[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530316":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":35,"responsibleParty":56,"collaborators":12,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":12,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":65,"maxAge":12,"enrollmentInfo":66,"targetDuration":12,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":38,"whyStopped":12,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Viome","INDUSTRY",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","NO_INTERVENTION","Participants with HbA1c levels between 6.5-8.9% (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 6.5-8.9% (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},[51,53,55],{"name":52,"role":31,"phone":32,"phoneExt":12,"email":33},"Momchilo Vuyisich, PhD",{"name":54,"role":31,"phone":32,"phoneExt":12,"email":33},"Mory Mehrtash, MSc",{"name":52,"role":27,"phone":12,"phoneExt":12,"email":12},{"type":57,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100530316","efficacy-of-viomes-precision-nutrition-program-towards-reducing-hba1c-100530316",false,"NCT06185192","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 6.5-8.9% (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":67,"type":68},100,"ESTIMATED","INTERVENTIONAL",[71],"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.",[74],"Diabetes",[76,77,78,79,80,81,74,82],"Health","Wellness","Nutrition","Vitamins","Supplements","Blood sugar","Fitness","2025-01-27",{"date":85,"type":86},"2025-01-29","ACTUAL",{"date":88,"type":86},"2023-12-13",{"date":90,"type":68},"2026-12",{"name":5,"class":6},1]