[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653973":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":51,"studyPopulation":45,"armGroups":52,"interventions":72,"overallOfficials":91,"centralContacts":95,"locations":104,"responsibleParty":122,"collaborators":124,"id":128,"slug":129,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":45,"eligibilityCriteria":134,"healthyVolunteers":135,"sex":136,"minAge":137,"maxAge":138,"enrollmentInfo":139,"targetDuration":45,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":107,"whyStopped":45,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":30},[9,13],{"measure":10,"description":11,"timeFrame":12},"Essential Amino Acid Kinetics","Area under the curve for metabolomic responses","Baseline, 30, 60, and 90 minutes following supplementation during acute visits.",{"measure":14,"description":15,"timeFrame":16},"Substrate Oxidation","Respiratory exchange ratio (RER)","Before (0 min) and after (30, 60, 90 min) one session of high intensity interval training",[18,22,26],{"measure":19,"description":20,"timeFrame":21},"Lean Body Mass","Dual energy x-ray absorptiometry-derived lean soft tissue","Baseline and week 4",{"measure":23,"description":24,"timeFrame":25},"Muscle size","Muscle cross sectional area derived from peripheral quantitative computed tomography","Baseline week 4",{"measure":27,"description":28,"timeFrame":29},"Fluid Kinetics","Total body water","Baseline, week 1, week 2, week 3, week 4",[31,34,38],{"measure":32,"description":33,"timeFrame":21},"Muscle Oxygen Capacity","Near infrared spectroscopy",{"measure":35,"description":36,"timeFrame":37},"Mood","Questionnaire derived mood and fatigue from patient-reported outcomes measurement information system (PROMIS), score range 30-60, with higher scores representing worse mood.","Baseline, week 4",{"measure":39,"description":40,"timeFrame":37},"Skin","Skin texture measured from the patient reported outcome measure, scored from 0 (lowest satisfaction\u002Fworst outcome) to 100 (highest satisfaction\u002Fbest outcome).",{"allocation":42,"interventionModel":43,"interventionModelDescription":44,"primaryPurpose":6,"observationalModel":45,"timePerspective":45,"maskingInfo":46},"RANDOMIZED","PARALLEL","This study incorporates two randomized intervention components within a single protocol. The primary trial is a double-blind, parallel-group study in which participants are randomized to receive either Daily Upgrade EAA+ or placebo during a 3-week supervised high-intensity interval training (HIIT) intervention. Embedded within the overall trial is an acute, randomized, double-blind crossover substudy in which a subset of participants completes three experimental visits and receives Daily Upgrade EAA+, whey protein isolate, and placebo in randomized order to evaluate acute metabolomic, metabolic, and physiological responses before and after HIIT.",null,{"masking":47,"maskingDescription":45,"whoMasked":48},"DOUBLE",[49,50],"PARTICIPANT","INVESTIGATOR","The trial includes an acute crossover phase and a chronic parallel-group phase. In the acute phase, participants complete three randomized laboratory visits during which they consume Daily Upgrade EAA+, whey protein isolate, or a non-caloric placebo prior to a standardized high-intensity interval training (HIIT) session. Metabolomic responses, amino acid kinetics, metabolic outcomes are assessed before and after exercise.\n\nIn the chronic phase, participants are randomized to consume Daily Upgrade EAA+ or placebo daily for three weeks while completing supervised HIIT sessions twice per week. Outcomes assessed before and after the intervention include body composition, exercise performance, fluid balance, and gastrointestinal symptoms.",[53,60,66],{"label":54,"type":55,"description":56,"interventionNames":57},"Essential Amino Acids+","EXPERIMENTAL","Essential amino acids, creatine, magnesium, electrolytes consumed once (daily) with 8-12 oz of water.",[58,59],"Dietary Supplement: Essential Amino Acid+","Behavioral: High intensity Interval Training",{"label":61,"type":62,"description":63,"interventionNames":64},"Placebo Comparator","PLACEBO_COMPARATOR","Non-caloric placebo consumed once (daily) with 8-12 oz of water",[65,59],"Dietary Supplement: Non-Calorie Placebo",{"label":67,"type":68,"description":69,"interventionNames":70},"Whey