Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 10:44 AM
Study NCT ID:
NCT05216406
Status:
COMPLETED
Last Update Posted:
2025-02-12
First Post:
2021-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Daily Supplementation of 5-HTP on Body Composition
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006916', 'term': '5-Hydroxytryptophan'}], 'ancestors': [{'id': 'D014364', 'term': 'Tryptophan'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jose.Antonio@nova.edu', 'phone': '(954) 262-8140', 'title': 'Dr. Jose Antonio', 'organization': 'Nova Southeastern University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The primary limitation of this study was the lack of control for exercise. Although subjects were instructed to maintain the same training habits, it is certainly possible that training changed.'}}, 'adverseEventsModule': {'timeFrame': '1 day', 'description': 'Self-report at the end of the trial.', 'eventGroups': [{'id': 'EG000', 'title': '5-HTP', 'description': 'The dietary supplement (100 mg of 5-hydroxytryptophan; CLEANMOOD™) was provided by NURA™ (Irvine, California USA). Subjects were instructed to consume one capsule daily at their convenience for 8 weeks.\n\n5-HTP: CLEANMOOD is an organic 5-Hydroxytryptophan (5-HTP) ingredient.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 3, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'The placebo consisted of maltodextrin. Subjects were instructed to consume one capsule daily at their convenience for 8 weeks.\n\nPlacebo: Maltodextrin capsule', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 2, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upset Stomach', 'notes': 'a disorder of digestive function characterized by discomfort or heartburn or nausea. dyspepsia, indigestion, stomach upset', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Body Composition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-HTP', 'description': 'The dietary supplement (100 mg of 5-hydroxytryptophan; CLEANMOOD™) was provided by NURA™ (Irvine, California USA). Subjects were instructed to consume one capsule daily at their convenience for 8 weeks.\n\n5-HTP: CLEANMOOD is an organic 5-Hydroxytryptophan (5-HTP) ingredient.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The placebo consisted of maltodextrin. Subjects were instructed to consume one capsule daily at their convenience for 8 weeks.\n\nPlacebo: Maltodextrin capsule'}], 'classes': [{'title': 'Fat Mass', 'categories': [{'measurements': [{'value': '14.6', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '4.4', 'groupId': 'OG001'}]}]}, {'title': 'Lean Body Mass', 'categories': [{'measurements': [{'value': '58.4', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '57.7', 'spread': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'Body Mass', 'categories': [{'measurements': [{'value': '73', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '70.2', 'spread': '12.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'The percentage of fat, bone, and muscle was assessed pre and post visit using multi-frequency bioelectrical impedance device (InBody® 270).', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dietary Habits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-HTP', 'description': 'The dietary supplement (100 mg of 5-hydroxytryptophan; CLEANMOOD™) was provided by NURA™ (Irvine, California USA). Subjects were instructed to consume one capsule daily at their convenience for 8 weeks.\n\n5-HTP: CLEANMOOD is an organic 5-Hydroxytryptophan (5-HTP) ingredient.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The placebo consisted of maltodextrin. Subjects were instructed to consume one capsule daily at their convenience for 8 weeks.\n\nPlacebo: Maltodextrin capsule'}], 'classes': [{'title': 'Total Intake', 'categories': [{'measurements': [{'value': '1810', 'spread': '650', 'groupId': 'OG000'}, {'value': '1966', 'spread': '826', 'groupId': 'OG001'}]}]}, {'title': 'Fat', 'categories': [{'measurements': [{'value': '576', 'spread': '198', 'groupId': 'OG000'}, {'value': '684', 'spread': '387', 'groupId': 'OG001'}]}]}, {'title': 'Carbohydrate', 'categories': [{'measurements': [{'value': '796', 'spread': '364', 'groupId': 'OG000'}, {'value': '816', 'spread': '392', 'groupId': 'OG001'}]}]}, {'title': 'Protein', 'categories': [{'measurements': [{'value': '440', 'spread': '140', 'groupId': 'OG000'}, {'value': '464', 'spread': '168', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'The mobile app MyFitnessPal was used to assess dietary intake. Subjects were instructed to log their food intake MyFitnessPal, for a minimum of 2-3 days per week during the entire study.', 'unitOfMeasure': 'calories', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-HTP', 'description': 'The dietary supplement (100 mg of 5-hydroxytryptophan; CLEANMOOD™) was provided by NURA™ (Irvine, California USA). Subjects were instructed to consume one capsule daily at their convenience for 8 weeks.\n\n5-HTP: CLEANMOOD is an organic 5-Hydroxytryptophan (5-HTP) ingredient.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The placebo consisted of maltodextrin. Subjects were instructed to consume one capsule daily at their convenience for 8 weeks.