[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07218822":3,"trial-entities:NCT07218822":117,"trial-summary:NCT07218822":121},{"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":49,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":86,"locations":88,"central_contacts":105,"overall_officials":113,"references":115,"see_also_links":116},"NCT07218822","AAAV9510","Impact of Pistachio Consumption on Sleep","RECRUITING","2027-08-31","2026-02","2026-02-13","2025-12-12","Columbia University","OTHER",false,"Sleep is essential for life and overall health. Unfortunately, a large portion of the population in the U.S. and worldwide experience sleep deficiencies, which increase their risk for developing chronic diseases. These sleep difficulties often cause distress, leading individuals to seek various forms of treatment. Given that some drugs cause habituation and undesirable side effects, individuals often turn to over-the-counter sleep remedies. However, long-term use of over-the-counter treatments is not recommended by the American Academy of Sleep Medicine for insomnia treatment and there is currently no recommendation related to dietary management. There is a strong need to identify natural measures to improve sleep in millions of adults battling poor sleep. Diet is emerging as a potentially important modulator of sleep. Despite observational data linking greater nut intake with better sleep, and that pistachios contain a significant number of sleep-promoting compounds, no study to date has evaluated the impact of pistachio supplementation on sleep. To address this key knowledge gap, the investigators propose to conduct a randomized controlled trial to evaluate the impact of pistachio consumption, relative to a calorie-matched control food, on sleep in middle-aged adults with poor sleep and to explore underlying mechanisms.",null,[18],"Poor Quality Sleep",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},28,"ESTIMATED",[28,33],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DIETARY_SUPPLEMENT","Pistachio","2 servings\u002Fday for 4 weeks (56 g total\u002Fday)",[30],{"type":29,"name":34,"description":35,"armGroupLabels":36},"Control food","Muffins and cookies (no nuts), at an equivalent number of calories as the pistachio intervention, daily",[37],"Control",[39,43,46],{"measure":40,"description":41,"timeFrame":42},"Self-reported sleep quality","Self-reported sleep quality will be reported by the score on the Pittsburgh Sleep Quality Index. The full score range is 0 to 21, where a higher score indicates worse sleep quality.","4 weeks",{"measure":44,"description":45,"timeFrame":42},"Objective sleep quality","Sleep fragmentation index assessed by wrist actigraphy. This is a measure of how frequently sleep is interrupted, calculated as the sum of the percentage of all scored epochs with one or more activity counts during time in bed and percentage of one-minute periods of sleep vs all periods of sleep during the sleep period.",{"measure":47,"description":48,"timeFrame":42},"Overnight melatonin production","Amount of 6-sulfatoxymelatonin present in urine collected overnight, reported as ng\u002Fmg creatinine (corrected for creatinine content).",[50,53,56,59],{"measure":51,"description":52,"timeFrame":42},"Sleep efficiency","Percent of time in bed spent asleep from wrist actigraphy",{"measure":54,"description":55,"timeFrame":42},"Sleep depth","Time spent in deep sleep from home sleep test",{"measure":57,"description":58,"timeFrame":42},"Sleepiness","Sleepiness will be reported by the score on the Epworth Sleepiness Scale. The full score range is 0 - 10, where a higher score indicates greater sleepiness.",{"measure":60,"description":61,"timeFrame":42},"Insomnia symptoms","Insomnia symptoms will be assessed using the Insomnia Severity Index. The full score range is 0 - 28, where a higher score indicates more severe insomnia.","ALL","45 Years","64 Years",true,{"inclusion":67,"exclusion":73,"raw_text":85},[68,69,70,71,72],"Poor sleep quality, Pittsburgh Sleep Quality Index score \\>5","BMI 20 - 29.9 kg\u002Fm\\^2","Ability to abstain from travel across time zones","Willingness to eat study foods","Willingness\u002Fability to discontinue use of vitamin and mineral supplements",[74,75,76,77,78,79,80,81,82,83,84],"Premenopausal women","Medical or living conditions that could affect sleep:","Smoking","Excessive caffeine intake (\\>300 mg\u002Fday)","Non-day shift work","Chronic pain","Diagnosis of a chronic disease (e.g., uncontrolled hypertension, pre-diabetes, type 2 diabetes, chronic kidney disease, chronic obstructive pulmonary disease)","Autoimmune diseases, cardiovascular event or cancer in the past 24 months","Psychiatric\u002Fneurologic disease or disorder, or sleep disorder (diagnosed or high risk for sleep apnea, chronic insomnia, restless leg syndrome, narcolepsy)","Allergy or intolerance to nuts or study foods","Use of medications that influence CYP1A2 and selective serotonin reuptake inhibitors","Inclusion Criteria:\n\n* Poor sleep quality, Pittsburgh Sleep Quality Index score \\>5\n* BMI 20 - 29.9 kg\u002Fm\\^2\n* Ability to abstain from travel across time zones\n* Willingness to eat study foods\n* Willingness\u002Fability to discontinue use of vitamin and mineral supplements\n\nExclusion Criteria:\n\n* Premenopausal women\n* Medical or living conditions that could affect sleep:\n\n  * Smoking\n  * Excessive caffeine intake (\\>300 mg\u002Fday)\n  * Non-day 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, 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* Allergy or intolerance to nuts or study foods\n* Use of medications that influence CYP1A2 and selective serotonin reuptake inhibitors",[87],"ADULT",[89],{"facility":90,"status":7,"city":91,"state":91,"zip":92,"country":93,"contacts":94,"geoPoint":102},"Columbia University Irving Medical Center","New York","10032","United States",[95,99],{"name":96,"role":97,"email":98},"Marie-Pierre St-Onge, PhD","CONTACT","ms2554@cumc.columbia.edu",{"name":100,"role":101},"Marie-Pierre St-Onge","PRINCIPAL_INVESTIGATOR",{"lat":103,"lon":104},40.71427,-74.00597,[106,110],{"name":107,"role":97,"phone":108,"email":109},"Diane Hawkins","347-963-8845","dh3078@cumc.columbia.edu",{"name":111,"role":97,"email":112},"Joseariel Romero","jr4119@cumc.columbia.edu",[114],{"name":100,"affiliation":12,"role":101},[],[],{"nct_id":4,"conditions":118,"biomarkers":120},[119],"Quality of sleep",[],{"nct_id":4,"found":65,"summary":122,"prompt_version":132},{"design":123,"status":124,"heading":125,"summary":126,"follow_up":127,"word_count":128,"commitments":129,"compensation":130,"drugs_mentioned":131},"This is an interventional study, meaning participants will receive a specific intervention. It plans to enroll 28 participants to compare pistachio consumption against a control food.","completed","Pistachio Consumption and Sleep Quality Study","This study is looking at whether eating pistachios can improve sleep quality. Researchers are comparing people who eat pistachios daily to those who eat control foods (muffins and cookies without nuts) for four weeks. They want to see if pistachios affect how well people sleep, both by what they report and by objective measures, and if it impacts melatonin production (a hormone that helps with sleep). You might be able to join if you are between 45 and 64 years old, have poor sleep quality (a score over 5 on the Pittsburgh Sleep Quality Index), and have a BMI between 20 and 29.9. The study is looking for 28 participants, but its current recruitment status is unclear.","Sleep quality and melatonin production will be measured at 4 weeks, which is the end of the intervention period.",117,"Participants will eat study foods (pistachios or control foods) daily for 4 weeks. They will also need to stop taking vitamin and mineral supplements.","Not stated in the trial record.",[30,34],"v2"]