[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07340125":3,"trial-entities:NCT07340125":114,"trial-summary:NCT07340125":120},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":26,"study_type":33,"primary_purpose":34,"phases":35,"enrollment_info":37,"interventions":40,"primary_outcomes":44,"secondary_outcomes":55,"sex":69,"minimum_age":70,"maximum_age":71,"healthy_volunteers":72,"eligibility_criteria":73,"std_ages":90,"locations":92,"central_contacts":102,"overall_officials":108,"references":112,"see_also_links":113},"NCT07340125","Pro00145186","Pistachio Snacking and Metabolic Flexibility","Effects of Pistachio Snacking on Metabolic Flexibility in Healthy Overweight and Obese Adults","RECRUITING","2026-12-31","2026-01","2026-01-14","2025-09-01","University of South Carolina","OTHER",false,"The purpose of this study is to evaluate the effects of pistachio snacking on metabolic flexibility (at rest, during exercise, and in post-exercise recovery) in healthy overweight and obese adults. Secondary goals include evaluating effects on changes in diet quality, sleep characteristics, physical activity, and hormonal health in women. In randomized order, participants will complete four days of pistachio snacking and four days of normal dietary habits (control). For both conditions, primary outcomes of resting substrate metabolism, metabolic flexibility during exercise, and post-exercise substrate metabolism will be measured pre-post intervention via indirect calorimetry. Secondary outcome of diet quality (kcal, carb, fat, protein) will be measured pre-post intervention via diet log. Exploratory outcomes of daily physical activity (steps, intensity), nightly sleep characteristics (quantity, quality, latency, efficiency), and daytime sleepiness and hunger.",null,[19,20,21,22,23,24,25],"Overweight (BMI > 25)","Obese But Otherwise Healthy Participants","Overweight or Obese","Obese Patients (BMI ≥ 30 kg\u002Fm²)","Poor Sleep Quality","Healthy Participants","Physically Inactive",[27,28,29,30,31,32],"Pistachio","Tree Nuts","metabolic flexibility","metabolism","diet quality","snacking","INTERVENTIONAL","TREATMENT",[36],"NA",{"count":38,"type":39},60,"ESTIMATED",[41],{"type":14,"name":27,"description":42,"armGroupLabels":43},"Roasted, lightly salted, pistachio kernels (no shell)",[27],[45,49,52],{"measure":46,"description":47,"timeFrame":48},"resting metabolism","resting metabolic rate (RMR) and substrate utilization (RER) via indirect calorimetry","Day 0 and Day 5",{"measure":50,"description":51,"timeFrame":48},"exercise metabolic flexibility","substrate metabolism (RER; indirect calorimetry) throughout a submaximal, graded exercise test",{"measure":53,"description":54,"timeFrame":48},"post-exercise metabolism","Energy expenditure and substrate metabolism (RER) measured at 0, 30, 60, 90min post-exercise via indirect calorimetry",[56,60,63,66],{"measure":57,"description":58,"timeFrame":59},"Caloric Intake","Average calorie intake (kcal) via 24-hr diet record","Day 0 and Day 4",{"measure":61,"description":62,"timeFrame":59},"Carbohydrate Intake","Average carbohydrate intake (grams) via 24-hr diet record",{"measure":64,"description":65,"timeFrame":59},"Protein Intake","Average protein intake (grams) via 24-hr diet record",{"measure":67,"description":68,"timeFrame":59},"Fat Intake","Average fat intake (grams) via 24-hr diet record","ALL","25 Years","45 Years",true,{"inclusion":74,"exclusion":82,"raw_text":89},[75,76,77,78,79,80,81],"Males and Females","Age: 25-45 years","Overweight or obese (BMI=25.0-34.9 kg\u002Fm²)","Poor sleep quality (Pittsburgh Sleep Quality Index ≥ 5)","Healthy (no diagnosed metabolic, cardiovascular, sleep, or other health condition that may significantly alter metabolism, sleep, or ability to participate in the exercise test)","Not meeting weekly physical activity recommendations (\\\u003C150 min moderate-intensity exercise, \\\u003C75 minutes of vigorous-intensity exercise, and \\\u003C2 days of strength training)","Not following a diet that is restrictive or eliminates certain food group\u002Ftypes",[83,84,85,86,87,88],"Allergies to nuts, especially tree nuts","Has a