[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03990909":3,"trial-entities:NCT03990909":109,"trial-summary:NCT03990909":113},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":45,"secondary_outcomes":56,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":15,"eligibility_criteria":64,"std_ages":77,"locations":80,"central_contacts":97,"overall_officials":100,"references":103,"see_also_links":108},"NCT03990909","MIRB 4312","Pilot Study of BCAA on Sleep","A Pilot Study of Dietary Supplementation With Branched Chain Amino Acids on Sleep","RECRUITING","2025-12-01","2025-11","2025-11-14","2019-03-01","Portland VA Medical Center","FED",false,"Individuals will be recruited from the VA Portland Health Care System and the community affiliated with Oregon Health \\& Science University. Traumatic brain injury status will be assessed as a contributing factor. Subjects will be randomized to one of 3 groups (BCAA or one of 2 placebo conditions) and instructed to consume study product twice daily for 21 days. Self-report questionnaires, wrist actigraphy, pressure pain testing, and cognitive function will be assessed pre and post the experimental period.","The goal of this proposal is to explore the feasibility of, and potential for, dietary supplementation with branched chain amino acids (BCAAs) to effect sleep quality and cognitive function in Veterans. The BCAAs (Leucine, Isoleucine, and Valine) cannot be synthesized endogenously (i.e., they must be obtained through the diet) and are the precursors to \\>50% of de novo glutamate and GABA synthesis in the brain, which are the primary excitatory and inhibitory neurotransmitters, respectively. Preclinical evidence strongly suggests that dietary BCAA supplementation restores normal sleep-wake patterns and cognitive function following TBI through a restoration in the global cortical excitation:inhibition ratio. BCAA supplementation has been studied extensively in healthy humans and in a variety of disease states, including following TBI, but not yet in Veterans in the chronic phase of recovery from TBI. BCAAs are a commercially available dietary supplement and very well tolerated with minimal side-effects.\n\nSubjects will be randomized in a double-blind fashion through the VA Research Pharmacy to one of three groups: 1) BCAA; 60 g\u002Fday in two 30 g doses, 2) rice protein; 60 g\u002Fday in two 30 g doses, and 3) placebo; 60 g microcrystalline cellulose in two 30 g doses. BCAA and placebo will be prepared by the VA Research Pharmacy and dispensed in a blinded fashion to Veterans after demonstrating informed consent. Following a \\~4-week period of baseline, Veterans will be instructed to consume study product after waking and \\~6 hours later, on an empty stomach for a period of up to 21-days. Self-report questionnaires assessing sleep quality, cognitive function, trauma-related symptom severity, and other measures of mental and physical well-being will be administered before and after the experimental period. Wrist actigraphy will be continuously collected over the baseline and the experimental period. Cognitive function will be assessed before and after the experimental period using an established battery of neuropsychological tests (i.e., selected tests from WAIS, D-KEFS, HVLT, COWAT, among others. Pressure pain testing will be conducted before and after the experimental period.",[19,20],"Sleep Disorder","Traumatic Brain Injury",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},300,"ESTIMATED",[30,37,41],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"DIETARY_SUPPLEMENT","Branched Chain Amino Acids","60 grams of BCAA (2:1:1 ratio of Leucine:Isoleucine:Valine) consumed in two doses (30 grams each) mixed into 20 oz of water for up to21days (42 total drinks).",[35],"BCAAs",[35],{"type":31,"name":38,"description":39,"armGroupLabels":40},"Rice Protein","60 grams of rice protein consumed in two doses (30 grams each) mixed into 20 oz of water for up to 21days (42 total drinks).",[38],{"type":31,"name":42,"description":43,"armGroupLabels":44},"Microcrystalline Cellulose","60 