[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653924":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":49,"studyPopulation":38,"armGroups":50,"interventions":65,"overallOfficials":38,"centralContacts":84,"locations":90,"responsibleParty":104,"collaborators":38,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":115,"sex":116,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":38,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":38,"overallStatus":129,"whyStopped":38,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"University of Texas at Austin","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":38},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Cognitive assessment: Montreal Cognitive Assessment (MoCA)","The Montreal Cognitive Assessment is a standard questionnaire which was developed to test for cognitive impairment. The MoCA assesses a variety of cognitive functions including executive function, memory, attention, and verbal fluency. Minimum=0; Maximum=30; low score=more impairment.","The MoCA will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)",{"measure":14,"description":15,"timeFrame":16},"Cognitive assessment: Trail-Making Test","The trail-making test (TMT) is a paper-and-pencil \"connect-the-dots\" task which is used to test visual attention and cognitive flexibility. Completion time (seconds) and number of errors are recorded. Faster time and lower errors=better performance. Maximum time alloted=300 seconds.","The TMT will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)",{"measure":18,"description":19,"timeFrame":20},"Brain metabolism assessment: Functional Near-Infrared Spectroscopy (fNIRS)","Participants wear a device on the head which assesses brain metabolism non-invasively using functional near-infrared spectroscopy. The device records changes in the concentrations of oxygenated hemoglobin in the prefrontal cortex of the brain.","The fNIRS procedure will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)",[22,26,30,34],{"measure":23,"description":24,"timeFrame":25},"Cognitive assessment: 2-Back Task","The 2-back task is a standard computer-based test that assesses attention and short-term memory, in which participants remember a series of letters presented onscreen. Accuracy (number of errors) and speed (reaction time in seconds) are recorded. Faster time and lower errors=better performance. Duration: 5 minutes.","The 2-back task will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)",{"measure":27,"description":28,"timeFrame":29},"Cognitive assessment: Delayed Match-to-Sample Task (DMS)","The DMS is a standard computer-based test that assesses visuospatial memory and attention, in which participants remember a grid pattern through a delay and then identify the correct match. Number of correct responses and reaction time in seconds are measured. Faster time and lower errors=better performance. Duration=5 minutes.","The DMS will be administered: 1. Pre-treatment (during Visit 1); 2. Post-treatment (Visit 2, two months later)",{"measure":31,"description":32,"timeFrame":33},"Weekly check-in","Open response, verification of compliance of treatment","Once per week during treatment",{"measure":35,"description":36,"timeFrame":37},"Follow-up","Open response of any long-term effects of treatment","One month after Visit 2",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":38,"primaryPurpose":6,"observationalModel":38,"timePerspective":38,"maskingInfo":42},"RANDOMIZED","FACTORIAL",{"masking":43,"maskingDescription":38,"whoMasked":44},"QUADRUPLE",[45,46,47,48],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","The Gonzalez-Lima Laboratory at the University of Texas at Austin is recruiting participants for a research study. The study examines whether a combined treatment can improve cognitive function. The treatment includes transcranial photobiomodulation (tPBM), a form of light therapy applied to the forehead, along with a dietary supplement. The treatment targets an enzyme called cytochrome-c-oxidase, which plays a key role in how the mitochondria inside brain cells use oxygen to produce energy. As people age, this process often becomes less efficient, contributing to cognitive decline seen in normal aging and in neurodegenerative diseases. The hypothesis is that improving mitochondrial function and cytochrome-c-oxidase activity will boost neuronal energy production and reduce oxidative stress, ultimately enhancing cognitive performance. Previous studies from the Gonzalez-Lima Lab found that applying tPBM to the prefrontal cortex improves brain metabolic activity and enhances cognitive functions such as attention, memory, and executive function. The dietary supplement provides an alternative energy source derived from ketones, which mitochondria can use for oxygen metabolism. This may help bypass the impaired glucose metabolism often seen in aging brains, potentially leading to further cognitive improvements. This study will investigate the cognitive effects of this combined treatment in adults ages 18 to 85. During the first visit to the lab, participants will complete informed consent, health questionnaires, and cognitive assessments, and wear sensors on the head which monitor brain activity. They will also