\n\nPlacebo: Maltodextrin capsule'}], 'classes': [{'title': 'Systolic', 'categories': [{'measurements': [{'value': '119', 'spread': '14', 'groupId': 'OG000'}, {'value': '117', 'spread': '16', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic', 'categories': [{'measurements': [{'value': '70', 'spread': '7', 'groupId': 'OG000'}, {'value': '67', 'spread': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Systolic and diastolic blood pressure will be measured during pre and post visit using an upper arm blood pressure monitor and cuff.', 'unitOfMeasure': 'mmHG', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Resting Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-HTP', 'description': 'The dietary supplement (100 mg of 5-hydroxytryptophan; CLEANMOOD™) was provided by NURA™ (Irvine, California USA). Subjects were instructed to consume one capsule daily at their convenience for 8 weeks.\n\n5-HTP: CLEANMOOD is an organic 5-Hydroxytryptophan (5-HTP) ingredient.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The placebo consisted of maltodextrin. Subjects were instructed to consume one capsule daily at their convenience for 8 weeks.\n\nPlacebo: Maltodextrin capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '10', 'groupId': 'OG000'}, {'value': '65', 'spread': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Resting heart rate will be measured pre and post visit using an upper arm blood pressure monitor and cuff.', 'unitOfMeasure': 'BPM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '5-HTP', 'description': 'The dietary supplement (100 mg of 5-hydroxytryptophan; CLEANMOOD™) was provided by NURA™ (Irvine, California USA). Subjects were instructed to consume one capsule daily at their convenience for 8 weeks.\n\n5-HTP: CLEANMOOD is an organic 5-Hydroxytryptophan (5-HTP) ingredient.'}, {'id': 'FG001', 'title': 'Control', 'description': 'The placebo consisted of maltodextrin. Subjects were instructed to consume one capsule daily at their convenience for 8 weeks.\n\nPlacebo: Maltodextrin capsule'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '5-HTP', 'description': 'The dietary supplement (100 mg of 5-hydroxytryptophan; CLEANMOOD™) was provided by NURA™ (Irvine, California USA). Subjects were instructed to consume one capsule daily at their convenience for 8 weeks.\n\n5-HTP: CLEANMOOD is an organic 5-Hydroxytryptophan (5-HTP) ingredient.'}, {'id': 'BG001', 'title': 'Control', 'description': 'The placebo consisted of maltodextrin. Subjects were instructed to consume one capsule daily at their convenience for 8 weeks.\n\nPlacebo: Maltodextrin capsule'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Body Composition', 'classes': [{'title': 'Fat Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15.3', 'spread': '6.0', 'groupId': 'BG000'}, {'value': '12.4', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '13.9', 'spread': '5.2', 'groupId': 'BG002'}]}]}, {'title': 'Lean Body Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '57.5', 'spread': '13.9', 'groupId': 'BG000'}, {'value': '57.5', 'spread': '13.7', 'groupId': 'BG001'}, {'value': '57.5', 'spread': '13.8', 'groupId': 'BG002'}]}]}, {'title': 'Body Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '72.9', 'spread': '13.4', 'groupId': 'BG000'}, {'value': '69.1', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '71', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Blood Pressure', 'classes': [{'title': 'Systolic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '118', 'spread': '14', 'groupId': 'BG000'}, {'value': '117', 'spread': '13', 'groupId': 'BG001'}, {'value': '117.5', 'spread': '13.5', 'groupId': 'BG002'}]}]}, {'title': 'Diastolic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '72', 'spread': '10', 'groupId': 'BG000'}, {'value': '70', 'spread': '6', 'groupId': 'BG001'}, {'value': '71', 'spread': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Resting Heart Rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '69', 'spread': '12', 'groupId': 'BG000'}, {'value': '70', 'spread': '13', 'groupId': 'BG001'}, {'value': '69.5', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Beats Per Minute (BPM)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Dietary Intake', 'classes': [{'title': 'Total Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1906', 'spread': '683', 'groupId': 'BG000'}, {'value': '2022', 'spread': '765', 'groupId': 'BG001'}, {'value': '1964', 'spread': '720', 'groupId': 'BG002'}]}]}, {'title': 'Fat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '603', 'spread': '288', 'groupId': 'BG000'}, {'value': '630', 'spread': '234', 'groupId': 'BG001'}, {'value': '616.5', 'spread': '261', 'groupId': 'BG002'}]}]}, {'title': 'Carbohydrate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '836', 'spread': '452', 'groupId': 'BG000'}, {'value': '840', 'spread': '424', 'groupId': 'BG001'}, {'value': '838', 'spread': '438', 'groupId': 'BG002'}]}]}, {'title': 'Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '468', 'spread': '172', 'groupId': 'BG000'}, {'value': '548', 'spread': '224', 'groupId': 'BG001'}, {'value': '508', 'spread': '198', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilocalories', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-03', 'size': 144494, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-11T10:31', 'hasProtocol': True}, {'date': '2020-12-31', 'size': 190587, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-12-07T06:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'All subjects and investigators were blinded.