grams of microcrystalline cellulose, consumed in two doses (30 grams each) mixed into 20 oz of water for up to 21days (42 total drinks).",[42],[46,50,53],{"measure":47,"description":48,"timeFrame":49},"Recruitment and retention rates","Number enrolled per month, proportion who complete the protocol","5 weeks",{"measure":51,"description":52,"timeFrame":49},"Rates of adherence and treatment fidelity","Proportion of subjects consuming full doses",{"measure":54,"description":55,"timeFrame":49},"Assessment process and patient acceptability","Proportion of questionnaires properly completed, actiwatches properly worn, and patient acceptance of protocol",[57],{"measure":58,"description":59,"timeFrame":60},"Change in Insomnia Severity Index (ISI)","Measures self-reported insomnia severity; total score range = 0-28 (higher total score = worse insomnia)","Baseline; after 3 weeks of intervention","ALL","18 Years","89 Years",{"inclusion":65,"exclusion":70,"raw_text":76},[66,67,68,69],"Veteran","English Speaking","Accessible via phone","Sleep problems",[71,72,73,74,75],"Decisional impairment","Nickel allergy","Maple syrup urine disease or family history of disease","Allergy to sucralose","Currently taking BCAAs","Inclusion Criteria:\n\n* Veteran\n* English Speaking\n* Accessible via phone\n* Sleep problems\n\nExclusion Criteria:\n\n* Decisional impairment\n* Nickel allergy\n* Maple syrup urine disease or family history of disease\n* Allergy to sucralose\n* Currently taking BCAAs",[78,79],"ADULT","OLDER_ADULT",[81],{"facility":82,"status":8,"city":83,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":94},"VA Portland Health Care System","Portland","Oregon","97239","United States",[88],{"name":89,"role":90,"phone":91,"phoneExt":92,"email":93},"Miranda M Lim, MD, PhD","CONTACT","503-220-8262","57404","lmir@ohsu.edu",{"lat":95,"lon":96},45.52345,-122.67621,[98],{"name":89,"role":90,"phone":91,"phoneExt":99,"email":93},"Ext. 57404",[101],{"name":89,"affiliation":13,"role":102},"PRINCIPAL_INVESTIGATOR",[104],{"pmid":105,"type":106,"citation":107},"35602971","DERIVED","Elliott JE, Keil AT, Mithani S, Gill JM, O'Neil ME, Cohen AS, Lim MM. Dietary Supplementation With Branched Chain Amino Acids to Improve Sleep in Veterans With Traumatic Brain Injury: A Randomized Double-Blind Placebo-Controlled Pilot and Feasibility Trial. Front Syst Neurosci. 2022 May 4;16:854874. doi: 10.3389\u002Ffnsys.2022.854874. eCollection 2022.",[],{"nct_id":4,"conditions":110,"biomarkers":112},[19,111],"Traumatic Encephalopathy",[],{"nct_id":4,"found":114,"summary":115,"prompt_version":125},true,{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This is an interventional study planning to enroll 300 participants. Participants will be randomly assigned to one of three groups in a double-blind fashion (meaning neither you nor the researchers will know which product you are receiving).","completed","Pilot Study of BCAA on Sleep for Veterans with Sleep Disorders","This study is looking into whether a dietary supplement called Branched Chain Amino Acids (BCAA) could help improve sleep and thinking skills in Veterans who have sleep problems, possibly related to a traumatic brain injury. You would be given either BCAA, rice protein, or microcrystalline cellulose (placebo) to drink twice a day for 21 days. Researchers want to see if it's practical to run a larger study like this, how many people join and stick with it, and if the process is acceptable to participants. This study is currently recruiting and aims to enroll 300 participants. To join, you must be a Veteran, speak English, have sleep problems, and be between 18 and 89 years old.","Assessments will be conducted at 5 weeks, which includes measuring recruitment, retention, adherence, and acceptability.",116,"You would consume a study product mixed in water twice daily for 21 days. Before and after this period, you will complete questionnaires, wear a wrist device to track activity, undergo pressure pain testing, and have your cognitive function assessed.","Not stated in the trial record.",[32,38,42],"v2"]