[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475031":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":35,"responsibleParty":57,"collaborators":12,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":12,"eligibilityCriteria":64,"healthyVolunteers":61,"sex":65,"minAge":66,"maxAge":12,"enrollmentInfo":67,"targetDuration":12,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":38,"whyStopped":12,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Viome","INDUSTRY",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","NO_INTERVENTION","Participants with HbA1c levels between 5.7-8.9% (inclusive) are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Placebo capsules will contain inert and inactive materials. Participants may need to use a mobile app in order to participate in the trial.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Viome's Precision Nutrition Program (VPNP)","EXPERIMENTAL","Participants with HbA1c levels between 5.7-8.9% (inclusive) are randomized into this arm. They may be provided with any combination of nutritional recommendations and supplements. Participants may need to use a mobile app in order to participate in the trial.",[18],"Dietary Supplement: Viome's Precision Nutrition Program (VPNP)",[20],{"type":21,"name":14,"description":22,"armGroupLabels":23,"otherNames":12},"DIETARY_SUPPLEMENT","Nutrition, diet, and possible coaching through Viome application. Precision supplement based on the participants microbiome sample results.",[14],[25],{"name":26,"affiliation":5,"role":27},"Momchilo Vuyisich","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":12,"email":33},"Mory Mehrtash","CONTACT","(425) 300-6933","studies@viome.com",{"name":26,"role":31,"phone":32,"phoneExt":12,"email":33},[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Viome Life Sciences","RECRUITING","Bothell","Washington","98011","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-122.2054,47.76232,{"lat":48,"lon":47},[51,54,56],{"name":52,"role":31,"phone":53,"phoneExt":12,"email":33},"Momchilo Vuyisich, PhD","425-300-6933",{"name":55,"role":31,"phone":32,"phoneExt":12,"email":33},"Mory Mehrtash, MSc",{"name":52,"role":27,"phone":12,"phoneExt":12,"email":12},{"type":58,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100475031","efficacy-of-viomes-precision-nutrition-program-towards-reducing-hba1c-100475031",false,"NCT05465616","Efficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c","Inclusion Criteria:\n\n* Signed and dated informed consent form and medical release prior to any trial-specific procedures are performed\n* Females and males aged 18 years or older\n* Able to speak and read English\n* HbA1c between 5.7-8.9% (inclusive), tested within the past 30 days\n* Willing and able to visit a Quest Diagnostic Patient Service Center (PSC)\n* Willing and able to follow the trial instructions and Viome's Precision Nutrition Program\n* Willing and able to use a smartphone and Viome app.\n\nExclusion Criteria:\n\n* Antibiotic use within one month of the GI test\n* Gestation within previous 6 month\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* On a specific diet, such as ketogenic, for the purpose of reducing HbA1c and\u002For weight within the previous month\n* Taking diet pills\n* Allergy to an ingredient in the MH capsule or stick pack\n* Currently on an investigational product\n* Significant surgery or medical procedure planned\n* Diet or lifestyle change during the trial period, besides those appropriate for trial arm Has followed Viome nutritional recommendations (foods and\u002For supplements)","ALL","18 Years",{"count":68,"type":69},150,"ESTIMATED","INTERVENTIONAL",[72],"NA","This is a randomized, placebo-controlled trial that will test the efficacy of VPNP in reducing HbA1c. Participant recruitment will occur through direct-to-participant enrollment. No additional clinical sites will be used for recruitment.",[75,76],"Diabetes","Pre Diabetes",[78,79,80,81,82,83,84,85,86],"Health","Wellness","Nutrition","Vitamins","Supplements","Prebiotics","Probiotics","Fitness","Blood sugar","2025-01-21",{"date":89,"type":90},"2025-01-24","ACTUAL",{"date":92,"type":90},"2022-08-22",{"date":94,"type":69},"2026-12-13",{"name":5,"class":6},1]