[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520035":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":63,"locations":68,"responsibleParty":88,"collaborators":24,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":24,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":24,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":113,"overallStatus":71,"whyStopped":24,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"BiomeHub Biotechnology Company","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standardized breakfast A","EXPERIMENTAL","Consumption order: Participants will initiate the interventional period by eating the low-carb muffin first following the established muffin order for the next days.",[13],"Other: Standardized breakfast A",{"label":15,"type":10,"description":16,"interventionNames":17},"Standardized breakfast B","Consumption order: Participants will initiate the interventional period by eating the vegan muffin first following the established muffin order for the next days.",[18],"Other: Standardized breakfast B",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"OTHER","Participants will initiate the interventional period by eating the low-carb muffin first following the established muffin order for the next days.",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Participants will initiate the interventional period by eating the vegan muffin first following the established muffin order for the next days.",[15],[29,33,36,39,42,45,48,51,54,56,59],{"name":30,"affiliation":31,"role":32},"Caetana P. Zamparette, PhD","Researcher fellow","STUDY_CHAIR",{"name":34,"affiliation":35,"role":32},"Bianca L. Teixeira, PhD","Clinical research",{"name":37,"affiliation":38,"role":32},"Giuliano Netto, Msc","Bioinformatics development and maintenance",{"name":40,"affiliation":41,"role":32},"Aline FR Sereia, PhD","Chief Operating Officer",{"name":43,"affiliation":44,"role":32},"Ana P. Christoff, PhD","Researcher R&D",{"name":46,"affiliation":47,"role":32},"Daniela C Bastiani, B.Sc","Laboratory manager",{"name":49,"affiliation":50,"role":32},"Fernanda RG Piazza, Msc","Nutricionist",{"name":52,"affiliation":53,"role":32},"Michele P Rode, PhD","Product Owner",{"name":55,"affiliation":44,"role":32},"Milene H Moraes, PhD",{"name":57,"affiliation":58,"role":32},"Natália M Gutierrez","Laboratory analyst",{"name":60,"affiliation":61,"role":62},"Luiz Felipe V. de Oliveira, PhD","BiomeHub CEO","PRINCIPAL_INVESTIGATOR",[64],{"name":60,"role":65,"phone":66,"phoneExt":24,"email":67},"CONTACT","+554830121322","felipe@biome-hub.com",[69],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"BiomeHub","RECRUITING","Florianópolis","Santa Catarina","88054700","Brazil","BR",{"type":78,"coordinates":79},"Point",[80,81],-48.54917,-27.59667,{"lat":81,"lon":80},[84],{"name":85,"role":65,"phone":86,"phoneExt":24,"email":87},"Bianca L Teixeira, PhD","554899183-3662","pesquisa.clinica@biome-hub.com",{"type":89,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100520035","relationship-between-individual-effect-of-diet-on-postprandial-glycemia-and-gut-microbiome-profile-in-healthy-subjects-100520035",false,"NCT06051318","Relationship Between Individual Effect of Diet on Postprandial Glycemia and Gut Microbiome Profile in Healthy Subjects","Individual Effect of Diet on Postprandial Glycemic Response and Its Relationship with Gut Microbiome Profile in Healthy Subjects: Protocol for a Series of Randomized N-of-1 Trials","Inclusion Criteria:\n\n* BMI \\> 18.5 and \\\u003C 30\n* Willing to use an intradermal continuous glucose monitoring sensor during the 10-day study\n* Own a mobile phone with NFC technology\n* Willing to provide a fecal swab sample and a stool sample\n* Understanding, agreement, and signing of the approved Informed Consent Form (ICF) by the Ethics Committee (CEP)\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Diagnosis of any gastrointestinal disorder or disease (Irritable Bowel Syndrome, Ulcerative Colitis, Crohn's Disease)\n* Intolerance or allergy to any diet ingredient\n* Autoimmune disorder (Lupus, Type 1 Diabetes, Celiac Disease) or infectious disease\n* Diabetes diagnosis\n* Cancer diagnosis, acute myocardial infarction, or stroke in the last 6 months\n* Use of hypoglycemic medication\n* Use of proton pump inhibitors, immunosuppressants, or antimicrobials in the last 3 months\n* Use of laxative medications in the last 30 days\n* Underwent invasive procedures or surgery in the last 6 months\n* Admission to ICU in the last 2 years\n* Participation in any experimental study or ingestion of any experimental drug within twelve months prior to the start of this study, in accordance with RDC 251\u002F97\n* Inability to read and understand the informed consent form",true,"ALL","18 Years","60 Years",{"count":102,"type":103},80,"ESTIMATED","INTERVENTIONAL",[106],"NA","When all the food we eat is digested, it will increase blood glucose. Two people can have different glucose blood levels to the same food and one reason can be bacteria live in our gut. There are more than a thousand bacteria species in our gastrointestinal tract that have an important role in the proper functioning of our body, so our gut microbiome is a key piece for our nutrition and blood glucose control.\n\nNowadays, one of the major public health concerns is the rise of people with diabetes (a disease characterized by an increase in blood glucose) and the increase in obesity, in which one of several risks is diabetes. There are multiple reasons for people develop those diseases, however, some care on diet management can prevent, delay, or improve the effects of these illnesses. Therefore, this study proposes studying the blood glucose variation between healthy volunteers and if there is a relationship between that variation and the intestinal bacteria present. These results can help doctors and nutritionists elaborate a personalized diet for people who need blood glucose level control.\n\nThe investigators are recruiting volunteers aged 18 to 60, healthy, living at Florianopolis and the surroundings to participate in this crossover randomized N-of-1 study. The participants must collect fecal samples. After collection, the participants will meet the investigators and receive a kit containing ten standardized breakfasts, with two kinds of muffins, and a kit containing a glucose monitor (Abbott Freestyle Libre-CE marked) to monitor their blood sugar levels. The volunteers must have breakfast with the standardized meals and monitor the fasting glucose blood and postprandial glucose blood levels for ten consecutive days. Besides, they must take notes (like a diet diary) about all the food they ingest during the day in ten days of the study.",[109,110,111,112],"Glucose Metabolism Disorders","Health Behavior","Diabetes","Metabolic Disease",[114,115,116,117,118,119],"Glycemic response","Precision nutrition","Gut Microbiome","Biomarkers","Sequencing analysis","N-of-1 trials","2024-10-22",{"date":122,"type":123},"2024-10-24","ACTUAL",{"date":125,"type":123},"2024-06-06",{"date":127,"type":103},"2025-06-30",{"name":5,"class":6},1]