[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100482610":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":44,"locations":51,"responsibleParty":70,"collaborators":12,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":12,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":12,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":53,"whyStopped":12,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Viome","INDUSTRY",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","NO_INTERVENTION","Participants may be provided with any combination of nutritional recommendations and they receive placebo supplements. Placebo capsules will contain inert and inactive materials. The participants are asked to take the supplements on a daily basis.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Viome's Precision Nutrition Program","ACTIVE_COMPARATOR","Participants may be provided with any combination of nutritional recommendations and supplements. The participants are asked to take the supplements on a daily basis.",[18],"Combination Product: VIOME Precision Nutrition Program",{"label":20,"type":15,"description":21,"interventionNames":22},"Viome's condition-based supplements","Participants may be provided with any combination of nutritional recommendations and they receive condition based supplements. The participants are asked to take the supplements on a daily basis.",[23],"Dietary Supplement: VIOME-designed condition-based supplements",[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"COMBINATION_PRODUCT","VIOME Precision Nutrition Program","Precision supplement based on the participants microbiome sample results. Participants in this arm may receive supplements, diet recommendations, and app coaching.",[14],[31],"VPNP",{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DIETARY_SUPPLEMENT","VIOME-designed condition-based supplements","Pre-formulated supplements based on overall health conditions. Participants in this arm may receive supplements, diet recommendations, and app coaching.",[20],[38],"VCS",[40],{"name":41,"affiliation":42,"role":43},"Momchilo Vuyisich","Viome Life Sciences","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":12,"email":49},"Mory Mehrtash","CONTACT","(425) 300-6933","studies@viome.com",{"name":41,"role":47,"phone":48,"phoneExt":12,"email":49},[52],{"facility":42,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Bothell","Washington","98011","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-122.2054,47.76232,{"lat":63,"lon":62},[66,67,68],{"name":41,"role":47,"phone":48,"phoneExt":12,"email":49},{"name":46,"role":47,"phone":48,"phoneExt":12,"email":49},{"name":69,"role":43,"phone":12,"phoneExt":12,"email":12},"Momchilo Vuyisich, PhD",{"type":71,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100482610","viome-nutritional-programs-to-improve-clinical-outcomes-for-metabolic-conditions-100482610",false,"NCT05564273","Viome Nutritional Programs to Improve Clinical Outcomes for Metabolic Conditions","Testing the Efficacy of Viome-designed Condition-based Supplements and Viome Precision Supplements to Improve Clinical Outcomes for Metabolic Conditions","Inclusion Criteria:\n\n* Resident of the United States\n* Females and males ages 25-75 (inclusive)\n* Able to speak and read English\n* No unexplained weight loss, fevers, anemia, or blood in stool\n* Willing and able to follow the trial instructions, as described in the recruitment letter\n* Signed and dated informed consent prior to any trial-specific procedures.\n* Fasting insulin level \\>=15 uIU\u002FmL or fasting glucose \\>= 100 mg\u002FdL within the last 3 months, verified from medical records\n\nExclusion Criteria:\n\n* Unwilling to change current diet\n* Unwilling to go to Quest\n* Prior use of Viome products or services\n* Antibiotic use in the previous 4 weeks\n* Women who are pregnant (current or planned in the next 4 months), or breastfeeding\n* \\\u003C 90 days postpartum\n* Active infection\n* Unable or unwilling to use Viome's App on an iPhone or Android smartphone\n* Significant diet or lifestyle changes in the previous 1 month\n* IBD diagnosis\n* Use of investigational drugs, products or devices within 1 month prior to and 4 months after the start of the trial\n* Cancer therapy within the previous 1 year\n* Major surgery in the last 6 months or planned in the next 4 months\n* Current (or previous) use of medications that increase insulin (sulfonylureas, such as glimepiride, glipizide, glyburide, etc.)\n* Current (or previous) use of exogenous insulin (such as Tresiba, Lantus, Toujeo, Levemir, Humalog, Novolog, Apidra, Fiasp, etc.)\n* Prescribed any drug(s) that may interact with the supplement formulations\n* Have any medical condition or allergy that may interact with, or prevents the healthy consumption of the supplements such as:\n\nPregnancy 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\u002FNASH, etc) HIV SIBO CuminAllergy GymnemaAllergy BacopaAllergy CitrusAIlergy LamiaceaeAllergy SageAllergy YeastAllergy MulberryAllergy ChicoryAllergy\n\n* Allergies to any study-specific supplement ingredients\n* Currently on a specific diet:\n\nFODMAP KETO PALEO\n\n* Gastrointestinal disease including:\n\n  * GI surgery except:\n\n    * Appendectomy and benign polypectomy\n* Esophagitis\n* Celiac disease\n* GI malignancy or obstruction\n* Peptic Ulcer Disease\n* Duodenal or gastric ulcer disease","ALL","25 Years","75 Years",{"count":83,"type":84},150,"ESTIMATED","INTERVENTIONAL",[87],"NA","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.",[90],"Metabolic Health",[92,93,94,95,96,97,98,99,100,101],"BMI","Framingham Risk Score","Insulin","blood glucose","HbA1c","hsCRP","Lipids","Supplements","Vitamins","diet","2025-01-27",{"date":104,"type":105},"2025-01-29","ACTUAL",{"date":107,"type":105},"2023-10-13",{"date":109,"type":84},"2026-12",{"name":5,"class":6},1]