Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-26 @ 8:01 AM
Study NCT ID:
NCT04471792
Status:
COMPLETED
Last Update Posted:
2025-12-08
First Post:
2020-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Creatine Use and Muscle Stretching in Peripheral Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003401', 'term': 'Creatine'}, {'id': 'D002482', 'term': 'Cellulose'}], 'ancestors': [{'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mullerdelp@vet.k-state.edu', 'phone': '3522269535', 'title': 'Dr. Judy Delp', 'organization': 'Kansas State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Creatine Monohydrate', 'description': 'Creatine Monohydrate will be given at a 5 day loading period (10g/day) followed by a maintenance phase (5 g/day). The objectives of the current trial are to investigate if creatine supplementation plus muscle stretching improves 6-minute walking distance and muscle oxygenation in patients with peripheral artery disease.\n\nCreatine monohydrate: Creatine monohydrate will be used in combination with muscle stretching.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cellulose', 'description': 'These participants will consume a fiber supplement in place of creatine monohydrate at a matched dose with muscle stretching.\n\nCellulose: Cellulose will be used in combination with muscle stretching.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Walking Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Creatine Monohydrate', 'description': 'Creatine Monohydrate will be given at a 5 day loading period (10g/day) followed by a maintenance phase (5 g/day). The objectives of the current trial are to investigate if creatine supplementation plus muscle stretching improves 6-minute walking distance and muscle oxygenation in patients with peripheral artery disease.\n\nCreatine monohydrate: Creatine monohydrate will be used in combination with muscle stretching.'}, {'id': 'OG001', 'title': 'Cellulose', 'description': 'These participants will consume a fiber supplement in place of creatine monohydrate at a matched dose with muscle stretching.\n\nCellulose: Cellulose will be used in combination with muscle stretching.'}], 'classes': [{'title': 'Baseline 6MWT Distance', 'categories': [{'measurements': [{'value': '375', 'spread': '84', 'groupId': 'OG000'}, {'value': '411', 'spread': '72', 'groupId': 'OG001'}]}]}, {'title': 'Post-stretching 6MWT Distance', 'categories': [{'measurements': [{'value': '405', 'spread': '65', 'groupId': 'OG000'}, {'value': '425', 'spread': '83', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.38', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P=0.380 comparing creatine vs. placebo', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Two-way ANOVA for pre vs. post values and for the difference between creatine vs. placebo'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and after 4 weeks of intervention', 'description': '6-minute walking test. This test measures the distance (in meters) that a patient can walk in 6 minutes.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Percent Oxygenation/Seconds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Creatine Monohydrate', 'description': 'Creatine Monohydrate will be given at a 5 day loading period (10g/day) followed by a maintenance phase (5 g/day). The objectives of the current trial are to investigate if creatine supplementation plus muscle stretching improves 6-minute walking distance and muscle oxygenation in patients with peripheral artery disease.\n\nCreatine monohydrate: Creatine monohydrate will be used in combination with muscle stretching.'}, {'id': 'OG001', 'title': 'Cellulose', 'description': 'These participants will consume a fiber supplement in place of creatine monohydrate at a matched dose with muscle stretching.\n\nCellulose: Cellulose will be used in combination with muscle stretching.'}], 'classes': [{'title': 'Baseline Δ StO2(%)/s', 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'Post-stretching Δ StO2(%)/s', 'categories': [{'measurements': [{'value': '0.64', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.883', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'p=0.883 when comparing effect of creatine to palcebo on rate/change in reperfusion slope', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Two-way ANOVA, pre vs. post differences and creatine vs. placebo differences were examined'}, {'pValue': '0.883', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and after 4 weeks of intervention', 'description': 'Near-infrared spectroscopy (NIRS) will be used to measure changes in oxygen saturation (%) in the gastrocnemius muscle. Measurement will be the rate (slope) of the change in oxygen saturation (StO2) per second. Thus rate of rate in oxygenation (slope) = StO2(%)/s = Δ StO2(%)/s', 'unitOfMeasure': 'delta StO2 (%/delta time(s)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Creatine Monohydrate', 'description': 'Creatine Monohydrate will be given at a 5 day loading period (10g/day) followed by a maintenance phase (5 g/day). The objectives of the current trial are to investigate if creatine supplementation plus muscle stretching improves 6-minute walking distance and muscle oxygenation in patients with peripheral artery disease.