[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609883":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":39,"locations":48,"responsibleParty":66,"collaborators":25,"id":69,"slug":25,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":25,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":25,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":51,"whyStopped":25,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Tufts University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Plant-based meat alternative entree","EXPERIMENTAL","Entree that is composed of a plant-based meat alternative",[13,14],"Other: plant-based meat alternative entrees","Device: mini-pill",{"label":16,"type":10,"description":17,"interventionNames":18},"meat entree","entree that is composed of meat",[14,19],"Other: meat based entree",[21,26,31],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"plant-based meat alternative entrees","2 plant-based meat alternatives per day",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DEVICE","mini-pill","mini-pills which sample at different locations in the gut",[9,16],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":25},"meat based entree","2 meat based entrees per day",[16],[36],{"name":37,"affiliation":5,"role":38},"Alice H Lichtenstein, D.Sc.","PRINCIPAL_INVESTIGATOR",[40,44],{"name":37,"role":41,"phone":42,"phoneExt":25,"email":43},"CONTACT","617 556-3127","alice.lichtenstein@tufts.edu",{"name":45,"role":41,"phone":46,"phoneExt":25,"email":47},"Jean Galluccio, BS","617 556-3121","jean.galluccio@tufts.edu",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Jean Mayer Human Nutrition Research Center on Aging","RECRUITING","Boston","Massachusetts","02111","United States",{"type":57,"coordinates":58},"Point",[59,60],-71.05977,42.35843,{"lat":60,"lon":59},[63],{"name":64,"role":41,"phone":65,"phoneExt":25,"email":25},"Volunteer Services","800-738-7555",{"type":38,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Alice Lichtenstein","Director of Cardiovascular Research Team","100609883",false,"NCT07220369","Gut Mini-Pill Study","Evaluation of Ingestible Mini-pill for Gastrointestinal Regional Luminal Content Sampling","Inclusion Criteria:\n\n* Men and postmenopausal women\n* Age \\>50 to \\\u003C75 years\n* BMI \\>20 to \\\u003C35 kg\u002Fm2\n* Normotensive with or without medication\n* Normal gastrointestinal function with regular bowel movements at least once every other day\n* Normal kidney and liver function\n* Willingness to swallow the mini-pills\n* Willingness to collect and return multiple stool samples\n* Adequate refrigerator and freezer space to store study entrées\n* Intent to remain in the greater Boston area during the intervention periods\n\nExclusion Criteria:\n\n* Individuals self-reporting adhering to any type of vegetarian diet\n* Lack of willingness to restrict fish intake to less than once per week during the dietary intervention phases\n* Allergy\u002Fintolerance\u002Freligious reasons to avoid study foods or food ingredients, including known hypersensitivity to Blue 1 food coloring and wheat gluten.\n* Regular use of prebiotics or probiotics within the past 3 months\n* Regular use of laxatives or fiber supplements\n* Chronic constipation\n* Chronic use of antibiotics (except topical)\n* Regular use of stomach acid lowering and weight loss medications such as GLP-1 agonists\n* Use of dental prophylaxis\n* Planned colonoscopy 2 months prior to or during the study period\n* Gastroparesis\n* Swallowing disorder, or inability or difficulty taking pills\n* Malabsorptive and inflammatory bowel disease, diverticulosis, and history of diverticulitis, gastric\u002F esophageal\u002Fintestinal surgery, including lap banding or bariatric surgery.\n* History of bowel obstruction, pancreas and liver disorders.\n* Any form of active substance abuse or dependence (including drug or alcohol abuse). This information will be stored in REDCAP in a subsection that has no identifiers.\n* Established major chronic diseases such as cardiovascular disease, diabetes, active cancer within the last 5 years, or any significant medical condition at the study MD's discretion\n* A clinical condition that, in the judgment of the study MD or principal investigator, could potentially pose a health risk to the subject while involved in the study.\n* Unwillingness to adhere to study protocol\n* Intent to increase or decrease body weight during the study period\n* No Social Security number (for payment and IRS forms).\n* Individuals who directly report to any member of the research team.",true,"ALL","50 Years","75 Years",{"count":80,"type":81},30,"ESTIMATED","INTERVENTIONAL",[84],"NA","The purpose of this proof-of-concept study in humans is to determine if a noninvasive, ingestible device, called a \"mini-pill\", can collect gastrointestinal (GI) luminal content samples from 2 different locations along the GI tract after consumption of diets differing in protein source (meat and plant-based meat alternatives). The mini-pills will be recovered in the stool. We will analyze the microbial profile of the mini-pill contents and in stool, and also measure blood biomarkers related to cardiometabolic risk, to better understand the relationship between diet, microbiota and health.",[87],"Gut Microbiota",[89,28,90,91],"gut","gut sampling","gut microbiota","2025-10-28",{"date":94,"type":95},"2025-10-30","ACTUAL",{"date":97,"type":95},"2025-09-08",{"date":99,"type":81},"2028-08",{"name":5,"class":6},1]