[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558046":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":37,"centralContacts":41,"locations":50,"responsibleParty":70,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":32,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":99,"overallStatus":52,"whyStopped":32,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Montana State University","OTHER",[8,14,20,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo, Metabolically Healthy","PLACEBO_COMPARATOR","The placebo supplement will have no polyphenol content and will be carbohydrate-matched to the experimental group. A twice daily dose (10-12 hours apart) will be consumed for 8 weeks.",[13],"Dietary Supplement: Placebo comparator",{"label":15,"type":16,"description":17,"interventionNames":18},"Haskap, Metabolically Healthy","EXPERIMENTAL","The haskap supplement will consist of a haskap berry smoothie. A twice daily dose (10-12) hours apart will be consumed for 8 weeks.",[19],"Dietary Supplement: Haskap berry smoothie",{"label":21,"type":10,"description":11,"interventionNames":22},"Placebo, Metabolically Unhealthy",[13],{"label":24,"type":16,"description":17,"interventionNames":25},"Haskap, Metabolically Unhealthy",[19],[27,33],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIETARY_SUPPLEMENT","Haskap berry smoothie","A smoothie blend of berries and water",[15,24],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Placebo comparator","A smoothie with no polyphenolic content and matched in carbohydrate composition to the experimental haskap smoothie",[9,21],[38],{"name":39,"affiliation":5,"role":40},"Mary P Miles, PhD","PRINCIPAL_INVESTIGATOR",[42,46],{"name":39,"role":43,"phone":44,"phoneExt":32,"email":45},"CONTACT","406-994-6678","mmiles@montana.edu",{"name":47,"role":43,"phone":48,"phoneExt":32,"email":49},"Zachary T Miller, PhD","(406) 961-3025","zachariah.miller@montana.edu",[51],{"facility":5,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Bozeman","Montana","59717","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-111.03856,45.67965,{"lat":62,"lon":61},[65,66],{"name":39,"role":43,"phone":44,"phoneExt":32,"email":45},{"name":67,"role":43,"phone":68,"phoneExt":32,"email":69},"Brian Bothner, PhD","1-406-994-5270","bbothner@montana.edu",{"type":71,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[73],{"name":74,"class":75},"Montana State Agricultural Experiment Station","UNKNOWN","100558046","gut-microbiota-dependent-health-impacts-of-haskap-berries-100558046",false,"NCT06546020","Gut Microbiota-dependent Health Impacts of Haskap Berries","PARTNERSHIP: Elucidating Gut Microbiota-dependent Health Impacts of Haskap Berries to Inform Agricultural Production Practices That Will Maximize Bioactive Potential","HIH","Inclusion Criteria for Metabolically Healthy Group:\n\nAll of the following:\n\n* Waist circumference: men ≤ 40, women ≤ 35 inches\n* Systolic blood pressure: ≤ 130 mmHg\n* Diastolic blood pressure: ≤ 85 mmHg\n* Fasting glucose: ≤ 100 mg·dl-1\n* Fasting triglycerides: ≤ 150 mg·dl-1\n* HDL: men \\> 40, women \\> 50 mg·dl-1\n\nInclusion Criteria for Metabolically Unhealthy Group:\n\nRequired:\n\n\\- Waist circumference: men ≥ 40, women ≥ 35 inches\n\nAND ≥ 1 of the following:\n\n* Systolic blood pressure: \\> 130 mmHg\n* Diastolic blood pressure: \\> 85 mmHg\n* Fasting glucose: \\> 100 mg·dl-1\n* Fasting triglycerides: \\> 150 mg·dl-1\n* HDL: men ≤ 40, women ≤ 50 mg·dl-1\n\nExclusion Criteria:\n\n* BMI \\\u003C18 or \\> 40 kg\u002Fm\\^2\n* potential allergy to Haskap or placebo ingredients\n* use of anti-inflammatory, lipid lowering, glucose lowering, blood pressure, or any other medications that may interfere with study measures\n* pregnant or lactating woman\n* diagnosis with type 1 or type 2 diabetes or any other condition that may interfere with study measures\n* smoke cigarettes\n* have taken antibiotics in the past 90 days\n* take supplements including pre\u002Fprobiotics or \"superfoods\" within 30 days of starting the study\n* are planning on starting a weight loss or exercise regiment change\n* follow a specific diet such as low carbohydrate, vegan, and vegetarian\n* consume over 5 servings of fruit\u002Fvegetables per day\n* are unwilling to reduce caffeine intake to one 8 oz serving per day for the durations of the study",true,"ALL","35 Years","65 Years",{"count":89,"type":90},120,"ESTIMATED","INTERVENTIONAL",[93],"NA","Polyphenol-rich Haskap berries (Haskap) have untapped therapeutic potential to improve human health, and agricultural producers in northern U.S. states are poised to increase production if consumer demand increases. A critical knowledge gap is that little is known about the interactions between gut microbes and Haskap polyphenols to produce bioactive metabolites linked to downstream health impacts. Additionally, little is known about which Haskap varieties and harvest timing yield the greatest bioactive potential. This study aims to address these gaps by investigating the interaction of bioactive components in Haskap with gut microbiota and the resultant gut and serum metabolites, inflammation, and metabolic health, and then couple this with analysis of berries from different Haskap varieties and harvest times.",[96,97,98],"Metabolic Disease","Inflammation","Microbial Colonization",[100,101,102,103],"Microbial metabolism","Gut microbial composition","Serum metabolome","Polyphenols","2025-04-01",{"date":106,"type":107},"2025-04-02","ACTUAL",{"date":109,"type":107},"2025-02-26",{"date":111,"type":90},"2028-05",{"name":5,"class":6},1]