[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557961":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":59,"collaborators":30,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":30,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":30,"overallStatus":43,"whyStopped":30,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Skidmore College","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Synbiotic","EXPERIMENTAL","synbiotic (Triplex (2x\u002Fday Probiotic capsules (2 billion CFU\u002Fcapsule, ProBio5), 2x\u002Fday Capsules of gut supporting micronutrients; magnesium, vitamin c and citrus bioflavonoids (BioCleanse) and 2x\u002Fday Pre-biotic drink mixes (Slim Microbiome Activating), Plexus®, Scottsdale, AZ, USA)",[13],"Dietary Supplement: Synbiotic, Probiotic, Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Probiotic","ACTIVE_COMPARATOR","probiotic (2x\u002Fday probiotic capsules (2 billion CFU\u002Fcapsules, NOW supplement), 2x\u002Fday capsules of collagen (Plexus), and 2x\u002Fday placebo drink mixes of corn-based maltodextrin (Plexus))",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo","PLACEBO_COMPARATOR","placebo control (4x\u002Fday collagen capsules and 2x\u002Fday placebo drink mixes (maltodextrin), Plexus)",[13],[25],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DIETARY_SUPPLEMENT","Synbiotic, Probiotic, Placebo","Use of dietary supplements to improve gut microbiome and cardiometabolic health",[20,15,9],null,[32],{"name":33,"affiliation":5,"role":34},"Stephen J Ives, PhD","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":30,"email":40},"Steve Ives, PhD","CONTACT","5185808366","sives@skidmore.edu",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Saratoga Springs","New York","12866","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-73.78457,43.08313,{"lat":53,"lon":52},[56],{"name":57,"role":38,"phone":58,"phoneExt":30,"email":40},"Stephen Ives, Ph.D.","518-580-8366",{"type":34,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Stephen J. Ives","Associate Professor","100557961","evaluating-the-effects-of-a-synbiotic-versus-probiotic-or-placebo-on-gut-microbiota-and-cardiometabolic-health-a-randomized-double-blind-placebo-controlled-trial-100557961",false,"NCT06544915","Evaluating the Effects of a Synbiotic Versus Probiotic or Placebo on Gut Microbiota and Cardiometabolic Health: A Randomized Double-Blind Placebo Controlled Trial","GUTRCT","Inclusion Criteria:\n\n* To be included participants must be healthy, weight stable (± 4.4 lb for \\> 6 months prior), and 18 to 60 years of age. Participants will be expected to be relatively healthy without uncontrolled chronic disease (e.g. cardiovascular, metabolic, or pulmonary) and 1 or fewer positive risk factors for cardiovascular disease (e.g. high blood pressure, high cholesterol, etc.) as described by the American College of Sports Medicine\u002FAmerican Heart Association Criteria and presented in the table 1 below. Per College policy, participants who are visitors are required to be fully vaccinated against COVID-19, including a booster, and participants who are faculty, staff or students are required to be fully vaccinated against COVID-19 and receive a booster by January 24, 2022 or within 30 days of becoming eligible, unless a medical or religious exemption has been granted. Participants will be screened for eligibility by health history form in person baseline measurements are made (Figure 1). To ensure greater inclusion, ecological validity and representation, women will be included in this study; however, we will not control for menstrual cycle phase, but will document for possible statistical consideration.\n\nExclusion Criteria:\n\n* Given the focus of the study those who are currently, or have recently used (\\\u003C3 months), oral antibiotics or have diagnosed irritable bowel syndrome or gut\u002Fbowel maladies (short bowel syndrome, etc.) will be excluded. Subjects who present with 2 or more CVD risk factors (table above) or have uncontrolled\u002Fovert cardiovascular, pulmonary, or metabolic disease (Diabetes Mellitus), or recent blood donation (\\\u003C8 weeks) will be excluded. Those who have cancer or are being treated for cancer will also be excluded. Women who are currently pregnant, breastfeeding, attempting to conceive, or amenorrheic (not associated with menopause or use of contraceptive medications) will also be excluded from the study. Anyone who is being treated for hypothyroid with levothyroxine will be excluded as one of the supplement ingredients, chromium polynicotinate, may interfere with this medication . Anyone with severe illness or compromised or suppressed immune system (e.g. taking immune suppressants, chronic viral infection or treatment) will be excluded. Anyone recently diagnosed (\\\u003C1yr) with an eating disorder or food allergies will also be excluded.",true,"ALL","18 Years","60 Years",{"count":74,"type":75},60,"ESTIMATED","INTERVENTIONAL",[78],"NA","Accordingly, the purpose of this study is to evaluate the efficacy of 1) supplementation with Synbiotic (Plexus® Triplex), 2) commercially-available Probiotic, or 3) placebo control over 30 days on the gut microbiome, cardiometabolic health, body weight and body composition in healthy individuals.",[81],"Blood Pressure, Body Composition, Immune Function","2024-08-06",{"date":84,"type":85},"2024-08-09","ACTUAL",{"date":87,"type":85},"2024-07-23",{"date":89,"type":75},"2025-01-01",{"name":5,"class":6},1]