Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT06133751
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2023-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of 8-week Supplementation With Black Chokeberry on Recovery in Highly Trained Rowers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018979', 'term': 'Myositis, Inclusion Body'}], 'ancestors': [{'id': 'D009220', 'term': 'Myositis'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Youth National Rowing Team of Poland'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants randomly divided into one of two groups. The supplemented group (n=7) receives chokeberry capsules, while the control group (n=8) receives a placebo product.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-23', 'studyFirstSubmitDate': '2023-10-27', 'studyFirstSubmitQcDate': '2023-11-13', 'lastUpdatePostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of total antioxidants (TAC)', 'timeFrame': '8 weeks', 'description': 'ELISA kits (SunRed Biotechnology Company) - Indicators of pro-oxidant-antioxidant balance'}, {'measure': 'interleukins: IL-2, IL-6, IL-10', 'timeFrame': '8 weeks', 'description': 'ELISA kits (SunRed Biotechnology Company) - Immunological indicators'}, {'measure': 'lactic acid', 'timeFrame': '8 weeks', 'description': 'Diaglobal, Berlin, Germany)'}, {'measure': 'LBP (lipopolysacharide-binding pro)', 'timeFrame': '8 weeks', 'description': 'ELISA kits (SunRed Biotechnology Company) - Gut parameter'}, {'measure': 'level of lipid peroxidation products (TBARS)', 'timeFrame': '8 weeks', 'description': 'ELISA kits (SunRed Biotechnology Company) - Indicators of pro-oxidant-antioxidant balance'}, {'measure': '(NO) nitric oxide', 'timeFrame': '8 weeks', 'description': 'obtained by indirect method Griessa - Indicators of pro-oxidant-antioxidant balance'}, {'measure': 'comet assay (DNA damage)', 'timeFrame': '8 weeks', 'description': 'comet assay BioTechne'}, {'measure': 'tumor necrosis factor (TNF α)', 'timeFrame': '8 weeks', 'description': 'ELISA kits (SunRed Biotechnology Company) - Immunological indicators'}, {'measure': 'myoglobin', 'timeFrame': '8 weeks', 'description': 'ELISA kits (SunRed Biotechnology Company)'}, {'measure': 'I-FABP (intestinal fatty acid binding protein)', 'timeFrame': '8 weeks', 'description': 'ELISA kits (SunRed Biotechnology Company) - Gut parameter'}, {'measure': 'Claudin3', 'timeFrame': '8 weeks', 'description': 'ELISA kits (SunRed Biotechnology Company) - Gut parameter'}], 'secondaryOutcomes': [{'measure': 'gastrointestinal symptom scale', 'timeFrame': '8 weeks', 'description': 'Self-reported 10-point scale, 10 is the most severe symptoms on the scale'}, {'measure': 'energy [kcal]', 'timeFrame': '8 weeks', 'description': 'dietitian program'}, {'measure': 'protein [g]', 'timeFrame': '8 weeks', 'description': 'dietitian program'}, {'measure': 'fat [g]', 'timeFrame': '8 weeks', 'description': 'dietitian program'}, {'measure': 'carbohydrate [g]', 'timeFrame': '8 weeks', 'description': 'dietitian program'}, {'measure': 'fiber [g]', 'timeFrame': '8 weeks', 'description': 'dietitian program'}, {'measure': 'body hight [m]', 'timeFrame': '8 weeks', 'description': 'secco 217 highmeter'}, {'measure': 'body mass [kg]', 'timeFrame': '8 weeks', 'description': 'body analyzer'}, {'measure': 'body fat [%,kg]', 'timeFrame': '8 weeks', 'description': 'body analyzer'}, {'measure': 'total body water [%,kg]', 'timeFrame': '8 weeks', 'description': 'body analyzer'}, {'measure': 'lean body mass [kg]', 'timeFrame': '8 weeks', 'description': 'body analyzer'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammation;Muscle(S)', 'Oxidative Stress Injury', 'Permeability; Increased']}, 'referencesModule': {'references': [{'pmid': '40873756', 'type': 'DERIVED', 'citation': 'Kaczmarczyk S, Kasperska A, Dziewiecka H, Ostapiuk-Karolczuk J, Cichon-Wozniak J, Basta P, Skarpanska-Stejnborn A. A single 2000-meter exercise test to assess exercise adaptation in elite rowers during the preparatory phase. Front Physiol. 2025 Aug 12;16:1544637. doi: 10.3389/fphys.2025.1544637. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'Purpose: To analyze the effects of 8-week supplementation with anthocyanin compounds contained in black chokeberry (Aronia melanocarpa) on indicators of inflammation and oxidative stress.\n\nHypothesis: Supplementation with anti-inflammatory and antioxidant anthocyanin compounds improves recovery from intense exercise by reducing inflammation and oxidative stress in highly trained rowers\n\nThe study consisted of a nutritional intervention (supplementation) - with compounds of natural origin - chokeberry extract (capsules) - 18% standardized for anthocyanin content (dose 3 x 200 mg per day) - that is, 107 mg of pure anthocyanins per day, or a placebo product that was made from chokeberry fiber\n\nStudy plan I term of the study\n\n1. Conduct a body composition analysis, body height, food diary, self reported gastrointestinal scale\n2. Collection of blood samples before the exercise test for biochemical determinations.\n3. Exercise test of 2000m on a rowing ergometer.\n4. Collection of blood immediately after exercise and 1 hours after\n5. Collection of blood for biochemical determinations 24 hours after the end of the exercise test\n6. Supplementation for 8 weeks 2nd test date Repeat the measurements from the 1st test date.\n\nParticipants: Youth National Rowing Team of Poland Experimental procedure: Observation of the effect of black chokeberry consumption on parameters of inflammation, oxidative stress and intestinal parameters during the immediate start preparation period in highly skilled rowers.', 'detailedDescription': "Participants Twenty participants from the Youth National Rowing Team of Poland have been recruited for the study. In the end, fifteen rowers participated in the study (two did not show up for the first date, three more were absent for the second date). Before the first and second dates of the study, a body composition analysis was performed using the TANITA MC-780 with an accuracy of 0.05 kg, and hight was measured throughout sea 217 hightmeter. The experiment was conducted in accordance with the Declaration of Helsinki. The study protocol was approved by the Ethical Committee of the Medical University of Poznan (resolution no. 390/22). All players were informed of the exact course of the study and gave written consent to participate.\n\nYouth National Rowing Team of Poland The athletes' diets were completely analyzed before each exercise test by a nutritionist. Participants, with the help of a dietician who was available during meals on test days, filled out food diaries. The amount of energy, protein, carbohydrates, fats and fiber were then analyzed using a commercially available program.\n\nExperimental procedure The rowers were randomly divided into two groups-supplemented and control, it was a double-blind study. Athletes in the supplemented group (n=7) consumed capsules with highly concentrated 18% chokeberry extract. One capsule contained 200 mg. In addition to chokeberry extract, each capsule also contained chokeberry fiber, E460b magnesium salts of stearic acid (anti-caking agent), E551 silicon dioxide (anti-caking agent), hydroxypropyl methylcellulose (capsule shell) and E171 titanium dioxide (shell color). The control group (n=8) consumed capsules that were made from chokeberry fiber. All additional substances the same as in capsules with chokeberry extract. The supplement and placebo product was manufactured by MBL BIOTRADE, Poznań. The rowers (both supplemented and control group) took 3 capsules a day (at breakfast, lunch and dinner) for 8 weeks. The athletes sipped each capsule with a glass of water.\n\nExercise test On two testing dates (before and after supplementation), the athletes performed a 2,000-meter test on a rowing ergometer (Concept II, USA). Athletes had to complete the test in the shortest possible time overcoming the maximum load. The results of the test were taken into account in the selection for the championship team so the athletes performed the task with great motivation. Before the test, each competitor individually performed a 5-minute warm-up.\n\nMaterial collection and examination Samples were taken at three time points: pre (before the exercise test) post (immediately after the exercise test and 1 hour after) and recovery (24 hours after the exercise test) both before and after the supplementation period. Blood samples were collected from the elbow vein into 9-ml tubes (to obtain serum) and centrifuged at 3,000 rpm and into 2.7-ml tubes (to determine morphology). Morphology was determined on the same day the samples were collected, while serum was frozen and stored at -80oC until assays were performed. In addition, before and immediately after the exercise test, capillary blood was drawn from the earlobe to determine lactate levels.\n\nMeasurements TAC (Total Antioxidant Capacity), TBARS (levels of lipid peroxidation products), IL-2, IL-6, IL-10, TNF-α and myoglobin levels were determined using ELISA kits (SunRed Biotechnology Company). Lactate levels were determined immediately after capillary blood sampling using a commercially available kit (Dr. Lange, Germany). The concentration of lactate was determined in mmol/l. intestinal parameters: LBP (lipopolysacharide-binding pro), Claudin3, I-FABP (intestinal fatty acid binding pro). After both tests, participants filled out self-reported gastrointestinal scale.\n\nAny data obtained during the research will be used only for the purposes of this research project. The participant has the right to access and correct his/her data, to obtain information regarding the processing of his/her personal data, to request the deletion or restriction of the processing of his/her data, the right to portability of the data provided, the right to object to the processing, and the right to withdraw consent to the processing of personal data at any time. Withdrawal of consent does not affect the lawfulness of processing carried out on the basis of consent before its withdrawal.\n\nThe confidential nature of the research documentation will be respected throughout the study. Legal requirements for the protection of personal data will be observed. In the study documentation, participants will be identified by a nadem code at the beginning of the study. The results of this study will be published after pooled data analysis. Thus, the identity of the participants will remain confidential.\n\nThe place of data storage is the university's branch office in Gorzow Wielkopolski.\n\nAll parameters will be analyzed using Elisamtests and read on the ELISAMAR reader. In terms of statistical measures, the following will be performed: descriptive statistics, Shapiro-Wilk test to assess normality, and multivariate analysis of variance ANOVA test."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Training experience a minimum of five years\n* Minimum training time per week 240 minute\n* Membership in the Youth National Rowing Team of Poland\n* Completion of the 2000m ergometer test on two test dates\n\nExclusion Criteria:\n\n* Taking other supplements containing anthocyanin compounds during the study period or a month earlier\n* Antibiotic therapy\n* Health problems'}, 'identificationModule': {'nctId': 'NCT06133751', 'briefTitle': 'Effect of 8-week Supplementation With Black Chokeberry on Recovery in Highly Trained Rowers', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Physical Education'}, 'officialTitle': 'Effect of 8-week Supplementation With Anthocyanin Compounds Contained in Black Chokeberry on Inflammation and Oxidative Stress Induced by Very Intense Exercise in Highly Trained Rowers', 'orgStudyIdInfo': {'id': 'SKaczmarczyk_PhD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supplemented group', 'description': 'Athletes in the supplemented group (n=7) consumed capsules with highly concentrated 18% chokeberry extract. One capsule contained 200 mg. In addition to chokeberry extract, each capsule also contained chokeberry fiber, E460b magnesium salts of stearic acid (anti-caking agent), E551 silicon dioxide (anti-caking agent), hydroxypropyl methylcellulose (capsule shell) and E171 titanium dioxide (shell color).\n\nThe rowers (both supplemented and control group) took 3 capsules a day (at breakfast, lunch and dinner) for 8 weeks. The athletes sipped each capsule with a glass of water.', 'interventionNames': ['Drug: black chokeberry (Aronia melanocarpa)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'The control group (n=8) consumed capsules that were made from chokeberry fiber.\n\nThe rowers (both supplemented and control group) took 3 capsules a day (at breakfast, lunch and dinner) for 8 weeks. The athletes sipped each capsule with a glass of water.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'black chokeberry (Aronia melanocarpa)', 'type': 'DRUG', 'description': 'Black chokeberry capsules standardized for anthocyanin compounds', 'armGroupLabels': ['Supplemented group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Chokeberry fiber placebo capsules', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Poznan', 'country': 'Poland', 'facility': 'University of Physical Education in Poznan', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'overallOfficials': [{'name': 'Anna Skarpańska-Stejnborn, 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'}}}}