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study followed a placebo (PLA)-controlled, double-blind and parallel-group design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2021-12-07', 'resultsFirstSubmitDate': '2022-07-11', 'studyFirstSubmitQcDate': '2022-01-18', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-11', 'studyFirstPostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Composition', 'timeFrame': '8 weeks', 'description': 'The percentage of fat, bone, and muscle was assessed pre and post visit using multi-frequency bioelectrical impedance device (InBody® 270).'}], 'secondaryOutcomes': [{'measure': 'Dietary Habits', 'timeFrame': '8 weeks', 'description': 'The mobile app MyFitnessPal was used to assess dietary intake. Subjects were instructed to log their food intake MyFitnessPal, for a minimum of 2-3 days per week during the entire study.'}, {'measure': 'Blood Pressure', 'timeFrame': '8 weeks', 'description': 'Systolic and diastolic blood pressure will be measured during pre and post visit using an upper arm blood pressure monitor and cuff.'}, {'measure': 'Resting Heart Rate', 'timeFrame': '8 weeks', 'description': 'Resting heart rate will be measured pre and post visit using an upper arm blood pressure monitor and cuff.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Body Composition', '5-HTP'], 'conditions': ['Body Composition']}, 'referencesModule': {'references': [{'pmid': '33375373', 'type': 'BACKGROUND', 'citation': 'Maffei ME. 5-Hydroxytryptophan (5-HTP): Natural Occurrence, Analysis, Biosynthesis, Biotechnology, Physiology and Toxicology. Int J Mol Sci. 2020 Dec 26;22(1):181. doi: 10.3390/ijms22010181.'}, {'pmid': '31258047', 'type': 'BACKGROUND', 'citation': "Stamatakis E, Straker L, Hamer M, Gebel K. The 2018 Physical Activity Guidelines for Americans: What's New? Implications for Clinicians and the Public. J Orthop Sports Phys Ther. 2019 Jul;49(7):487-490. doi: 10.2519/jospt.2019.0609."}, {'pmid': '1722953', 'type': 'BACKGROUND', 'citation': 'Cangiano C, Ceci F, Cairella M, Cascino A, Del Ben M, Laviano A, Muscaritoli M, Rossi-Fanelli F. Effects of 5-hydroxytryptophan on eating behavior and adherence to dietary prescriptions in obese adult subjects. Adv Exp Med Biol. 1991;294:591-3. doi: 10.1007/978-1-4684-5952-4_73. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this investigation was to compare supplementation with 5-HTP to placebo on indices of body composition. A randomized trial compared a sample of 48 resistance-trained individuals taking either 100 mg of 5-hydroxytryptophan supplementation or a placebo.\n\nThe investigators tested anthropometric measurements using a multi-frequency bioelectrical impedance device (InBody® 270). The primary outcome (i.e., changes in anthropometric measurements) was assessed at the first visit (pre-test-) and post-test (8 weeks). Secondary outcomes include resting heart rate, blood pressure, and dietary intake.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy or free of disease\n* Minimum of 1 year of regular physical activity. Regular physical activity is defined by a minimum of 150 minutes of aerobic activity or performing muscle-strengthening exercises at least 2 days a week.\n\nExclusion Criteria:\n\n* Physically inactive\n* Regularly used sleep aids of any kind\n* Currently taking selective serotonin reuptake inhibitors (SSRIs) and/or 5-HTP containing supplements.'}, 'identificationModule': {'nctId': 'NCT05216406', 'briefTitle': 'Effects of Daily Supplementation of 5-HTP on Body Composition', 'organization': {'class': 'OTHER', 'fullName': 'Nova Southeastern University'}, 'officialTitle': 'Effects of Daily Supplementation of 5-HTP on Body Composition, a Randomized Investigation', 'orgStudyIdInfo': {'id': '102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5-HTP', 'description': 'The dietary supplement (100 mg of 5-hydroxytryptophan; CLEANMOOD™) was provided by NURA™ (Irvine, California USA). Subjects were instructed to consume one capsule daily at their convenience for 8 weeks.', 'interventionNames': ['Dietary Supplement: 5-HTP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'The placebo consisted of maltodextrin. Subjects were instructed to consume one capsule daily at their convenience for 8 weeks.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': '5-HTP', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['CLEANMOOD™'], 'description': 'CLEANMOOD is an organic 5-Hydroxytryptophan (5-HTP) ingredient.', 'armGroupLabels': ['5-HTP']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Control'], 'description': 'Maltodextrin capsule', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33432', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'IHP', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}], 'overallOfficials': [{'name': 'Jose Antonio, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nova Southeastern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Southeastern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-principal Investigator', 'investigatorFullName': 'Cassandra Evans', 'investigatorAffiliation': 'Nova Southeastern University'}}}}