Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-27 @ 11:47 AM
Study NCT ID:
NCT02987868
Status:
COMPLETED
Last Update Posted:
2018-02-08
First Post:
2016-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Frank.Greenway@pbrc.edu', 'phone': '225-763-2578', 'title': 'Dr. Frank Greenway, Chief of Outpatient Clinic', 'organization': 'Pennington Biomedical Research Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Amino Acid Supplement', 'description': 'Supplements with the proprietary amino acid derivative blend.\n\nAmino acid supplement: An orally administered supplement of the proprietary amino acid derivative', 'otherNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Non-active\n\nPlacebo: A non-active orally administered supplement of the proprietary amino acid derivative', 'otherNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change of Triiodthyronine Over Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amino Acid Supplement', 'description': 'Supplements with the proprietary amino acid derivative blend.\n\nAmino acid supplement: An orally administered supplement of the proprietary amino acid derivative'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Non-active\n\nPlacebo: A non-active orally administered supplement of the proprietary amino acid derivative'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.3', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '-6.1', 'spread': '8.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-120 minutes, at Baseline and post dose, week 1 and week 3', 'description': 'Measure Triiodthyronine at times 0-120 minutes on two occasions about one week apart. On one occasion, the proprietary amino acid derivative blend will be given orally at time 0 in capsule form, and on the other occasion the capsules will contain no amino acids.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Amino Acid Supplement First, Then Placebo', 'description': 'An orally administered amino acid supplement first, and after washout period, placebo.\n\nPlacebo: A non-active orally administered supplement of the proprietary amino acid derivative\n\nAmino acid supplement: Supplements with the proprietary amino acid derivative blend.'}, {'id': 'FG001', 'title': 'Placebo First, Then Amino Acid Supplement', 'description': 'Non-active Placebo first, and after washout period, an orally administered amino acid supplement.\n\nPlacebo: A non-active orally administered supplement of the proprietary amino acid derivative\n\nAmino acid supplement: Supplements with the proprietary amino acid derivative blend.'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Wash Out Period 1 Week', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were Volunteers at Pennington Biomedical Research Center, Baton Rouge, LA USA, between October 2011 and March 2011.', 'preAssignmentDetails': '16 participants recruited; 16 Screened, 0 excluded (12 Males and 4 Females)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Supplements with the proprietary amino acid derivative blend.\n\nAmino acid supplement: An orally administered supplement of the proprietary amino acid derivative'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23', 'spread': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', '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': '9', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', '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': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-06', 'studyFirstSubmitDate': '2016-12-06', 'resultsFirstSubmitDate': '2017-10-03', 'studyFirstSubmitQcDate': '2016-12-06', 'lastUpdatePostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-06', 'studyFirstPostDateStruct': {'date': '2016-12-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change of Triiodthyronine Over Baseline', 'timeFrame': '0-120 minutes, at Baseline and post dose, week 1 and week 3', 'description': 'Measure Triiodthyronine at times 0-120 minutes on two occasions about one week apart. On one occasion, the proprietary amino acid derivative blend will be given orally at time 0 in capsule form, and on the other occasion the capsules will contain no amino acids.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Somatostatin', 'Thyroid Hormone', 'Growth Hormone'], 'conditions': ['Growth Hormone Treatment', 'Aging']}, 'referencesModule': {'references': [{'pmid': '33030391', 'type': 'DERIVED', 'citation': 'Heaton AL, Kelly C, Rood J, Tam CS, Greenway FL. Mechanism for the Increase in Human Growth Hormone with Administration of a Novel Test Supplement and Results Indicating Improved Physical Fitness and Sleep Efficiency. J Med Food. 2021 Jun;24(6):653-659. doi: 10.1089/jmf.2020.0109. Epub 2020 Oct 8.'}]}, 'descriptionModule': {'briefSummary': 'In a recent randomized, double-blind, cross-over clinical trial, serum growth hormone (hGH) increased 682% above baseline 120 minutes after oral administration of an amino acid-based dietary supplement (SeroVital), p=0.01 vs placebo. In contrast to the mechanism of hGH stimulation by ghrelin, the investigators hypothesize that the supplement suppresses somatostatin, a know inhibitor of both hGH and TSH. To test this hypothesis, the investigators measured triiodothyronine (T3) after administration of the amino acid-base supplement.', 'detailedDescription': 'Two molecular targets that regulate the synthesis and secretion of human growth hormone (hGH) include 1) ghrelin, an endogenous ligand secreted by the stomach that also has appetite-stimulation properties distinct from its hGH-stimulating effects, and 2) somatostatin, a family of 14 and 28 amino acid peptides that act as a potent noncompetitive inhibitor of the release of hGH. the investigators recently reported that oral administration of a 2.9g/dose of SeroVital, a blend of l-lysine HCl, l-arginine HCL, oxo-proline, N-acetyl-l-cysteine, l-glutamine, and schizonepeta (aerial parts) powder, leads to a significant 682% mean increase in endogenous hGH levels in male and female subjects in a period of 120 minutes following acute consumption. In the work presented here, the investigators seek to characterize the mechanistic target associated with this measured increase in endogenous hGH by SeroVital, which the investigators hypothesize to be somatostatin. The investigators test this hypothesis by assaying thyroid function, a secondary inhibition target of somatostatin. The investigators further compare our findings to ghrelin-based hGH secretagogues.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 12 healthy males and 4 healthy females\n* Between 18 and 70 years\n\nExclusion Criteria:\n\n* Pregnant or nursing\n* Taking any chronic medication including birth control pills.'}, 'identificationModule': {'nctId': 'NCT02987868', 'briefTitle': 'Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'Effects of an Amino Acid-Based hGH Secretagogue on Triiodythyronine', 'orgStudyIdInfo': {'id': 'PBRC 10043 - HGH/Somatostatin'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Supplement 1st day, placebo 2nd day', 'description': 'Administration of oral supplement (proprietary amino acid derivative blend). Half of the participants took the Amino acid supplement first day and half of the participants took the Amino acid supplement second day.', 'interventionNames': ['Drug: Amino acid supplement first day', 'Drug: Placebo second day']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 1st day, supplement 2nd day', 'description': 'Half of the participants took the placebo first day and half of the participants took placebo second day.', 'interventionNames': ['Drug: Placebo first day', 'Drug: Amino acid supplement second day']}], 'interventions': [{'name': 'Amino acid supplement first day', 'type': 'DRUG', 'otherNames': ['SeroVital™'], 'description': 'An orally administered supplement of the proprietary amino acid derivative', 'armGroupLabels': ['Supplement 1st day, placebo 2nd day']}, {'name': 'Placebo first day', 'type': 'DRUG', 'otherNames': ['Non-active'], 'description': 'A non-active orally administered supplement of the proprietary amino acid derivative', 'armGroupLabels': ['Placebo 1st day, supplement 2nd day']}, {'name': 'Amino acid supplement second day', 'type': 'DRUG', 'otherNames': ['SeroVital™'], 'description': 'An orally administered supplement of the proprietary amino acid derivative', 'armGroupLabels': ['Placebo 1st day, supplement 2nd day']}, {'name': 'Placebo second day', 'type': 'DRUG', 'otherNames': ['Non-active'], 'description': 'A non-active orally administered supplement of the proprietary amino acid derivative', 'armGroupLabels': ['Supplement 1st day, placebo 2nd day']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Frank Greenway, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedical Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Frank Greenway', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}