Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT05547204
Status:
COMPLETED
Last Update Posted:
2023-03-16
First Post:
2022-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Coffeeberry Extract on Skill Performance During Simulated Match Play in Academy Football Players
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001628', 'term': 'Beverages'}], 'ancestors': [{'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-15', 'studyFirstSubmitDate': '2022-09-13', 'studyFirstSubmitQcDate': '2022-09-13', 'lastUpdatePostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dribbling speed', 'timeFrame': 'Change from pre-dose baseline through end of match 3.5 hours post consumption at multiple intervals each half of match', 'description': 'm/sec, increase would be better. Simulated soccer match in an indoor gym with pre-set targets.'}, {'measure': 'Dribbling precision', 'timeFrame': 'Change from pre-dose baseline through end of match 3.5 hours post consumption at multiple intervals each half of match', 'description': 'Meters, more accuracy would be better. Simulated soccer match in an indoor gym with pre-set targets.'}, {'measure': 'Passing accuracy', 'timeFrame': 'Change from pre-dose baseline through end of match 3.5 hours post consumption at multiple intervals each half of match.', 'description': '1 to 10 scale, a higher score would be better. Simulated soccer match in an indoor gym with pre-set targets.'}, {'measure': 'Passing speed', 'timeFrame': 'Change from pre-dose baseline through end of match 3.5 hours post consumption at multiple intervals each half of match', 'description': 'km/h, increased passing speed would be better. Simulated soccer match in an indoor gym with pre-set targets.'}, {'measure': 'Sprint speed.', 'timeFrame': 'Change from pre-dose baseline through end of match 3.5 hours post consumption at multiple intervals each half of match', 'description': 'm/sec, increased sprint speed would be better. In indoor gym with marked course.'}], 'secondaryOutcomes': [{'measure': 'Blood analyte: Chlorogenic acid (CGA)', 'timeFrame': 'Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)', 'description': 'mmol/L to evaluate primary outcomes. n.a. for placebo. Capillary blood draw for frozen plasma analysis'}, {'measure': 'Blood analyte: Caffeine metabolites', 'timeFrame': 'Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)', 'description': 'ug/ml, to evaluate primary outcomes. n.a. for placebo. Capillary blood draw for frozen plasma analysis'}, {'measure': 'Blood analyte: Glucose', 'timeFrame': 'Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)', 'description': 'mmol/L, more regulated would be better. Capillary blood draw for frozen plasma analysis'}, {'measure': 'Blood analyte: Lactate', 'timeFrame': 'Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)', 'description': 'mmol/L, lower (delayed rise) would be better. Capillary blood draw for frozen plasma analysis'}, {'measure': 'Rating of perceived exertion (RPE)', 'timeFrame': 'Half-time and end of match (3.5 hours)', 'description': 'By Borg scale, rated 6 to 20, very very light to very very hard. Lower values would be better'}, {'measure': 'Activation-deactivation (feelings or mood)', 'timeFrame': 'Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)', 'description': "Checklist of 20 feelings using a 4 point scale from definitely do feel to definitely don't feel. More relaxed feelings or in a better mood would be better."}, {'measure': 'Mental energy', 'timeFrame': 'Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)', 'description': 'Visual Analog Scale (VAS), vertical marking on 100 mm horizontal line. Higher energy would be better'}, {'measure': 'Physical energy', 'timeFrame': 'Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)', 'description': 'Visual Analog Scale (VAS), vertical marking on 100 mm horizontal line. Higher energy would be better'}, {'measure': 'Gut comfort', 'timeFrame': 'Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)', 'description': 'Visual Analog Scale (VAS), vertical marking on 100 mm horizontal line. No or less nausea, fullness or bloating would be better'}, {'measure': 'Heart rate', 'timeFrame': 'Continuous from pre-dose baseline through end of match (3.5 hours)', 'description': 'By electronic reading. Lower would be better.'}, {'measure': 'Hydration status', 'timeFrame': 'Pre-dose baseline and end of match (3.5 hours)', 'description': 'Urine osmolality in mOsm/kg change in concentration pre- vs. post-exercise'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coffeeberry', 'caffeine', 'polyphenols', 'chlorogenic acid', 'exercise', 'soccer', 'football', 'skill', 'performance'], 'conditions': ['Skill Performance', 'Soccer Performance', 'Coffeeberry Effects']}, 'descriptionModule': {'briefSummary': 'This study of soccer skill performance has three objectives:\n\n1. Compare effects of coffeeberry (300mg) and placebo ingestion on dribbling speed and precision, passing speed and accuracy, and sprint speed during a full simulated soccer match.\n2. Compare effects of coffeeberry (300mg) and placebo ingestion on subjective measures (mental / physical energy and activation-deactivation (feelings or mood) during a full simulated soccer match.\n3. Compare effects of coffeeberry (300mg) and placebo ingestion on chlorogenic acid (CGA) and caffeine metabolites in the blood 1-hour post ingestion, and other blood metabolites (glucose/lactate) throughout the simulated soccer match.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '28 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide valid informed consent prior to any study procedure\n* Male soccer players age 16 to 28 years.\n* \\>= 5-year soccer playing experience\n* \\>= 1-year regularly soccer training\n* Free of injuries\n* Willing to avoid alcohol in the 48-h period prior to all visits\n* Willing to avoid caffeinated products and apples, berries/cherries for 24-h prior to all visits\n* Willing to record food intake over the 48-h period prior to the first trial and replicate for second trial\n* Willing to abstain from strenuous physical activity for 24-h before all visits\n\nExclusion Criteria:\n\n* Smoking\n* Cardiovascular diseases\n* Diabetes or other metabolic disease • Hypertension (\\>140/\\>90 mm Hg)\n* Presence of injuries\n* Major illnesses or surgery in prior 90 days\n* Participation in another clinical trial in the past month'}, 'identificationModule': {'nctId': 'NCT05547204', 'briefTitle': 'Impact of Coffeeberry Extract on Skill Performance During Simulated Match Play in Academy Football Players', 'organization': {'class': 'INDUSTRY', 'fullName': 'PepsiCo Global R&D'}, 'officialTitle': 'Impact of Coffeeberry Extract on Skill Performance During Simulated Match Play in Academy Football Players', 'orgStudyIdInfo': {'id': 'PEP-2114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Coffeeberry beverage', 'description': '300 ml drink containing 300 mg coffeeberry extract', 'interventionNames': ['Other: Beverage']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Color and flavor matched beverage', 'description': '300 ml drink (0 mg coffeeberry extract, 0 mg caffeine)', 'interventionNames': ['Other: Beverage']}], 'interventions': [{'name': 'Beverage', 'type': 'OTHER', 'description': 'Free from added carbohydrates (contain 1g CHO only) and electrolytes are absent.', 'armGroupLabels': ['Coffeeberry beverage', 'Color and flavor matched beverage']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'FK9 4LA', 'city': 'Stirling', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'U. Stirling, Health Science and Sport', 'geoPoint': {'lat': 56.11903, 'lon': -3.93682}}], 'overallOfficials': [{'name': 'Stuart Galloway, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'U. Stirling, Scotland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PepsiCo Global R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}