Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2025-12-30 @ 2:01 AM
Study NCT ID:
NCT07254832
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2025-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Caffeine and Nicotine Gum on Balance Performance in Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074164', 'term': 'Nicotine Chewing Gum'}, {'id': 'D014993', 'term': 'Xylitol'}], 'ancestors': [{'id': 'D002638', 'term': 'Chewing Gum'}, {'id': 'D053149', 'term': 'Plant Gums'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002182', 'term': 'Candy'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-07-08', 'studyFirstSubmitQcDate': '2025-11-20', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Static Postural Sway Ellipse Area - ProKin 252 Stabilometric Platform', 'timeFrame': 'At each visit: 5 minutes after start of chewing (caffeine gum), 30 minutes after start of chewing (nicotine gum), 20 minutes after start of chewing (xylitol placebo gum), and 0 minutes (no gum) for the control condition; single 30-second trial per visit', 'description': 'Center of pressure (COP) 95% ellipse area during quiet bipedal stance (eyes open; standardized foot position) measured with the ProKin 252. Higher values indicate poorer balance.\n\nUnit of Measure: mm\\^2'}], 'secondaryOutcomes': [{'measure': 'Static Center of Pressure (COP) Path Length - ProKin 252 Stabilometric Platform', 'timeFrame': 'At each visit: 5 minutes after start of chewing (caffeine gum), 30 minutes after start of chewing (nicotine gum), 20 minutes after start of chewing (xylitol placebo gum), and 0 minutes (no gum) for the control condition; single 30-second trial per visit', 'description': 'Total COP excursion length during quiet bipedal stance (eyes open; standardized foot position) measured with the ProKin 252. Higher values indicate poorer balance.\n\nUnit of Measure: mm'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Caffeinated chewing gum', 'Nicotine chewing gum', 'Caffeine', 'Nicotine', 'Dynamic balance', 'Postural control', 'Ellipse area', 'Perimeter length', 'Trained athletes'], 'conditions': ['Athletic Performance', 'Postural Stability', 'Healhty']}, 'descriptionModule': {'briefSummary': 'This randomized, single-blind, placebo-controlled, four-condition crossover study evaluates the acute effects of caffeine gum (\\~3 mg/kg) and nicotine gum (4 mg) on balance performance in healthy, trained adults. Each participant completes four test visits (caffeine gum, nicotine gum, xylitol-based placebo gum, and no-gum control) separated by ≥24 hours. Static and dynamic balance are assessed using the ProKin 252 system under standardized procedures. The primary outcomes are postural sway (ellipse area) and center-of-pressure path length over predefined test trials/time frames. The objective is to determine whether acute administration of these stimulants alters balance-related performance relative to placebo and control.', 'detailedDescription': 'This study evaluates the acute effects of two commonly used stimulants-caffeine and nicotine administered in chewing-gum form-on static and dynamic balance performance in healthy, trained adults. The trial uses a randomized, single-blind, placebo-controlled, four-condition crossover design. Twenty participants complete four laboratory visits scheduled at the same time of day and separated by a washout interval of at least 24 hours. The order of the four conditions is randomized.\n\nInterventions are: (1) caffeine gum at approximately 3 mg/kg, (2) nicotine gum at 4 mg, (3) sugar-free xylitol-based placebo gum, and (4) a no-gum control condition. Pre-testing exposure is standardized across conditions: caffeine gum is chewed for 5 minutes, nicotine gum for 30 minutes, and placebo gum for 20 minutes prior to balance assessments. The control condition involves no gum exposure. All procedures are conducted under uniform laboratory conditions.\n\nBalance performance is assessed immediately after the pre-specified exposure period using the ProKin 252 balance platform. Standardized static and dynamic balance tasks are administered according to device guidelines and site procedures. Primary outcomes are postural sway quantified as ellipse area and center-of-pressure path length over predefined trials/time frames. Additional procedural details (e.g., task sequence, rest intervals, and device settings) are maintained in the study manual to ensure consistency across visits.\n\nThe objective is to determine whether acute administration of caffeine or nicotine, relative to placebo and control, alters balance-related performance indices in healthy, physically active individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be healthy, with no diagnosed neurological or musculoskeletal disorders\n2. Be physically active and have at least 3 years of regular training history\n3. Be between 18 and 30 years of age\n4. Have no balance impairments or vestibular issues\n5. Be non-smoker or not using tobacco during study days\n6. Able to comply with the intervention protocols and attend all test sessions\n7. Provide written informed consent\n\nExclusion Criteria:\n\n1. Training age less than three years,\n2. Having a disease or sports injury that will affect balance performance,\n3. Using a drug or substance that affects balance,\n4. Not being able to comply with or continue the study measurements.'}, 'identificationModule': {'nctId': 'NCT07254832', 'briefTitle': 'Effects of Caffeine and Nicotine Gum on Balance Performance in Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'No Significant Alterations in Balance Performance After Acute Caffeine and Nicotine Gum Intake in Trained Athletes', 'orgStudyIdInfo': {'id': 'EGE-24-3.1T-81'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'caffeine gum', 'interventionNames': ['Dietary Supplement: Caffeine Gum 3mg/kg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nicotine Gum', 'interventionNames': ['Dietary Supplement: Nicotine Gum (4 mg)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Gum', 'interventionNames': ['Other: Placebo Gum (Xylitol)']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No chewing gum administered; participants completed balance testing without any intervention.'}], 'interventions': [{'name': 'Caffeine Gum 3mg/kg', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants chewed 2-3 pieces of 100 mg caffeine gum (\\~3 mg/kg total) for 5 minutes prior to balance testing.', 'armGroupLabels': ['caffeine gum']}, {'name': 'Nicotine Gum (4 mg)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants chewed one piece of 4 mg nicotine gum for 30 minutes before undergoing balance testing.', 'armGroupLabels': ['Nicotine Gum']}, {'name': 'Placebo Gum (Xylitol)', 'type': 'OTHER', 'description': 'Participants chewed xylitol-based sugar-free gum with no active substance for 20 minutes prior to testing.', 'armGroupLabels': ['Placebo Gum']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University, Faculty of Sport Sciences', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gülbin Rudarlı', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Sport Sciences, Department of Coaching Education', 'investigatorFullName': 'Gülbin Rudarlı', 'investigatorAffiliation': 'Ege University'}}}}