Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT06712667
Status:
RECRUITING
Last Update Posted:
2025-02-26
First Post:
2024-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Coffee on People with High Intensity Exercise and the Characteristics of Caffeine Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2024-11-26', 'studyFirstSubmitQcDate': '2024-11-26', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise performance', 'timeFrame': 'On the experimental day, it lasts 2 weeks.', 'description': 'After the completion of the riding, the subjects perceived and judged the perception between the baseline load and the comparison load.'}, {'measure': 'Urine metabolites', 'timeFrame': 'On the experimental day, it lasts 2 weeks.', 'description': 'The contents of metabolites will be measured by gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS ).'}], 'secondaryOutcomes': [{'measure': 'Body temperature', 'timeFrame': 'On the experimental day, it lasts 2 weeks.', 'description': 'Body temperature of participants will be measured by ear temperature gun.'}, {'measure': 'Electrocardiogram (ECG)', 'timeFrame': 'On the experimental day, it lasts 2 weeks.', 'description': 'ECG of participants will be measured by Amu ECG belt, the changes in P wave, PR interval, PR segment, QRS wave group, J point, ST segment, T wave, QT interval, and U wave will be observe.'}, {'measure': 'Blood pressure', 'timeFrame': 'On the experimental day, it lasts 2 weeks.', 'description': 'Systolic and diastolic blood pressure of participants will be measured by Omron digital sphygmomanometer.'}, {'measure': 'Height', 'timeFrame': 'The morning of the first day of the experiment, 5 mins', 'description': 'Height will be measured by seca 217 stable stadiometer. Subjects wearing no shoes.'}, {'measure': 'Body weight', 'timeFrame': 'The morning of the first day of the experiment, 5 mins', 'description': 'Fasting body weight will be measured by Bioimpedance Analysis (TANITA, MC-980).'}, {'measure': 'Fat mass', 'timeFrame': 'The morning of the first day of the experiment, 10 mins', 'description': 'Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ).'}, {'measure': 'Fat free mass', 'timeFrame': 'The morning of the first day of the experiment, 10 mins', 'description': 'Fat free mass will be measured by Bioimpedance Analysis (Tanita, MC-980).'}, {'measure': 'Bone mass', 'timeFrame': 'The morning of the first day of the experiment, 10 mins', 'description': 'Bone mass will be measured by Dual Energy X-ray Absorptiometry (Horizon Wi).'}, {'measure': 'Heart rate', 'timeFrame': '2 weeks', 'description': 'Heart rate will be measured by heart rate belt.'}, {'measure': 'Waist circumferences', 'timeFrame': 'The morning of the first day of the experiment,10 mins', 'description': 'Waist circumferences will be measured using a whole body laser scanner (TG2000-F).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coffee', 'Caffeine', 'Exercise', 'Caffeine metabolism'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to explore the relationship between the effect of coffee on exercise performance and caffeine metabolism.', 'detailedDescription': 'The investigators will study the relationship between the impact of coffee on exercise and caffeine metabolism. The investigators will recruit healthy elite athletes. Participants will be forbidden to consume stimulant drinks such as coffee for 24 hours before the experiment. When the participants arrive at the lab on the day of the experiment, they will sign an informed consent form, a health history questionnaire and a daily coffee consumption questionnaire. Each participant does six rides, with one day of caffeine washout before each ride. In all trials, each participant will ride at the same time of day. Before riding, drink 200 ml water, decaffeinated coffee or coffee in random order, and the caffeine content of coffee is 200 mg. After 60 minutes of drinking, they start riding, after the completion of the riding, the subjects perceived and judged the perception between the baseline load and the comparison load. After the completion of the judgment, the next level of stimulus parameters will randomly generated to conduct the experiment. Each person conducted 6 groups of intervention experiments. Changes in average exercise performance, heart rate, electrocardiogram and body temperature will be observed after drinking decaffeinated coffee or coffee compared with drinking water. The concentration of caffeine and its metabolites in urine before and after drinking within 3 hours will be measured by liquid chromatography-mass spectrometry (LC-MS) or gas chromatography-mass spectrometry (GC-MS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy adults 18-40 years old\n\nExclusion Criteria:\n\nDiabetes Hypoglycemia Gout Osteoporosis Gastric ulcer Pancreatitis Intestinal obstruction Blood phobia Pathological hypo or hyper tension Impaired glucose tolerance Claustrophobia HIV,etc.'}, 'identificationModule': {'nctId': 'NCT06712667', 'briefTitle': 'The Effect of Coffee on People with High Intensity Exercise and the Characteristics of Caffeine Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences'}, 'officialTitle': 'The Effect of Coffee on People with High Intensity Exercise and the Characteristics of Caffeine Metabolism', 'orgStudyIdInfo': {'id': 'SIAT IRB240915H0915'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Water', 'description': 'The participants will drink 200 ml water.', 'interventionNames': ['Other: Caffeine content']}, {'type': 'EXPERIMENTAL', 'label': 'Decaffeinated coffee', 'description': 'The participants will drink 200 ml decaffeinated coffee.', 'interventionNames': ['Other: Caffeine content']}, {'type': 'EXPERIMENTAL', 'label': 'Coffee', 'description': 'The participants will drink 200 ml coffee, the caffeine content is 200 mg.', 'interventionNames': ['Other: Caffeine content']}], 'interventions': [{'name': 'Caffeine content', 'type': 'OTHER', 'description': 'Participants will drink the same volume of water or coffee with different amounts of caffeine.', 'armGroupLabels': ['Coffee', 'Decaffeinated coffee', 'Water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '518055', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huanan Zhang, Master', 'role': 'CONTACT', 'email': 'hnzhang2021@163.com', 'phone': '13371016641'}], 'facility': 'Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'centralContacts': [{'name': 'John R Speakman, PhD', 'role': 'CONTACT', 'email': 'j.speakman@abdn.ac.uk', 'phone': '15810868669'}, {'name': 'Huanan Zhang, Master', 'role': 'CONTACT', 'email': 'hnzhang2021@163.com', 'phone': '13371016641'}], 'overallOfficials': [{'name': 'John R Speakman, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'John R. Speakman', 'investigatorAffiliation': 'Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences'}}}}