Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-24 @ 11:01 AM
Study NCT ID:
NCT01651793
Status:
COMPLETED
Last Update Posted:
2018-06-25
First Post:
2012-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Phytochemicals From Theobroma Cacao on Mental Energy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005222', 'term': 'Mental Fatigue'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069956', 'term': 'Chocolate'}, {'id': 'D002110', 'term': 'Caffeine'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'poconnor@uga.edu', 'phone': '706-542-4382', 'title': "Dr. Patrick J. O'Connor", 'organization': 'University of Georgia'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Recruitment targeted those reporting low consumption of fruits and vegetables and other foods containing flavonols; not all participants were medication-free; the potential role of sensory aspects of cocoa were not examined.'}}, 'adverseEventsModule': {'timeFrame': 'The study personnel monitored participants through study completion, an average of 4 weeks, for adverse events. No adverse events were reported to study personnel.', 'eventGroups': [{'id': 'EG000', 'title': 'Caffeinated Cocoa', 'description': 'High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle\n\nActive comparator 1: High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cocoa', 'description': 'High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle\n\nActive comparator 2: High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cafeine', 'description': 'Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle\n\nActive comparator 4: Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle\n\nInactive comparator: No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Correct Responses on Serial 7 Subtraction Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-test', 'description': 'Baseline measures, pre consumption of beverages.'}, {'id': 'OG001', 'title': 'Post-test 1', 'description': '21-47 minutes post consumption.'}, {'id': 'OG002', 'title': 'Post-test 2', 'description': '57-83 minutes post consumption.'}, {'id': 'OG003', 'title': 'Post-test 3', 'description': '93-119 minutes post consumption.'}], 'classes': [{'title': 'Subtract 7 Correct - Placebo', 'categories': [{'measurements': [{'value': '40.91', 'spread': '5.56', 'groupId': 'OG000'}, {'value': '42.57', 'spread': '3.51', 'groupId': 'OG001'}, {'value': '43.04', 'spread': '2.31', 'groupId': 'OG002'}, {'value': '42.13', 'spread': '3.67', 'groupId': 'OG003'}]}]}, {'title': 'Subtract 7 Correct - Caffeine', 'categories': [{'measurements': [{'value': '41.83', 'spread': '3.56', 'groupId': 'OG000'}, {'value': '41.35', 'spread': '3.73', 'groupId': 'OG001'}, {'value': '43.22', 'spread': '2.92', 'groupId': 'OG002'}, {'value': '42.74', 'spread': '3.03', 'groupId': 'OG003'}]}]}, {'title': 'Subtract 7 Correct - Cocoa', 'categories': [{'measurements': [{'value': '42.57', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '42.61', 'spread': '3.86', 'groupId': 'OG001'}, {'value': '42.78', 'spread': '3.06', 'groupId': 'OG002'}, {'value': '42.61', 'spread': '3.81', 'groupId': 'OG003'}]}]}, {'title': 'Subtract 7 Correct - Caffeine + Cocoa', 'categories': [{'measurements': [{'value': '42.17', 'spread': '3.24', 'groupId': 'OG000'}, {'value': '42.26', 'spread': '2.47', 'groupId': 'OG001'}, {'value': '42.96', 'spread': '2.33', 'groupId': 'OG002'}, {'value': '43.14', 'spread': '2.88', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000'], 'pValueComment': 'P value reference to the beverage x time interaction effect', 'groupDescription': "Hypotheses were tested using a series (all outcome variables) of 2 Treatment x 4 Time point, repeated measures ANCOVAs that controlled for the prior night's sleep. Primary interests were the presence of statistically significant interactions of time and either cocoa versus placebo, cocoa + caffeine versus cocoa, or cocoa + caffeine versus caffeine-only. Significant interactions were decomposed using one-way ANOVAs and t-tests with familywise error controlled using LSD post-hoc tests.", 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre and 30, 60 and 120 minutes post intervention', 'description': 'Participants subtract the number 7 from a three digit number and quickly and accurately as possible for 60 seconds. The total number of accurate responses is scored. The higher the score the better performance. The range of scores is from a minimum score of 0 to a theoretical maximum score of 120.', 'unitOfMeasure': 'Correct responses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Performance on Bakan Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-test', 'description': 'Baseline measures, pre consumption of beverages.'}, {'id': 'OG001', 'title': 'Post-test 1', 'description': '21-47 minutes post consumption.'}, {'id': 'OG002', 'title': 'Post-test 2', 'description': '57-83 minutes post consumption.'}, {'id': 'OG003', 'title': 'Post-test 3', 'description': '93-119 minutes post consumption.'