Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-30 @ 11:07 PM
Study NCT ID:
NCT06721793
Status:
RECRUITING
Last Update Posted:
2025-08-26
First Post:
2024-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of a Caffeinated Sports Drink on Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003681', 'term': 'Dehydration'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The type of drink ingested by the subjects will be labeled with a letter in a generic water bottle. During the trial with water a non-caloric, non-sodium-containing sweetener will be used.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Counter balanced cross-over design trial with 4 arms differing only on the type of drink consumed during exercise.\n\nEach trial includes 2 hours of cycling in a warm environment (32ºC), followed by strength and cognitive assessments.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2024-10-03', 'studyFirstSubmitQcDate': '2024-12-03', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '5 kilometer cycling time trial', 'timeFrame': 'During the 3rd time trial which is the last time trial.', 'description': 'Time in minutes of completion the 5 kilometer cycling time trial at the 3rd exercise bout.'}, {'measure': '5 kilometer Time trial performance', 'timeFrame': '2nd time trial', 'description': 'Time to completion the 2nd cycling time trial'}, {'measure': 'Isokinetic stregth', 'timeFrame': 'right after the cycling tests', 'description': 'Peak torque at 60º/sec at dominant knee during extension'}, {'measure': 'Congitive performance 1', 'timeFrame': 'after the completion of strength test', 'description': 'Attention Network Test score'}, {'measure': 'Cognitive performance 2', 'timeFrame': 'after the end of the strength assessment', 'description': 'Working Memory Test score'}, {'measure': 'Congitive test 3', 'timeFrame': 'right after the strength test', 'description': 'Stroop Task score'}], 'secondaryOutcomes': [{'measure': 'Blood glucose', 'timeFrame': 'at the end of the 3rd cycling time trial.', 'description': 'Blood glucose levels during the 3rd cycling time trial.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['caffeine', 'sports drinks', 'hydration'], 'conditions': ['Dehydration', 'Dehydration Related to Exercise']}, 'descriptionModule': {'briefSummary': "Caffeine is known to enhance physical and mental performance, but few beverages combine caffeine with electrolytes and carbohydrates to enhance exercise performance. This study evaluates a caffeinated electrolyte-glucose drink's effect on endurance, strength, and cognition. Using a repeated-measures, cross-over design, 20 trained cyclists will complete one familiarization and four randomized 3-hour experimental trials (Liquid I.V.™ Energy Multiplier, Hydration Multiplier, Sugar-Free Hydration Multiplier, and water). Each trial includes 2 hours of cycling in a warm environment (32ºC), followed by strength and cognitive assessments. Cycling performance, capillary blood, urine, and expiratory gases will be collected.", 'detailedDescription': 'Each subject will complete 5 trials (1 familiarization and 4 experimental) consisting of approximately 2 hours cycling in a warm environment (90ºF), followed by strength assessment and cognitive assessment via questionnaire. Each trial will be identical, with the only difference being the type of drink consumed during each trial. The first trial will be for familiarization without any blood sampling. The rest of the trials will be completed in a randomized order and the drink consumed\n\nCycling Endurance Exercise Performance\n\nThe exercise test will consist of a series of three consecutive cycling sets in a warm environment (90ºF), with each series consisting of:\n\n1. a 30-min submaximal ride (50% maximal power as determined from the initial)\n2. a 5-km time trial race-like performance effort. During each 30 min submaximal rides participants will drink a total 500 mL of fluid spread out during the 30 min. During the 5 km performance test the participants will drink 25 mL of fluid at the end of each kilometer.\n\nAt regular intervals throughout the exercise task, body weight, blood samples, respiratory gasses, and perceptual data will be collected. See study schematic provided below for specific measurement timepoints.\n\nUpon completion of the cycling task subjects will moved to another room with cool temperature (70ºF), where strength and cognitive function will be assessed to determine the influence of each beverage on indices of exercise performance and fatigue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-55\n* Healthy and injury-free (muscle, skeletal) for greater than 2 months\n* Active cyclists who train at least 3 times per week\n* Body mass index (BMI) range of 18.5-30 kg/m2\n\nExclusion Criteria:\n\n* • History of caffeine sensitivity\n\n * Cancer Diagnosis during the last 5 years\n * Pregnancy\n * History of renal disease, hypertension\n * History of a heat stroke\n * Use of testosterone therapy\n * Adults who are unable to consent (impaired decision-making capacity)'}, 'identificationModule': {'nctId': 'NCT06721793', 'acronym': 'NRG', 'briefTitle': 'The Impact of a Caffeinated Sports Drink on Performance', 'organization': {'class': 'OTHER', 'fullName': 'Arizona State University'}, 'officialTitle': 'The Impact of a Caffeinated Sports Drink on Performance', 'orgStudyIdInfo': {'id': 'FP00041543'}, 'secondaryIdInfos': [{'id': 'AWD00039989', 'type': 'OTHER', 'domain': 'ASU'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Water', 'description': 'Water masked with non-caloric and no-sodium', 'interventionNames': ['Dietary Supplement: Water (Placebo)']}, {'type': 'EXPERIMENTAL', 'label': 'Carbohydrate electrolyte solution', 'description': '2% carbohydrate solution with 1,020 mg/L of Sodium', 'interventionNames': ['Dietary Supplement: carbohydrate electrolyte drink']}, {'type': 'EXPERIMENTAL', 'label': 'no-sugar electrolyte solution', 'description': '1% carbohydrate solution with 1,060 mg/L of Sodium', 'interventionNames': ['Dietary Supplement: no-sugar electrolyte drink']}, {'type': 'EXPERIMENTAL', 'label': 'Caffeinated carbohydrate electrolyte solution', 'description': '1% carbohydrate solution with 1,000 mg/L of Sodium, and 200mg/L Caffeine', 'interventionNames': ['Dietary Supplement: Caffeinated Carbohydrate and electrolyte drink']}], 'interventions': [{'name': 'carbohydrate electrolyte drink', 'type': 'DIETARY_SUPPLEMENT', 'description': '2% carbohydrate solution with 1,020 mg/L of Sodium', 'armGroupLabels': ['Carbohydrate electrolyte solution']}, {'name': 'no-sugar electrolyte drink', 'type': 'DIETARY_SUPPLEMENT', 'description': '1% carbohydrate solution with 1,060 mg/L of Sodium', 'armGroupLabels': ['no-sugar electrolyte solution']}, {'name': 'Caffeinated Carbohydrate and electrolyte drink', 'type': 'DIETARY_SUPPLEMENT', 'description': '2% carbohydrate solution with 1,000 mg/L of Sodium, and 200mg/L caffeine', 'armGroupLabels': ['Caffeinated carbohydrate electrolyte solution']}, {'name': 'Water (Placebo)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'flavored water with non-caloric, non-sodium-containing sweetner', 'armGroupLabels': ['Water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stavros Kavouras, PhD', 'role': 'CONTACT', 'email': 'stavros.kavouras@asu.edu', 'phone': '(602) 496-2547'}, {'name': 'Stavros Kavouras, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Arizona State University - Hydration Science Lab', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'centralContacts': [{'name': 'Stavros Kavouras, PhD', 'role': 'CONTACT', 'email': 'stavros.kavouras@asu.edu', 'phone': '(602) 496-2547'}], 'overallOfficials': [{'name': 'Stavros Kavouras, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arizona State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arizona State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Stavros Kavouras', 'investigatorAffiliation': 'Arizona State University'}}}}