Protein Isolate","ACTIVE_COMPARATOR","1 serving whey protein isolate mixed with 8-12 oz of water",[71],"Other: No Exercise",[73,78,82,87],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":45},"DIETARY_SUPPLEMENT","Essential Amino Acid+","Daily supplementation of essential amino acids",[54],{"type":74,"name":79,"description":80,"armGroupLabels":81,"otherNames":45},"Non-Calorie Placebo","Daily supplementation with non-caloric placebo",[61],{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":45},"BEHAVIORAL","High intensity Interval Training","Twice weekly high intensity interval training for 3 weeks",[54,61],{"type":6,"name":88,"description":89,"armGroupLabels":90,"otherNames":45},"No Exercise","No exercise",[67],[92],{"name":93,"affiliation":5,"role":94},"Abbie Smith-Ryan, PhD","PRINCIPAL_INVESTIGATOR",[96,100],{"name":93,"role":97,"phone":98,"phoneExt":45,"email":99},"CONTACT","919-962-2574","abbiesmith@unc.edu",{"name":101,"role":97,"phone":102,"phoneExt":45,"email":103},"Research Coordinator","919-962-1663","aplresearch@unc.edu",[105],{"facility":106,"status":107,"city":108,"state":109,"zip":110,"country":111,"countryCode":112,"cosmosGeoPoint":113,"geoPoint":118,"contacts":119},"Applied Physiology Laboratory","RECRUITING","Chapel Hill","North Carolina","27599","United States","US",{"type":114,"coordinates":115},"Point",[116,117],-79.05584,35.9132,{"lat":117,"lon":116},[120,121],{"name":101,"role":97,"phone":102,"phoneExt":45,"email":103},{"name":93,"role":94,"phone":45,"phoneExt":45,"email":45},{"type":123,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR",[125],{"name":126,"class":127},"Sportiv, Inc.","UNKNOWN","100653973","daily-upgrade-trial-100653973",false,"NCT07792603","Daily Upgrade Trial","TONE UP: Daily Upgrade Trial: Tone, Oxygenation, Neuromood, Energy - Upgrade Evaluation","Inclusion Criteria:\n\n* Participant is an adult between the ages of 25-45 years\n* Participant has a recorded BMI between 18.5-30 kg\u002Fm\\^2\n* Participant is apparently healthy and free from disease, as determined by a health history questionnaire\n* Participant is a biological female\n* Participant is naturally menstruating or uses a form of hormonal contraceptive\n* Participant is recreationally active, based on the International Physical Activity Questionnaire- Short Form\n* Participant agrees to abstain from caffeine (12 hours), tobacco, alcohol, and exercise for 24 hours prior to testing days\n* Participant is willing and able to comply with the protocol\n\nExclusion Criteria:\n\n* Participant has been diagnosed with chronic heart disease, arrhythmias, thyroid disease, renal, hepatic, autoimmune or neurological diseases, as determined by a health history questionnaire.\n* Participant has a musculoskeletal disorder or injury that would prohibit them from being able to safely complete the study protocol.\n* Participant is currently enrolled in a separate clinical trial or weight loss program involving diet, exercise, physical activity, or the potential ingestion of an active drug or dietary supplement\n* Participant is using, or has consistently used one of the following dietary supplements within 1 month prior to enrollment: whey protein, creatine, essential amino acids\n* Participant has a known allergy or sensitivity to the placebo or active ingredients\n* Participant is pregnant or planning to become pregnant\n* Participant does not speak English or is hearing impaired",true,"FEMALE","25 Years","45 Years",{"count":140,"type":141},44,"ESTIMATED","INTERVENTIONAL",[144],"NA","This study evaluates the acute and chronic effects of an essential amino acid supplement (Daily Upgrade EAA+) on metabolomics, amino acid kinetics, metabolic rate, body composition in active adult women. The study consists of an acute randomized double-blind crossover phase comparing EAA+, whey protein isolate, and placebo before high-intensity interval training (HIIT), and a chronic randomized double-blind parallel-arm phase evaluating 3 weeks of EAA+ or placebo supplementation combined with twice-weekly HIIT.",[147],"Healthy Women",[149,150,151,152],"Dietary Supplement","Exercise training","Amino Acid","Body composition","2026-09-02",{"date":155,"type":156},"2026-09-03","ACTUAL",{"date":158,"type":156},"2026-08-31",{"date":160,"type":141},"2027-04",{"name":5,"class":6},1]