Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT07150533
Status:
COMPLETED
Last Update Posted:
2025-09-02
First Post:
2025-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Green Tea Extract and Ginger
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013662', 'term': 'Tea'}, {'id': 'C000713927', 'term': 'ginger extract'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2025-08-25', 'studyFirstSubmitQcDate': '2025-08-25', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Exhaustion (TTE)', 'timeFrame': 'Immediately during each exercise test session (after supplement ingestion, under normal and cold environmental conditions)', 'description': 'Endurance performance assessed as the total time in seconds participants are able to maintain cycling at 70% of VO₂max on a cycle ergometer, until volitional exhaustion defined as the inability to sustain a cadence of 60 rpm for 10 consecutive seconds'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nutritional Supplementation', 'Exercise Physiology']}, 'referencesModule': {'references': [{'pmid': '41010475', 'type': 'DERIVED', 'citation': 'Demirli A, Ulupinar S, Terzi M, Ozbay S, Ozkara AB, Gencoglu C, Ouergui I, Ardigo LP. Synergistic Effects of Green Tea Extract and Ginger Supplementation on Endurance Performance and Thermal Perception in Normothermic and Cold Environments: A Randomized, Placebo-Controlled, Double-Blind Crossover Trial. Nutrients. 2025 Sep 13;17(18):2949. doi: 10.3390/nu17182949.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the effects of green tea extract and ginger supplementation, both individually and in combination, on endurance performance, metabolism, thermal comfort, and muscle soreness in recreationally active young men. Participants will complete cycling tests under both normal room temperature (21-24°C) and cold (5-7°C) conditions. The study uses a randomized, double-blind, placebo-controlled, crossover design to compare the outcomes of placebo, green tea, ginger, and combined supplementation. The findings may help to identify nutritional strategies that improve exercise performance and comfort in different environmental conditions.', 'detailedDescription': 'This randomized, double-blind, placebo-controlled, crossover trial is designed to evaluate the effects of green tea extract and ginger supplementation, both individually and in combination, on endurance performance, metabolic responses, thermal sensation, and muscle soreness in recreationally active men.\n\nSixteen healthy participants will complete eight experimental conditions: placebo, green tea extract (500 mg), ginger (1 g), and a combination of both, tested under normal (21-24°C) and cold (5-7°C) environments. Each condition will be separated by a washout period to avoid carryover effects.\n\nEndurance capacity will be measured using a time-to-exhaustion cycling test at 70% of maximal oxygen uptake (VO₂max). Metabolic responses will be assessed by gas analysis to determine respiratory exchange ratio (RER). Perceptual measures will include the Borg Rating of Perceived Exertion (RPE) and a thermal sensation scale, while muscle soreness will be evaluated 24 hours post-exercise using a visual analog scale (VAS).\n\nThe study aims to determine whether the combined intake of green tea and ginger provides synergistic benefits over individual supplementation, particularly in cold environments where thermoregulation and endurance capacity are challenged. Findings may contribute to practical nutritional strategies that enhance exercise performance, comfort, and recovery under environmental stress conditions.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale participants aged 18-35 years\n\nRecreationally active (≥3 aerobic exercise sessions per week, ≥30 minutes per session, for at least 6 months)\n\nVO₂max between 40-50 mL/kg/min (recreationally active fitness level)\n\nBody mass index within the normal to slightly overweight range (approximately 18.5-27.5 kg/m²)\n\nWillingness to comply with study requirements, including supplementation and exercise testing protocols\n\nProvided written informed consent\n\nExclusion Criteria:\n\nHistory of cardiovascular, respiratory, metabolic, or neurological disorders\n\nAllergy or intolerance to green tea, ginger, or maltodextrin\n\nCurrent use of ergogenic supplements, medications affecting metabolism, or stimulants (e.g., beta-blockers, caffeine pills)\n\nSmoking or excessive alcohol consumption (\\>14 units per week)\n\nInconsistent exercise habits (\\<3 sessions/week in the past 6 months)\n\nParticipation in another clinical trial within the past 3 months'}, 'identificationModule': {'nctId': 'NCT07150533', 'acronym': 'Thermal effect', 'briefTitle': 'Green Tea Extract and Ginger', 'organization': {'class': 'OTHER', 'fullName': 'Erzurum Technical University'}, 'officialTitle': 'Synergistic Effects of Green Tea Extract and Ginger Supplementation on Endurance Performance and Thermal Perception in Normal and Cold Environments: A Randomized Crossover Trial', 'orgStudyIdInfo': {'id': 'ETU-Green Tea and Ginger'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'description': 'Participants receive a placebo consisting of maltodextrin in capsule form, matched in appearance and taste to the active supplements.', 'interventionNames': ['Dietary Supplement: Placebo Arm']}, {'type': 'EXPERIMENTAL', 'label': 'Green Tea Extract Arm', 'description': 'Participants receive 500 mg of standardized green tea extract in capsule form.', 'interventionNames': ['Dietary Supplement: Green Tea Extract']}, {'type': 'EXPERIMENTAL', 'label': 'Ginger Arm', 'description': 'Participants receive 1 g of ginger supplement in capsule form.', 'interventionNames': ['Dietary Supplement: Ginger']}, {'type': 'EXPERIMENTAL', 'label': 'Combined Supplement Arm', 'description': 'Participants receive a combination of 500 mg green tea extract and 1 g ginger, both administered in capsule form.', 'interventionNames': ['Dietary Supplement: Combined Supplement (Green Tea + Ginger)']}], 'interventions': [{'name': 'Placebo Arm', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants receive a placebo consisting of maltodextrin in capsule form, matched in appearance and taste to the active supplements.', 'armGroupLabels': ['Placebo Arm']}, {'name': 'Green Tea Extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants receive 500 mg of standardized green tea extract in capsule form.', 'armGroupLabels': ['Green Tea Extract Arm']}, {'name': 'Ginger', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants receive 1 g of ginger supplement in capsule form.', 'armGroupLabels': ['Ginger Arm']}, {'name': 'Combined Supplement (Green Tea + Ginger)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants receive a combination of 500 mg green tea extract and 1 g ginger, both administered in capsule form.', 'armGroupLabels': ['Combined Supplement Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25240', 'city': 'Erzurum', 'state': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Erzurum Technical University Sport Sciences Faculty', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erzurum Technical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Exercise Physiology', 'investigatorFullName': 'Süleyman Ulupınar', 'investigatorAffiliation': 'Erzurum Technical University'}}}}