}], 'classes': [{'title': 'Bakan Primary Correct - Placebo', 'categories': [{'measurements': [{'value': '6.35', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '6.00', 'spread': '1.57', 'groupId': 'OG001'}, {'value': '5.96', 'spread': '2.01', 'groupId': 'OG002'}, {'value': '6.09', 'spread': '1.95', 'groupId': 'OG003'}]}]}, {'title': 'Bakan Primary Correct - Caffeine', 'categories': [{'measurements': [{'value': '6.35', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '6.57', 'spread': '1.78', 'groupId': 'OG001'}, {'value': '6.87', 'spread': '1.39', 'groupId': 'OG002'}, {'value': '6.13', 'spread': '1.36', 'groupId': 'OG003'}]}]}, {'title': 'Bakan Primary Correct - Cocoa', 'categories': [{'measurements': [{'value': '6.43', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '6.52', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '6.30', 'spread': '1.11', 'groupId': 'OG002'}, {'value': '5.78', 'spread': '1.70', 'groupId': 'OG003'}]}]}, {'title': 'Bakan Primary Correct - Caffeine + Cocoa', 'categories': [{'measurements': [{'value': '5.83', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '6.13', 'spread': '1.77', 'groupId': 'OG001'}, {'value': '6.35', 'spread': '1.77', 'groupId': 'OG002'}, {'value': '6.61', 'spread': '1.47', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, post 60, post 90, post 120', 'description': 'Performance on Bakan Task at baseline, post-test 1, post-test 2, and post-test 3\n\nBakan test presents numbers on a computer screen. Participant presses one button whenever the number 6 appears and a different button whenever three odd and different numbers in a row occurs such as 7 5 9. The number of times the participant does this correctly the better the performance. The scores range from 0 to 10 because the sequence of three odd and different numbers occurs a total of 10 times.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vigor Symptoms (Profile of Mood State)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-test', 'description': 'Mood measure at baseline.'}, {'id': 'OG001', 'title': 'Post-test 1', 'description': '22-48 minutes post consumption.'}, {'id': 'OG002', 'title': 'Post-test 2', 'description': '60-86 minutes post consumption.'}, {'id': 'OG003', 'title': 'Post-test 3', 'description': '98-124 minutes post consumption.'}], 'classes': [{'title': 'POMS Vigor - Placebo', 'categories': [{'measurements': [{'value': '3.78', 'spread': '4.36', 'groupId': 'OG000'}, {'value': '3.57', 'spread': '4.00', 'groupId': 'OG001'}, {'value': '3.52', 'spread': '3.44', 'groupId': 'OG002'}, {'value': '3.65', 'spread': '3.68', 'groupId': 'OG003'}]}]}, {'title': 'POMS Vigor - Caffeine', 'categories': [{'measurements': [{'value': '3.91', 'spread': '3.66', 'groupId': 'OG000'}, {'value': '3.91', 'spread': '3.99', 'groupId': 'OG001'}, {'value': '4.00', 'spread': '3.92', 'groupId': 'OG002'}, {'value': '4.26', 'spread': '3.29', 'groupId': 'OG003'}]}]}, {'title': 'POMS Vigor - Cocoa', 'categories': [{'measurements': [{'value': '3.65', 'spread': '4.01', 'groupId': 'OG000'}, {'value': '3.74', 'spread': '3.45', 'groupId': 'OG001'}, {'value': '4.00', 'spread': '3.84', 'groupId': 'OG002'}, {'value': '3.70', 'spread': '3.30', 'groupId': 'OG003'}]}]}, {'title': 'POMS Vigor - Caffeinated Cocoa', 'categories': [{'measurements': [{'value': '4.09', 'spread': '4.43', 'groupId': 'OG000'}, {'value': '4.48', 'spread': '4.28', 'groupId': 'OG001'}, {'value': '4.04', 'spread': '4.03', 'groupId': 'OG002'}, {'value': '4.17', 'spread': '3.87', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre and 90, 120 and 160 minutes post intervention', 'description': 'Vigor subscale scores from the Profile of Mood States.The higher the score the greater the feelings of energy. The scores range from a minimum of 0 to a maximum of 20.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Caffeinated Cocoa, Cocoa, Caffeine, Placebo', 'description': 'Order: Caffeinated cocoa, cocoa, caffeine, Placebo; 6 participants were randomized to this order.'}, {'id': 'FG001', 'title': 'Cocoa, Caffeine, Placebo, Caffeinated Cocoa', 'description': 'Order: Cocoa, Caffeine, Placebo, Caffeinated Cocoa; 6 participants were randomize to receive treatment in this order.'}, {'id': 'FG002', 'title': 'Caffeine, Placebo, Caffeinated Cocoa, Cocoa', 'description': 'Order: Caffeine, Placebo, Caffeinated cocoa, Cocoa; 6 participants were randomized to receive treatment in this order.'}, {'id': 'FG003', 'title': 'Placebo, Caffeinated Cocoa, Cocoa, Caffeine', 'description': 'Order: Placebo, Caffeinated cocoa, Cocoa, Caffeine; 6 participants were randomized to receive treatment in this order.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Potential participants were recruited from (i) large university classes, (ii) announcements on buses, bulletin boards, and electronic listservs, and (iii) through word of mouth. Potential participants were invited to complete screening questionnaires (medical history, diet, mood) administered online using Zoomerang\n\n\\>http://www.zoomerang.com/\\<.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Completed Participants', 'description': 'These baseline data represent all participants who completed the trial (n = 23). Data are presented as means and standard deviations where appropriate.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20', 'spread': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Amount of sleep on a typical night in the past month (hrs)', 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '1.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'hours', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '168.28', 'spread': '1.19', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '67.05', 'spread': '14.87', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-20', 'studyFirstSubmitDate': '2012-07-25', 'resultsFirstSubmitDate': '2017-01-19', 'studyFirstSubmitQcDate': '2012-07-26', 'lastUpdatePostDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-20', 'studyFirstPostDateStruct': {'date': '2012-07-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correct Responses on Serial 7 Subtraction Task', 'timeFrame': 'Pre and 30, 60 and 120 minutes post intervention', 'description': 'Participants subtract the number 7 from a three digit number and quickly and accurately as possible for 60 seconds. The total number of accurate responses is scored. The higher the score the better performance. The range of scores is from a minimum score of 0 to a theoretical maximum score of 120.'