pacemaker","Following a diet that is restrictive or eliminates certain food group\u002Ftypes","Self-repoted health or disease state that may influence study outcomes, including known metabolic or endocrine disorder (e.g. prediabetes, type 1 or type 2 diabetes, or polycystic ovary syndrome), cardiovascular diseases, neuromuscular disorders, musculoskeletal disorders; current or recent history of cancer\u002Fcancer treatment (within the past year)","History of gastrointestinal surgery, hysterectomy","For women: pregnant or thinking of becoming pregnant during the time of participation, pregnant within the last year, currently breastfeeding, or known to be perimenopausal","Inclusion Criteria:\n\n* Males and Females\n* Age: 25-45 years\n* Overweight or obese (BMI=25.0-34.9 kg\u002Fm²)\n* Poor sleep quality (Pittsburgh Sleep Quality Index ≥ 5)\n* Healthy (no diagnosed metabolic, cardiovascular, sleep, or other health condition that may significantly alter metabolism, sleep, or ability to participate in the exercise test)\n* Not meeting weekly physical activity recommendations (\\\u003C150 min moderate-intensity exercise, \\\u003C75 minutes of vigorous-intensity exercise, and \\\u003C2 days of strength training)\n* Not following a diet that is restrictive or eliminates certain food group\u002Ftypes\n\nExclusion Criteria:\n\n* Allergies to nuts, especially tree nuts\n* Has a pacemaker\n* Following a diet that is restrictive or eliminates certain food group\u002Ftypes\n* Self-repoted health or disease state that may influence study outcomes, including known metabolic or endocrine disorder (e.g. prediabetes, type 1 or type 2 diabetes, or polycystic ovary syndrome), cardiovascular diseases, neuromuscular disorders, musculoskeletal disorders; current or recent history of cancer\u002Fcancer treatment (within the past year)\n* History of gastrointestinal surgery, hysterectomy\n* For women: pregnant or thinking of becoming pregnant during the time of participation, pregnant within the last year, currently breastfeeding, or known to be perimenopausal",[91],"ADULT",[93],{"facility":94,"status":8,"city":95,"state":96,"zip":97,"country":98,"geoPoint":99},"Public Health Research Center: Clinical Exercise Research Center","Columbia","South Carolina","29208","United States",{"lat":100,"lon":101},34.00071,-81.03481,[103],{"name":104,"role":105,"phone":106,"email":107},"Callie Unrein, MS","CONTACT","803-777-5478","sustainlab@mailbox.sc.edu",[109],{"name":110,"affiliation":13,"role":111},"Katie R Hirsch, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":115,"biomarkers":119},[116,117,118],"Obesity","Overweight","Sleep Disorder",[],{"nct_id":4,"found":72,"summary":121,"prompt_version":131},{"design":122,"status":123,"heading":124,"summary":125,"follow_up":126,"word_count":127,"commitments":128,"compensation":129,"drugs_mentioned":130},"This is an interventional study planning to enroll 60 participants. You will complete four days of pistachio snacking and four days of normal eating habits in a randomized order.","completed","Pistachio Snacking and Metabolic Flexibility Study","This study is looking at how eating pistachios affects your body's ability to use energy (metabolic flexibility) while resting, exercising, and recovering. We are seeking healthy adults, aged 25-45, who are overweight or obese (BMI between 25.0 and 34.9) and have poor sleep quality. You cannot have other health conditions that might affect your metabolism or sleep. Participants will eat pistachios for four days and then follow their usual diet for four days, in a random order. We will measure your metabolism before and after each period. The study also aims to see how pistachio snacking affects diet quality, sleep, physical activity, and hormones in women. The current status of this study is unclear.","Metabolism measurements are taken at Day 0 and Day 5 for each intervention period.",114,"You will participate in two four-day periods, one with pistachio snacking and one with your usual diet. Metabolism measurements will be taken at the beginning and end of each period, and you will keep a diet log.","Not stated in the trial record.",[27],"v2"]