\n\nCreatine monohydrate: Creatine monohydrate will be used in combination with muscle stretching.'}, {'id': 'FG001', 'title': 'Cellulose', 'description': 'These participants will consume a fiber supplement in place of creatine monohydrate at a matched dose with muscle stretching.\n\nCellulose: Cellulose will be used in combination with muscle stretching.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '7 patients were assigned to stretch + creatine', 'groupId': 'FG000', 'numSubjects': '7'}, {'comment': '6 patient were assigned to stretch + placebo (cellulose).', 'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '7 patients completed stretch + creatine.', 'groupId': 'FG000', 'numSubjects': '7'}, {'comment': '6 patients completed stretch +placebo.', 'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '33 patients were screened. 3 patients were ineligible due to kidney disease and resting leg pain. Thirty patients met eligibility criteria. 8 patients did not respond to follow up and 9 patients lost interest. 13 patients consented to participate and were randomly assigned to either stretch+creatine or stretch+placebo. Zero healthy control participants were enrolled. Only participants with Peripheral Artery Disease were enrolled and randomized to either stretch+creatine or stretch+placebo."', 'preAssignmentDetails': 'All 13 patients that were consented completed baseline testing and randomization to either stretch +creatine or stretch + placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Creatine Monohydrate', 'description': 'Creatine Monohydrate will be given at a 5 day loading period (10g/day) followed by a maintenance phase (5 g/day). The objectives of the current trial are to investigate if creatine supplementation plus muscle stretching improves 6-minute walking distance and muscle oxygenation in patients with peripheral artery disease.\n\nCreatine monohydrate: Creatine monohydrate will be used in combination with muscle stretching.'}, {'id': 'BG001', 'title': 'Cellulose', 'description': 'These participants will consume a fiber supplement in place of creatine monohydrate at a matched dose with muscle stretching.\n\nCellulose: Cellulose will be used in combination with muscle stretching.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-09', 'size': 425764, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_003.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-09-12T18:15', 'hasProtocol': True}, {'date': '2022-04-02', 'size': 139004, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_004.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-09-04T15:27', 'hasProtocol': False}, {'date': '2022-04-02', 'size': 904220, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-02-11T10:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Randomized, single-blind research design.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2020-06-20', 'resultsFirstSubmitDate': '2025-08-11', 'studyFirstSubmitQcDate': '2020-07-13', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-21', 'studyFirstPostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Walking Distance', 'timeFrame': 'Baseline and after 4 weeks of intervention', 'description': '6-minute walking test. This test measures the distance (in meters) that a patient can walk in 6 minutes.'}], 'secondaryOutcomes': [{'measure': 'Change in Percent Oxygenation/Seconds', 'timeFrame': 'Baseline and after 4 weeks of intervention', 'description': 'Near-infrared spectroscopy (NIRS) will be used to measure changes in oxygen saturation (%) in the gastrocnemius muscle. Measurement will be the rate (slope) of the change in oxygen saturation (StO2) per second. Thus rate of rate in oxygenation (slope) = StO2(%)/s = Δ StO2(%)/s'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Muscle stretch', 'Creatine Monohydrate'], 'conditions': ['Peripheral Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '8828669', 'type': 'BACKGROUND', 'citation': 'Hultman E, Soderlund K, Timmons JA, Cederblad G, Greenhaff PL. Muscle creatine loading in men. J Appl Physiol (1985). 1996 Jul;81(1):232-7. doi: 10.1152/jappl.1996.81.1.232.'}, {'pmid': '29623692', 'type': 'BACKGROUND', 'citation': 'Hotta K, Behnke BJ, Arjmandi B, Ghosh P, Chen B, Brooks R, Maraj JJ, Elam ML, Maher P, Kurien D, Churchill A, Sepulveda JL, Kabolowsky MB, Christou DD, Muller-Delp JM. Daily muscle stretching enhances blood flow, endothelial function, capillarity, vascular volume and connectivity in aged skeletal muscle. J Physiol. 2018 May 15;596(10):1903-1917. doi: 10.1113/JP275459. Epub 2018 Apr 5.'