}, {'measure': 'Performance on Bakan Task', 'timeFrame': 'baseline, post 60, post 90, post 120', 'description': 'Performance on Bakan Task at baseline, post-test 1, post-test 2, and post-test 3\n\nBakan test presents numbers on a computer screen. Participant presses one button whenever the number 6 appears and a different button whenever three odd and different numbers in a row occurs such as 7 5 9. The number of times the participant does this correctly the better the performance. The scores range from 0 to 10 because the sequence of three odd and different numbers occurs a total of 10 times.'}], 'secondaryOutcomes': [{'measure': 'Vigor Symptoms (Profile of Mood State)', 'timeFrame': 'Pre and 90, 120 and 160 minutes post intervention', 'description': 'Vigor subscale scores from the Profile of Mood States.The higher the score the greater the feelings of energy. The scores range from a minimum of 0 to a maximum of 20.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cacao', 'theobromine', 'flavanols', 'caffeine', 'sustained attention', 'vigilance', 'vigor', 'vitality', 'energy', 'fatigue'], 'conditions': ['Mental Fatigue']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine which substances in cocoa produces changes in mental energy. This is a double blind study. The primary outcome measures are performance on tasks of sustained attention (serial subtract, continuous performance test and Bakan task) at pre and 90, 120 and 160 minutes post intervention, energy and fatigue symptoms (profile of mood state), and ratings of motivation to perform cognitive tasks. The assigned interventions are the following:', 'detailedDescription': 'Only one prior study has examined the acute influence of cocoa on mental energy. The purpose of this research is to replicate the previous observations and extend research in four ways: 1) start to determine which substance in cocoa responsible for the effect by including several comparison groups, 2) focus on individuals with average or below average symptoms of mental energy and who are not high consumers of fruits, vegetables and other products containing high amounts of flavonoids in order to learn whether people with low energy accrue a greater benefit, and 3) include additional measures of mental energy plausibly influenced by cocoa to better understand the health consequences of cocoa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '34 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women and men ages 18-34\n* Lower than average feelings of energy (score of \\< 13 on Profile of Mood States Vigor scale)\n\nExclusion Criteria:\n\n* Pregnant\n* GI tract disorder\n* Psychoactive medication use\n* Daily consumption of \\> 200 mg caffeine\n* Body mass index \\> 30\n* Cigarette smoker\n* Allergy to cocoa, chocolate or caffeine\n* Frequent consumption of cocoa, chocolate-based products or fruits and vegetable containing flavonoids'}, 'identificationModule': {'nctId': 'NCT01651793', 'briefTitle': 'Effect of Phytochemicals From Theobroma Cacao on Mental Energy', 'organization': {'class': 'OTHER', 'fullName': 'University of Georgia'}, 'officialTitle': 'Effect of Phytochemicals From Theobroma Cacao on Mental Energy', 'orgStudyIdInfo': {'id': 'Study of cocoa-like beverages'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Caffeinated cocoa', 'description': 'High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle', 'interventionNames': ['Other: Caffeinated cocoa']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cocoa', 'description': 'High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle', 'interventionNames': ['Other: Cocoa']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Caffeine', 'description': 'Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle', 'interventionNames': ['Other: Caffeine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Caffeinated cocoa', 'type': 'OTHER', 'description': '70 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener', 'armGroupLabels': ['Caffeinated cocoa']}, {'name': 'Cocoa', 'type': 'OTHER', 'description': '21 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener', 'armGroupLabels': ['Cocoa']}, {'name': 'Caffeine', 'type': 'OTHER', 'description': '473 ml brewed water containing 66 mg caffeine, caramel coloring and one packet Truvia sweetener', 'armGroupLabels': ['Caffeine']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '473 ml of brewed water, caramel coloring and one packet Truvia sweetener', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30602', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'University of Georgia', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}], 'overallOfficials': [{'name': "Patrick O'Connor, PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Georgia'}]}, 'ipdSharingStatementModule': {'timeFrame': 'January 1, 2019', 'ipdSharing': 'YES', 'description': "IPD will be kept securely at the University of Georgia for several years and can be accessed upon request by contacting Dr. Pat O'Connor (poconnor@uga.edu).", 'accessCriteria': 'Open Access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Georgia', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Hershey Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Kinesiology', 'investigatorFullName': "Patrick O'Connor", 'investigatorAffiliation': 'University of Georgia'}}}}