Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2026-02-24 @ 8:50 AM
Study NCT ID:
NCT03041961
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2017-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aronia Berry Consumption on Vascular Function
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-02', 'studyFirstSubmitDate': '2017-02-02', 'studyFirstSubmitQcDate': '2017-02-02', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Plasma aronia berry (poly)phenol metabolites', 'timeFrame': 'Baseline 0 and 2 hours and 12 weeks 0 and 2 hours', 'description': 'Measured by liquid chromotography- mass spectrometry (LC/MS) 0 and 2 hours postconsumption'}, {'measure': 'Microbiome analysis', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Stool sample collection (Umnigene gut collection kit)'}], 'primaryOutcomes': [{'measure': 'Flow-mediated dilation', 'timeFrame': 'Baseline 0 and 2 hours and 12 weeks 0 and 2 hours', 'description': 'Change form Baseline Endothelial function at 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Pulse wave velocity', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Measured by SphygmoCor 0 and 2 hours postconsumption'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Automatical measurements 0 and 2 hours postconsumption'}, {'measure': 'Blood measurements- Blood lipids', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Cholesterol, HDL, LDL, triglycerides'}, {'measure': 'Blood measurements', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Haematology (White blood cell count, red blood cell count, Haemoglobin, hematocrit, platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils, reticulocytes, eosinophils'}, {'measure': 'Blood measurements-Electrolytes', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Urea, Creatinine, uric acid'}, {'measure': 'Blood measurements', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Liver values (bilirubin, lactate dehydrogenase, aspartate aminotransferase, gamma-glutamyltranspeptidase, total protein, albumine, alkaline phosphatase)'}, {'measure': 'Blood measurements -Glucose', 'timeFrame': 'Baseline and 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vascular function', 'Endothelial function', '(Poly)phenols'], 'conditions': ['Healthy Young Men']}, 'referencesModule': {'references': [{'pmid': '31152545', 'type': 'DERIVED', 'citation': 'Istas G, Wood E, Le Sayec M, Rawlings C, Yoon J, Dandavate V, Cera D, Rampelli S, Costabile A, Fromentin E, Rodriguez-Mateos A. Effects of aronia berry (poly)phenols on vascular function and gut microbiota: a double-blind randomized controlled trial in adult men. Am J Clin Nutr. 2019 Aug 1;110(2):316-329. doi: 10.1093/ajcn/nqz075.'}]}, 'descriptionModule': {'briefSummary': 'There is an increasing interest in the effects of various food derived polyphenols on vascular function. Arguably the most well-established vascular benefits are attributed to flavanols from cocoa beans and this has been supported by a successful health claim through the European Food Safely Authority in 2012. Berry fruits are another rich source of polyphenols that have vasoactive properties, and there is a growing body of research exploring these effects in various berries (blueberries, cranberries, strawberries) and other fruit products with similar polyphenol composition. A key (poly)phenol in berries and other fruits believed to provide much of the benefit is anthocyanins. When given as an isolated extract, 320 mg anthocyanins have been found to improve blood vessel function both acutely and in response to chronic consumption over 12 weeks.\n\nAronia berries are a native North American berry with high naturally occurring anthocyanins among other polyphenols. Based on their polyphenol composition, there is growing interest in the potential for Aronia berries to elicit health promoting cardio-metabolic effects. Specifically, Aronia berry extracts, which provide a concentrated source of polyphenols, may improve blood vessel function.\n\nThus, the primary focus of this project is to evaluate the effects of Aronia berry extracts of differing polyphenol dose on vascular endothelial function.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy men aged 18-45 years old\n* Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study\n* Are able to understand the nature of the study\n* Able to give signed written informed consent\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Manifest cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease\n* