Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 10:55 PM
Study NCT ID:
NCT06271434
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Krill Oil on Intestinal Integrity Markers in Elite Rowers.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013974', 'term': 'Thyroxine'}], 'ancestors': [{'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Triple'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All competitors will be randomly divided into two groups (double-blind):\n\nA. supplemented (n = 15), who will receive one capsule of a supplement called THYROX (Atlantic krill oil) four times a day.\n\nB. control (n = 15) receiving placebo. The supplementation period will be six weeks.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-06-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-15', 'studyFirstSubmitDate': '2024-02-14', 'studyFirstSubmitQcDate': '2024-02-14', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'I-FABP (intestinal fatty acid binding protein)', 'timeFrame': 'Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.', 'description': 'gut injury (enterocyte)'}, {'measure': 'CLDN-3', 'timeFrame': 'Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.', 'description': 'gut injury (tight junction)'}, {'measure': 'LBP (lipopolysaccharide binding protein)', 'timeFrame': 'Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.', 'description': 'endotoxin'}, {'measure': 'Catechyloamines, cortisol', 'timeFrame': 'Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.', 'description': 'stress hormones'}, {'measure': 'CD14', 'timeFrame': 'Blood samples will be taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 3-hour recovery period.', 'description': 'endotoxin'}], 'secondaryOutcomes': [{'measure': 'Food intake', 'timeFrame': 'day before the test, morning before the test', 'description': 'macro and micronutrients, fluids'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endotoxin', 'gastrointestinal symtoms', 'gut permeability'], 'conditions': ['Endothelial Dysfunction']}, 'descriptionModule': {'briefSummary': 'The study aims to check the influence of krill oil on markers of intestinal injury and intoxication.\n\nResearch group: the research will be conducted in a homogeneous group of professional rowers (N=30), all competitors qualified for the Polish Youth Rowing Team, aged 18 - 24. The sample size was confiremed in statistical analyses.\n\nRowing performance test will be conducted at the beginning and at the end of the training camp. Participants will perform a test on a rowing ergometer (Concept II, USA); each subject will have to cover a distance of 2000 m in the shortest possible time which is the distance starting in rowing competitions. The results of both tests will be considered in the selection for the championship team; therefore, athletes will be well motivated to perform both tests with maximum effort.\n\nHypotesis:\n\nThe krill oil will infleunce the gut barier integrity.', 'detailedDescription': "All competitors will be randomly divided into two groups (double-blind):\n\nA. supplemented (n = 15), who will receive one capsule of THYROX (Atlantic krill oil) four times a day.\n\nB. control (n = 15) receiving placebo. The supplementation period will be six weeks.\n\nCharacteristic of the supplement:\n\nTHYROX (Atlantic krill oil). The daily recommended intake of krill oil is 2000 mg, which includes 350 mg of omega-3 fatty acids, 240 mg of EPA, 110 mg of DHA, 800 mg of phospholipids, and 200 mg of astaxanthin.\n\nPlacebo will be produced by MLB Bitrade Sp. z o.o., Poznan.\n\nMeasurement: The project contractors will measure all parameters using the available equipment in the ZWKF laboratory in Gorzów Wielkopolski and commercial assay kits.\n\nPolyethylene clotting activator tubes (9 ml) will be centrifuged to separate the morphotic elements from the serum using a centrifuge (3000 rpm for 10 min). The serum will be pipetted into several Eppendorf tubes, then frozen (temp. -80 °C). All the following biochemical parameters will be determined from the extracted serum:\n\nusing the ELISA method by the test manufacturer's instructions. The designations include the flowing parameters:\n\na food diary will be filled day before the study and in the morning before the test, markers of gut injury: I-FABP (intestinal fatty acid binding protein), CLDN-3 (claudin 3) intoxication: LBP (lipopolysaccharide binding protein) stress hormones: ACTH and cortisol will be determined using the colourimetric method on the SPECTROstar Nano reader.\n\nThe lactate (La) concentration will be determined from the capillary blood immediately after collection using a commercially available kit (Diaglobal, Germany)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* training experience of a minimum of five years,\n* minimum training time per week 240 minutes,\n* all competitors qualified for the Polish Youth Rowing Team,\n* completing a food diary,\n* finishing 2000m ergometer test.\n\nExclusion Criteria:\n\n* Probiotics, prebiotics and antibiotic therapy within the last three months,\n* dietary regime,\n* gastrointestinal diseases,\n* lactose intolerance.'}, 'identificationModule': {'nctId': 'NCT06271434', 'briefTitle': 'Effects of Krill Oil on Intestinal Integrity Markers in Elite Rowers.', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Physical Education'}, 'officialTitle': 'Krill Oil Supplementation and Its Effect on Intestinal Permeability Markers in Elite Rowers.', 'orgStudyIdInfo': {'id': 'Olej z kryla/jelita'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supplemented', 'description': '(n = 15), who will receive one capsule of a supplement called THYROX (Atlantic krill oil) four times a day. The daily content of krill oil is 2000 mg, including omega-3 fatty acids 350 mg, EPA - 240 mg, DHA - 110 mg, phospholipids - 800 mg, astaxanthin 200 mg.\n\nThe supplementation period will be six weeks. Intervention: Drug: THYROX (Atlantic krill oil).', 'interventionNames': ['Dietary Supplement: THYROX (Atlantic krill oil']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'receiving placebo Intervention: Drug: Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'THYROX (Atlantic krill oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The daily content of krill oil is 2000 mg, including omega-3 fatty acids 350 mg, EPA - 240 mg, DHA- 110 mg, phospholipids - 800 mg, astaxanthin 200 mg.', 'armGroupLabels': ['Supplemented']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The control capsules will be made of olive oil of equal size and color.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hanna Dziewiecka, Msc', 'role': 'CONTACT', 'email': 'hannadziewiecka@gmail.com', 'phone': '606880282', 'phoneExt': '+48'}, {'name': 'Anna Skarpańska-Stejnborn, professor', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Anna Skarpańska-S, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Poznan University of Physical Education'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Physical Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}