}]}, 'descriptionModule': {'briefSummary': 'To utilize near-infrared spectroscopy to investigate if the research device, which induces muscle stretching, and creatine loading impact submaximal exercise performance in aged and PAD patients. Near-infrared spectroscopy (NIRS)-derived tissue oxygenation responses will be obtained during device placement (muscle stretch) and during a walking test (i.e., six-minute walk test). Muscle oxygenation at rest and during device placement will be assessed with Magnetic Resonance Imaging. It is hypothesized that the stretching protocol will improve both NIRS-derived tissue oxygenation and magnetic resonance-derived muscle oxygenation and that creatine supplementation will further improve phosphorus metabolite muscle performance. All patients will undergo either 4 weeks of stretch training with- or- without creatine supplementation according to previously defined creatine guidelines.', 'detailedDescription': 'Lower extremity peripheral artery disease (PAD) has been estimated to impact nearly 8.5 million U.S. adults above the age of 40, significantly increasing the rate of morbidity and mortality with concomitant decreases in quality of life. These patients are often given medical therapy (e.g., statins, antiplatelet, anticoagulants) and are also recommended to begin structured exercise programs. However, the limb ischemia that occurs during physical activity in these patients often limits exercise tolerance. A previous study by Bauer and colleagues showed that impaired muscle metabolism is a major contributor to functional limitations in PAD patients. These data are important in that they show alterations in blood flow and metabolic machinery likely impact exercise tolerance. As such, the development of tolerable countermeasures to improve limb blood flow and muscle energetics may increase adherence to exercise therapy and improve health outcomes in PAD patients. Previous work by the investigators has shown that daily muscle stretching, achieved via 30-minutes of ankle dorsiflexion, significantly improved soleus muscle function and muscle blood flow during exercise in a rat model of aging . In a follow-up study, the investigators have also shown that this model improves vascular function and walking function in PAD patients. As noted above, muscle energetics are delayed in PAD patients, so improving the rest-to-exercise transition with creatine supplementation may help PAD patients sustain exercise longer. The investigators are now testing to see if an added supplement can further improve the effects of muscle stretching in PAD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Ankle-brachial index (ABI) of 0.90 or less in either leg or clinical diagnosis by a medical doctor (PAD group only)\n2. Stable condition for at least 3 months (PAD group only)\n\nExclusion Criteria:\n\n1. Habitual exercise or cardiovascular rehabilitation program during the past 3 months\n2. Critical limb ischemia\n3. Blow or above-knee amputation\n4. Leg pain at rest\n5. Major surgery or lower extremity revascularization in the last 3 months\n6. Major medical illness treatment during the prior 12 months\n7. Central neurological disease\n8. Limited ankle or knee joint range of motion\n9. Requirement of oxygen with activity or exercise\n10. Heart failure\n11. Atrial fibrillation\n12. Wheelchair confinement or inability to walk\n13. Cognitive disorder\n14. Vasculitis problems including Takayasu's arteritis, Berger's disease, collagen disease or Reynaud's disease\n15. Overt cardiovascular disease\n16. Metabolic disease\n17. Renal disease"}, 'identificationModule': {'nctId': 'NCT04471792', 'briefTitle': 'Creatine Use and Muscle Stretching in Peripheral Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Florida State University'}, 'officialTitle': 'Creatine Monohydrate Use and Muscle Stretching in Peripheral Artery Disease', 'orgStudyIdInfo': {'id': '1150'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Creatine monohydrate', 'description': 'Creatine Monohydrate will be given at a 5 day loading period (10g/day) followed by a maintenance phase (5 g/day). The objectives of the current trial are to investigate if creatine supplementation plus muscle stretching improves 6-minute walking distance and muscle oxygenation in patients with peripheral artery disease.', 'interventionNames': ['Drug: Creatine monohydrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cellulose', 'description': 'These participants will consume a fiber supplement in place of creatine monohydrate at a matched dose with muscle stretching.', 'interventionNames': ['Dietary Supplement: Cellulose']}], 'interventions': [{'name': 'Creatine monohydrate', 'type': 'DRUG', 'description': 'Creatine monohydrate will be used in combination with muscle stretching.', 'armGroupLabels': ['Creatine monohydrate']}, {'name': 'Cellulose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Cellulose will be used in combination with muscle stretching.', 'armGroupLabels': ['Cellulose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32304', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida State University', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}], 'overallOfficials': [{'name': 'Judy Muller-Delp, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Judy Delp', 'investigatorAffiliation': 'Florida State University'}}}}