Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT07194720
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2025-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of the Cornelian Cherry Supplementation on the Selected Physiological Parameters in Marathon Runners
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2025-09-18', 'studyFirstSubmitQcDate': '2025-09-18', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systemic vascular resistance', 'timeFrame': 'From the beginning to the end of a supplementation period at 4 weeks.', 'description': 'Resting systemic vascular resistance, evaluated non-invasively with a finger cuff-based device.'}, {'measure': 'Office blood pressure values (mean, systolic, diastolic)', 'timeFrame': 'From the beginning to the end of a supplementation period at 4 weeks.', 'description': 'Resting arterial blood pressure values (mean, systolic, diastolic), measured continuously with a non-invasive, finger cuff-based device.'}], 'secondaryOutcomes': [{'measure': 'Peripheral chemoreflex sensitivity', 'timeFrame': 'From the beginning to the end of a supplementation period at 4 weeks.', 'description': 'Peripheral chemoreflex sensitivity, measured with the transient hypoxia test.'}, {'measure': 'eNOS expression', 'timeFrame': 'From the beginning to the end of a supplementation period at 4 weeks.', 'description': 'Endothelial nitric oxide synthase expression, evaluated in the peripheral blood samples.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cornus mas L.', 'systemic vascular resistance', 'peripheral chemoreflex', 'endurance training', 'nitric oxide', 'endothelium', 'autonomic nervous system', 'blood pressure'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Growing body of evidence indicates favorable effects of Cornus mas (Cornelian cherry) supplements on cardiometabolic risk, including the improvement of HDL and glycemic indices, in line with vascular benefits. Experimental data feature bioactives from Cornelian cherry as potential modulators of vascular function and blood pressure, plausibly via endothelial nitric oxide-related pathways, with possible downstream effects on autonomic reflex control; nevertheless, such links in humans remain poorly explored to date, especially in terms of endurance training and hypoxia tolerance.\n\nIn this cross-over, placebo-controlled study, a group of healthy amateur long-distance runners underwent two stages of a four-week dietary intervention (separated by four weeks of washout period), receiving Cornelian cherry lyophilisate or placebo. Each supplementation stage was accompanied by the comprehensive evaluation of the cardio-respiratory parameters and endothelial function.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age above 45 years\n\nExclusion Criteria:\n\n* chronic disease of the nervous, cardiovascular or respiratory system\n* disease of the digestive system, including history of the intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance and other malabsorption disorders\n* blood pressure-lowering treatment within the past year\n* tobacco smoking within the past year\n* antibiotic/probiotic treatment and laxative/prokinetic usage in three months preceding the anticipated enrollment'}, 'identificationModule': {'nctId': 'NCT07194720', 'briefTitle': 'Effects of the Cornelian Cherry Supplementation on the Selected Physiological Parameters in Marathon Runners', 'organization': {'class': 'OTHER', 'fullName': 'Wroclaw Medical University'}, 'officialTitle': 'Effects of the Cornelian Cherry (Cornus Mas L.) Lyophilisate Supplementation on the Selected Physiological Parameters in Amateur Long-Distance Runners', 'orgStudyIdInfo': {'id': 'DEREN.23.25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cornus mas lyophilisate', 'interventionNames': ['Dietary Supplement: Cornus mas lyophilisate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Cornus mas lyophilisate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants receiving a Cornus mas (Cornelian cherry) lyophilisate for 4 weeks.', 'armGroupLabels': ['Cornus mas lyophilisate']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants receiving a starch- and sugar-based placebo for 4 weeks.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50-376', 'city': 'Wroclaw', 'state': 'Lower Silesian Voivodeship', 'country': 'Poland', 'facility': 'Wroclaw Medical University', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is a small trial which includes solely healthy volunteers. Therefore, data will not be shared at this instance.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wroclaw Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wrocław University of Environmental and Life Sciences', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rafał Seredyński', 'investigatorAffiliation': 'Wroclaw Medical University'}}}}