Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-03-01 @ 3:40 AM
Study NCT ID:
NCT03540602
Status:
UNKNOWN
Last Update Posted:
2018-05-30
First Post:
2018-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polyphenol Rich Supplementation on Markers of Recovery From Intense Resistance Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063806', 'term': 'Myalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'To ensure that all subjects and researchers are unaware of the treatment assignments we will have one outside individual that will possess the knowledge of which subjects are given which supplement and which were given a placebo. This information will remain confidential until the study has been concluded. At the conclusion of the study, participants will be informed of which condition they were assigned. in an event of an emergency or the participant decides not to participate his condition will be revealed.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '20 male participants will start with a familiarization visit where they will receive either the placebo supplement or the polyphenol rich supplement that they will take for 7 days. After taking the supplement, the participants will come back and run through the acute resistance exercise protocol as well as return the next day for a post test. Next, the participants will undergo a "wash out" phase where they will not take any supplementation. At the end of these 2 weeks, the participants will then take the other supplement (i.e. if they took the polyphenol rich supplement in the first phase they will take the placebo supplement in the second phase). After a week of taking their assigned supplement, participants will complete the acute resistance exercise protocol and the post test.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-16', 'studyFirstSubmitDate': '2018-02-26', 'studyFirstSubmitQcDate': '2018-05-16', 'lastUpdatePostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Oxidative Stress', 'timeFrame': '7 weeks', 'description': 'Blood analyses will be used, 8 mL of blood will be taken from the participant six times per condition. The blood will be centrifuged to separate the serum/ plasma and analyzed by enzyme- linked immunosorbent assay (ELISA) for c- reactive protein and creatine kinase, and oxidative damage'}], 'secondaryOutcomes': [{'measure': 'Muscle soreness', 'timeFrame': '7 weeks', 'description': 'Subjects will mark a line on a 10cm scale that corresponds to the amount of muscular soreness they currently perceive'}, {'measure': 'Vertical Jump Performance', 'timeFrame': '7 weeks', 'description': 'Subjects will be instructed to stand on a NeuroCom Balance Manager forceplate with hands on hips. Subjects will then be instructed to perform 3 consecutive vertical jumps, as high as possible with minimal time between jumps. The jumps will later be assessed for power production.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polyphenol rich supplementation', 'Tart cherry', 'Lifting', 'Recovery'], 'conditions': ['Muscle Soreness']}, 'referencesModule': {'references': [{'pmid': '11160074', 'type': 'BACKGROUND', 'citation': "Reid MB. Invited Review: redox modulation of skeletal muscle contraction: what we know and what we don't. J Appl Physiol (1985). 2001 Feb;90(2):724-31. doi: 10.1152/jappl.2001.90.2.724."}, {'pmid': '3202155', 'type': 'RESULT', 'citation': 'Alessio HM, Goldfarb AH, Cutler RG. MDA content increases in fast- and slow-twitch skeletal muscle with intensity of exercise in a rat. Am J Physiol. 1988 Dec;255(6 Pt 1):C874-7. doi: 10.1152/ajpcell.1988.255.6.C874.'}, {'pmid': '11427763', 'type': 'RESULT', 'citation': 'Blair SN, Cheng Y, Holder JS. Is physical activity or physical fitness more important in defining health benefits? Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S379-99; discussion S419-20. doi: 10.1097/00005768-200106001-00007.'}, {'pmid': '18923182', 'type': 'RESULT', 'citation': 'Powers SK, Jackson MJ. Exercise-induced oxidative stress: cellular mechanisms and impact on muscle force production. Physiol Rev. 2008 Oct;88(4):1243-76. doi: 10.1152/physrev.00031.2007.'}]}, 'descriptionModule': {'briefSummary': "Strength training is commonly used as an intervention to increase muscle mass, thus improving a person's ability to undertake activities of daily living, or enhance athletic performance. The strength training regimen itself, while ultimately having beneficial effects, causes muscle fibers to be damaged, which the body has to recover from. As the body recovers, it rebuilds the muscle tissue and after multiple consecutive bouts of strength training, the muscle eventually becomes larger and stronger. Thus, it is the recovery from strength training exercise that ultimately determines how well the body adapts. Where inadequate recovery could eventually lead to overtraining and/or injury, optimizing the recovery process from strength training could maximize strength training adaptations. This concept of optimizing recovery has led to development of many supplements, including antioxidants, which may reduce the damage associated with strength training activities and therefore enhance positive adaptations. The purpose of this study is to assess the ability of a polyphenol rich supplementation to aid the recovery process from a demanding bout of resistance exercise"}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'genderBased': True, 'genderDescription': 'Must be male', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 6 months of resistance training experience with barbel back squat exercise\n\nExclusion Criteria:\n\n* Not currently taking any antioxidant supplements, not currently using any hormone replacement therapy or anabolic androgenic steroids.'}, 'identificationModule': {'nctId': 'NCT03540602', 'acronym': 'PRSRE', 'briefTitle': 'Polyphenol Rich Supplementation on Markers of Recovery From Intense Resistance Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Jacksonville University'}, 'officialTitle': 'Polyphenol Rich Supplementation on Markers of Recovery From Intense Resistance Exercise', 'orgStudyIdInfo': {'id': 'Polyphenol Supplementation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Rice flour capsule', 'interventionNames': ['Other: Placebo Oral Capsule [CEBOCAP]']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Polyphenol Rich Supplement', 'description': 'NordicCherry Tart Cherry Extract Powder 500 mg in capsule form', 'interventionNames': ['Dietary Supplement: Tart Cherry']}], 'interventions': [{'name': 'Tart Cherry', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['NordicCherry Tart Cherry Extract Powder 500 mg'], 'description': 'NordicCherry Tart Cherry Extract Powder 500 mg from Specnova, inc', 'armGroupLabels': ['Polyphenol Rich Supplement']}, {'name': 'Placebo Oral Capsule [CEBOCAP]', 'type': 'OTHER', 'description': 'Rice flour', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32211', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Heather Hausenblaus, PhD', 'role': 'CONTACT', 'email': 'hhausen@ju.edu', 'phone': '410-256-7975'}, {'name': 'David Hooper, PhD', 'role': 'CONTACT', 'email': 'dhooper4@ju.edu', 'phone': '904-256-7985'}], 'facility': 'Jacksonville University', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'centralContacts': [{'name': 'Heather Hausenblaus', 'role': 'CONTACT', 'email': 'hhausen@ju.edu', 'phone': '904-256-7975'}, {'name': 'David Hooper', 'role': 'CONTACT', 'email': 'dhooper4@ju.edu', 'phone': '904-256-7985'}], 'overallOfficials': [{'name': 'Heather Hausenblaus', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jacksonville University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jacksonville University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Specnova, inc', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}