[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549136":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":62,"collaborators":64,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":24,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":24,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":47,"whyStopped":24,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Columbia University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Walnut - washout - HCHS","EXPERIMENTAL","Participants will consume 3 servings\u002Fday of walnuts (3 oz\u002Fd) over 4 days and have a washout for 2-3 weeks then crossover to consume 3 equicaloric servings of a HCHS food over 4 days.\n\nOver each 4-day period, participants will sleep and eat at home for the first 3 days and will be admitted to the Inpatient Clinical Research Resource of the Irving Institute for Clinical and Translational Research of CUIMC on day 4 for in-depth profiling circadian physiology. Participants will be discharged on the morning of day 5.",[13,14],"Other: Walnut consumption","Other: HCHS consumption",{"label":16,"type":10,"description":17,"interventionNames":18},"HCHS - washout - Walnut","Participants will consume 3 equicaloric servings of a HCHS food over 4 days and have a washout for 2-3 weeks then crossover to consume 3 servings\u002Fday of walnuts (3 oz\u002Fd) for 4 days.\n\nOver each 4-day period, participants will sleep and eat at home for the first 3 days and will be admitted to the Inpatient Clinical Research Resource of the Irving Institute for Clinical and Translational Research of CUIMC on day 4 for in-depth profiling circadian physiology. Participants will be discharged on the morning of day 5.",[13,14],[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Walnut consumption","Participants will add one serving (1 oz) of walnuts at their self-defined breakfast, lunch, and dinner for 4 days. The study will provide study foods at 3 main meals each day to evaluate a temporal effect of the food on melatonin concentrations throughout the day.",[16,9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"HCHS consumption","Participants will add one HCHS food (one PopTarts® pastry) to each of their 3 main meals of the day for 4 days. The study will provide study foods at 3 main meals each day to evaluate a temporal effect of the food on melatonin concentrations throughout the day.\n\nAn energy-matched high-carbohydrate, high-sugar (HCHS) alternative, representative of a common US snack food, on sleep quality in adults with habitually poor sleep quality.",[16,9],[30],{"name":31,"affiliation":32,"role":33},"Marie-Pierre St-Onge, PhD","Associate Professor of Nutritional Medicine","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":24,"email":39},"Joseariel Romero","CONTACT","347-963-8845","jr4119@cumc.columbia.edu",{"name":41,"role":37,"phone":42,"phoneExt":24,"email":43},"Claudia Dreyer, BS","347-881-6008","cd3003@cumc.columbia.edu",[45],{"facility":46,"status":47,"city":48,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Columbia University Irving Medical Center","RECRUITING","New York","10032","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-74.00597,40.71427,{"lat":56,"lon":55},[59,60,61],{"name":36,"role":37,"phone":38,"phoneExt":24,"email":39},{"name":41,"role":37,"phone":42,"phoneExt":24,"email":43},{"name":31,"role":33,"phone":24,"phoneExt":24,"email":24},{"type":33,"investigatorFullName":63,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Marie-Pierre St-Onge",[65,68],{"name":66,"class":67},"United States Department of Agriculture (USDA)","FED",{"name":69,"class":6},"California Walnut Commission","100549136","mechanistic-effect-of-walnut-consumption-on-sleep-quality-100549136",false,"NCT06430086","Mechanistic Effect of Walnut Consumption on Sleep Quality","Inclusion Criteria:\n\n* Equal numbers of men and women (12 male and 12 post-menopausal female)\n* Equal number of individuals with normal weight (18.5-24.9 kg\u002Fm2) and overweight (25-29.9 kg\u002Fm2)\n* Participants will self-report poor sleep quality, reflected by a global score \\>5 on Pittsburgh Sleep Quality Index\n\nExclusion Criteria:\n\n* Diagnosed sleep disorder\n* Participants with conditions that could affect sleep will be excluded:\n\n  * smoking, excessive caffeine intake (\\>300 mg\u002Fday)\n  * shift work\n  * chronic pain\n  * diagnosis of a chronic disease (e.g., uncontrolled hypertension, pre-diabetes, type 2 diabetes, chronic kidney disease, chronic obstructive pulmonary disease),\n  * autoimmune diseases\n  * cardiovascular event or cancer in the past 24 months\n  * psychiatric\u002Fneurologic disease or disorder, or sleep disorder (diagnosed or high risk for sleep apnea, chronic insomnia, restless leg syndrome, narcolepsy)\n  * use of medications that influence CYP1A2 enzymes\n* Allergy\u002Fintolerance to nuts, tree nuts, or unwilling to eat study foods",true,"ALL","45 Years","65 Years",{"count":81,"type":82},24,"ESTIMATED","INTERVENTIONAL",[85],"NA","Poor sleep quality is very common in modern society. Walnuts contain many nutrients that may be helpful for sleep, including melatonin and polyphenols. Some studies show that eating foods high in melatonin and polyphenols improves sleep quality, but walnuts have not been studied specifically. This study proposes to test if eating walnuts improves sleep compared to a food that lacks these sleep-promoting factors. The investigators expect that walnut consumption for 4 days will increase melatonin levels and lead to better sleep quality compared to a high-carbohydrate, high-sugar food. The study will enroll middle-aged and older adults with sleep complaints to participate in this study. Each person will eat the two different foods for 4 days each in random order. The 4-day periods will be separated by at least 2-3 weeks. Sleep quality will be measured by questionnaire and with a wrist monitor every day. The investigators will also do a sleep study using electroencephalography (EEG) on night 3 and take measures of circadian physiology (natural body rhythms) in the laboratory on day 4 (including overnight) by measuring body temperature and blood and urine melatonin. The study findings may provide new options to improve sleep health from increased walnut consumption.",[88],"Poor Sleep Quality",[90,91,92,93,94],"Randomized crossover study","Controlled feeding","Dietary intervention","Inpatient visit","Outpatient monitoring","2025-07-29",{"date":97,"type":98},"2025-07-31","ACTUAL",{"date":100,"type":98},"2024-06-28",{"date":102,"type":82},"2026-12-31",{"name":5,"class":6},1]