be trained to use a headset device which uses light-emitting diodes (LEDs) to deliver light to the forehead. They will be given daily supplements and instructed on how to maintain a daily log for at-home treatments. Then, for the next two months, participants will complete the daily protocol at home. Weekly check-ins will monitor progress throughout this period. After two months, participants will return to repeat the assessments from the first visit and return their study materials. Participants will receive $200 upon completing the study, and parking expenses will be reimbursed for each visit. Briefly, one aim will be to map the relationship between baseline prefrontal functional connectivity and dimensional performance in cognitive control and affective processing. Another aim will be to evaluate mechanistic efficacy of chronic tPBM in engaging prefrontal circuits and restoring task-based behavioral performance. A final aim is to model the longitudinal relationship between prefrontal circuit health and real-world sleep, circadian stability, and neuroendocrine regulation. By focusing on target-driven biobehavioral mechanisms, this study aims to identify novel therapeutic targets and establish scalable biomarker pipelines.",[51,58],{"label":52,"type":53,"description":54,"interventionNames":55},"Arm 1: active tPBM, active MCT dietary supplementation","ACTIVE_COMPARATOR","Participants in this arm will receive active transcranial photobiomodulation to the forehead, targeting prefrontal cortex, and active dietary supplementation with refined coconut oil to provide ketones.",[56,57],"Device: Active transcranial photobiomodulation","Dietary Supplement: Active MCT dietary supplementation",{"label":59,"type":60,"description":61,"interventionNames":62},"Arm 2: sham tPBM, sham dietary supplementation","SHAM_COMPARATOR","Participants in this arm will undergo the same procedures as the active group, but with sham photobiomodulation (5% of experimental light emitted by the device) and sham dietary supplementation with sunflower oil (comparable caloric value without ketone production).",[63,64],"Device: Sham photobiomodulation","Dietary Supplement: Sham dietary supplementation",[66,71,76,80],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":38},"DEVICE","Active transcranial photobiomodulation","Infrared light delivered to the forehead, administered with a headset using light-emitting diodes (LEDs)",[52],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":38},"DIETARY_SUPPLEMENT","Active MCT dietary supplementation","Commercially-available food-grade refined coconut oil for ketogenic dietary supplementation",[52],{"type":67,"name":77,"description":78,"armGroupLabels":79,"otherNames":38},"Sham photobiomodulation","Identical procedure as active group, but with 5% of light emitted by the device.",[59],{"type":72,"name":81,"description":82,"armGroupLabels":83,"otherNames":38},"Sham dietary supplementation","Identical appearance and administration as active dietary supplementation, but with commercially-available food-grade sunflower oil (comparable caloric value without ketone production).",[59],[85],{"name":86,"role":87,"phone":88,"phoneExt":38,"email":89},"Francisco Gonzalez-Lima","CONTACT","(512) 703-1804","utcognitivestudy@gmail.com",[91],{"facility":92,"status":38,"city":93,"state":94,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":103,"contacts":38},"The University of Texas at Austin","Austin","Texas","78712","United States","US",{"type":99,"coordinates":100},"Point",[101,102],-97.74306,30.26715,{"lat":102,"lon":101},{"type":105,"investigatorFullName":106,"investigatorTitle":107,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"SPONSOR_INVESTIGATOR","Francisco Gonzalez-Lima, PhD","Professor","100653924","increasing-mitochondrial-respiration-as-a-novel-mechanism-for-cognitive-augmentation-100653924",false,"NCT07793604","Increasing Mitochondrial Respiration as a Novel Mechanism for Cognitive Augmentation","MITOCOG","Inclusion Criteria:\n\n* Age: 18-85 years old\n* No uncorrected visual, auditory, or motor impairments that would interfere with performing cognitive tasks\n\nExclusion Criteria:\n\n* Transcranial photobiomodulation in the last six weeks\n* Diabetes\n* Pregnancy or plans to become pregnant\n* Breastfeeding or plans to breastfeed\n* Major depressive disorder\n* Psychotic disorders\n* Suicidal ideation within the past 6 months\n* Plans for serious medical procedures in the next 3 months\n* Serious hepatic or liver-related conditions\n* History of neurotrauma (e.g., brain lesions or traumatic brain injury)\n* Presently on a ketogenic diet",true,"ALL","18 Years","85 Years",{"count":120,"type":121},180,"ESTIMATED","INTERVENTIONAL",[124],"NA","The purpose of this study is to investigate the effects of increasing brain energy on cognition. The hypothesis is that by using a special kind of light, in combination with a nutritional supplement, it may be possible to increase energy production in the brain, which may lead to improvements in cognition.",[127,128],"Cognition Improvement","Emotion Regulation","NOT_YET_RECRUITING","2026-08-26",{"date":132,"type":133},"2026-08-28","ACTUAL",{"date":135,"type":121},"2026-10-01",{"date":137,"type":121},"2030-05",{"name":106,"class":6},1]