Metabolic Health Clinical Trial
Official title:
Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Metabolic Conditions
NCT number | NCT05564273 |
Other study ID # | V211.2 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 13, 2023 |
Est. completion date | December 2024 |
Verified date | December 2023 |
Source | Viome |
Contact | Mory Mehrtash |
Phone | (425) 300-6933 |
studies[@]viome.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Viome Life Sciences | Bothell | Washington |
Lead Sponsor | Collaborator |
---|---|
Viome |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of VIOME's designed condition based supplements (VCS) | Number of participants that show an improvement in metabolic health compared to baseline survey assessment. | ~4months | |
Primary | Efficacy of VIOME Precision Nutrition Program (VPNP) | Number of participants that show an improvement in metabolic health compared to baseline survey assessment. | ~4 months |
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