Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2026-01-25 @ 7:10 AM
Study NCT ID:
NCT06452758
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relative Energy Deficiency in Rowers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-11', 'studyFirstSubmitDate': '2024-06-05', 'studyFirstSubmitQcDate': '2024-06-10', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '-FABP (intestinal fatty acid binding protein)to measure epithelial wall injury', 'timeFrame': 'Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 3-hour recovery period', 'description': 'I-FABP concentration measured in blood \\[ng/ml\\] using commercially availableenzyme-linked immunosorbent assays'}, {'measure': 'Leptin to measure long-term energy balance', 'timeFrame': 'Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 3-hour recovery period', 'description': 'Leptin concentration measured in blood \\[ng/ml\\] using commercially availableenzyme-linked immunosorbent assays'}, {'measure': 'Cortisol to measure stress', 'timeFrame': 'Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 3-hour recovery period', 'description': 'Stress hormone concentration measured in blood \\[ng/ml\\] using commercially available enzyme-linked immunosorbent assays'}, {'measure': 'sCD14 multifunctional lipopolysaccharide receptor', 'timeFrame': 'Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 3-hour recovery period', 'description': 'sCD14 concentration measured in blood \\[ug/ml\\] using commercially available enzyme-linked immunosorbent assays'}, {'measure': 'Claudin to measure tight junction leakage', 'timeFrame': 'Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 3-hour recovery period', 'description': 'Claudin concentration measured in blood \\[ng/ml\\] using commercially available enzyme-linked immunosorbent assays'}, {'measure': 'POMS', 'timeFrame': 'day before the test', 'description': 'Profile of Mood States'}, {'measure': 'REST-Q sport', 'timeFrame': 'day before the test', 'description': 'Recovery-Stress questionnaire for Athletes'}], 'secondaryOutcomes': [{'measure': 'energy', 'timeFrame': 'Time Frame: whole day (24hours) before test, in the morning before the test', 'description': 'energy \\[kcal \\]of food intake measured by food diary'}, {'measure': 'protein', 'timeFrame': 'Time Frame: whole day (24hours) before test, in the morning before the test', 'description': 'protein \\[g \\]of food intake measured by food diary'}, {'measure': 'fat', 'timeFrame': 'Time Frame: whole day (24hours) before test, in the morning before the test', 'description': 'fat \\[g \\]of food intake measured by food diary'}, {'measure': 'carbohydrate', 'timeFrame': 'Time Frame: whole day (24hours) before test, in the morning before the test', 'description': 'carbohydrate \\[g \\]of food intake measured by food diary'}, {'measure': 'fiber', 'timeFrame': 'Time Frame: whole day (24hours) before test, in the morning before the test', 'description': 'fiber \\[g \\]of food intake measured by food diary'}, {'measure': 'Body mass', 'timeFrame': 'in the morning before the test up to 1 hour after getting up', 'description': 'Body mass \\[kg\\] measured by electronic scale to the nearest 0,05 kg (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan)'}, {'measure': 'Body fat', 'timeFrame': 'in the morning before the test up to 1 hour after getting up', 'description': 'Body fat \\[%\\] measured by electronic scale (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan)'}, {'measure': 'Total body water', 'timeFrame': 'in the morning before the test up to 1 hour after getting up', 'description': 'Body water \\[%\\] measured by electronic scale (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan)'}, {'measure': 'Lean body mass', 'timeFrame': 'in the morning before the test up to 1 hour after getting up', 'description': 'Lean body mass \\[kg\\] measured by electronic scale (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan)'}, {'measure': 'Height', 'timeFrame': 'in the morning before the test up to 1 hour after getting up', 'description': '\\[cm\\] measured by high meter'}, {'measure': 'Self reported scale of gastrointestinal symptoms e.g.burping, heartburn, flatulence, abdominal pain, the urge to reiterate, vomiting, diarrhoea, nausea, dizziness, and stitch', 'timeFrame': 'up to 1 hours after the test', 'description': '10-point scale where 10 was the symptom with the greatest severity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['relative energy deficiency', 'gut permeability', 'rowers'], 'conditions': ['Endothelial Dysfunction', 'Mood Disorders', 'Malnutrition, Calorie']}, 'descriptionModule': {'briefSummary': 'This study aims to learn about relative energy deficiency in male and female rowers at the end of the direct sport preparation phase of the annual training cycle. The main questions:\n\n\\- How will energy intake influence leptin, cortisol levels, mood, gut discomfort, and permeability? The observational study involves male and female rowers from the Polish rowing team.\n\nParticipants will perform 2000 meter ergometer test and 6000 ergometer test in annual training cycle. Researchers will compare outcomes from both tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '23 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male rowers age 18 - 22 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Membership in Polish Rowing Team,\n* minimum five years of training,\n* total training time minimum of 240 minutes,\n* filling out a food diary,\n* finishing 2000-meter ergometer test.\n\nExclusion Criteria:\n\n* Probiotics within the last three months,\n* prebiotics within the last three months\n* antibiotic therapy within the last three months,\n* dietary regime,\n* gastrointestinal diseases.'}, 'identificationModule': {'nctId': 'NCT06452758', 'briefTitle': 'Relative Energy Deficiency in Rowers', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Physical Education'}, 'officialTitle': 'Relative Energy Deficiency in Females and Males Rowers - Observational Study', 'orgStudyIdInfo': {'id': 'REDs2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'male and female rowers', 'description': 'Rowers will perform 2000m ergometer test.A 2,000-m time trial is a standard test used to assess performance in rowers.', 'interventionNames': ['Other: 2000 meter ergometer test']}], 'interventions': [{'name': '2000 meter ergometer test', 'type': 'OTHER', 'description': 'Rowers will perform 2000m ergometer test. A 2,000-meter trial is a standard test used to assess performance in rowers.', 'armGroupLabels': ['male and female rowers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66-400', 'city': 'Gorzów Wielkopolski', 'state': 'Lubusz Voivodeship', 'country': 'Poland', 'contacts': [{'name': 'Hanna Dziewiecka, Msc', 'role': 'CONTACT', 'email': 'hannadziewiecka@gmail.com', 'phone': '606880282'}], 'facility': 'Poznan University of Physical Education, Faculty of Sport Sciences in Gorzow', 'geoPoint': {'lat': 52.73371, 'lon': 15.22505}}], 'centralContacts': [{'name': 'Hanna Dziewiecka, Msc', 'role': 'CONTACT', 'email': 'hannadziewiecka@gmail.com', 'phone': '606880282', 'phoneExt': '48'}, {'name': 'Anna Skarpańska-Stejnborn, Profesor', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Anna Skarpańska-Stejnborn, Profesor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Poznan University of Physical Education'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Physical Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}