[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02573753":3,"trial-entities:NCT02573753":89,"trial-summary:NCT02573753":93},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":38,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":16,"healthy_volunteers":48,"eligibility_criteria":49,"std_ages":56,"locations":59,"central_contacts":82,"overall_officials":85,"references":87,"see_also_links":88},"NCT02573753","15-002092","The Effects of Sleep on Human Microbiota: Implications for Health and Disease","RECRUITING","2031-12","2026-07","2026-08-04","2015-10","Mayo Clinic","OTHER",false,"The aggregate of microorganisms inhabiting the human body can be regarded as a dynamic reflector of both healthy and disease states, altering in response to changes in the environment. This may precede clinically detectable disease; and thereby, could be used to predict disease onset and additionally monitor response to treatment and predict prognosis. The primary hypothesis of this pilot study is that the human microbial communities are influenced by sleep and altered in humans with abnormal sleep patterns, and they may ultimately relate to disease risk.",null,[18],"Sleep",[],"INTERVENTIONAL","PREVENTION",[23],"NA",{"count":25,"type":26},5000,"ESTIMATED",[28,33],{"type":29,"name":30,"armGroupLabels":31},"BEHAVIORAL","Sleep restriction",[32],"sleep restriction",{"type":34,"name":35,"armGroupLabels":36},"DIETARY_SUPPLEMENT","Weight gain",[37],"weight gain",[39,42],{"measure":40,"timeFrame":41},"Changes in human microbiota induced by sleep manipulation in healthy subjects","1 year",{"measure":43,"timeFrame":44},"Changes in human microbiota induced by fluctuations in body weight and sleep in healthy subjects","20 weeks",[],"ALL","18 Years",true,{"inclusion":50,"exclusion":52,"raw_text":55},[51],"Only subjects who are eligible for ongoing IRB-approved studies will be deemed eligible for this protocol.",[53,54],"Pregnant or breast-feeding women","Subjects who are ineligible for ongoing IRB-approved studies will not be included in this protocol","Inclusion Criteria:\n\n* Only subjects who are eligible for ongoing IRB-approved studies will be deemed eligible for this protocol.\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women\n* Subjects who are ineligible for ongoing IRB-approved studies will not be included in this protocol",[57,58],"ADULT","OLDER_ADULT",[60],{"facility":61,"status":7,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":79},"Mayo Clinic Rochester","Rochester","Minnesota","55905","United States",[67,72,76],{"name":68,"role":69,"phone":70,"email":71},"Nick Wozniak","CONTACT","507-255-8794","Wozniak.Nicholas@mayo.edu",{"name":73,"role":69,"phone":74,"email":75},"Laura Hammel","507-255-6676","Hammel.Laura@mayo.edu",{"name":77,"role":78},"Virend Somers, MD, PhD","PRINCIPAL_INVESTIGATOR",{"lat":80,"lon":81},44.02163,-92.4699,[83,84],{"name":68,"role":69,"phone":70,"email":71},{"name":73,"role":69,"phone":74,"email":75},[86],{"name":77,"affiliation":12,"role":78},[],[],{"nct_id":4,"conditions":90,"biomarkers":92},[91],"Sleep Disorder",[],{"nct_id":4,"found":48,"summary":94,"prompt_version":104},{"design":95,"status":96,"heading":97,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This is an interventional study with a planned enrollment of 5000 participants. It is not specified if it is randomized or blinded.","completed","The Effects of Sleep on Human Microbiota","This study is looking at how sleep affects the human microbiota (the community of tiny living things in and on your body). Researchers believe that changes in your microbiota might show up before you get sick, and could help predict when a disease might start or how well a treatment is working. This study will explore if your microbiota is changed by sleep restriction (getting less sleep) and weight gain. They want to see if these changes in microbiota are linked to health risks. The study aims to enroll 5000 healthy adults, aged 18 and older, who are already eligible for other approved studies. The goal is to see how your microbiota changes after one year due to sleep changes, and after 20 weeks due to changes in body weight and sleep.","Participants will be followed for changes in microbiota for up to one year, and for 20 weeks regarding changes related to body weight and sleep.",132,"Not specified in the trial record.","Not stated in the trial record.",[30,35],"v2"]