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.
Key facts
- Study ID
- NCT05564273
- Run by
- Viome
- People needed
- 150
- Starts
- 2023-10-13
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-01-29
Who can join
Age: 25 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Viome Life Sciences — Bothell, Washington, United States (enrolling)
Full record on ClinicalTrials.gov
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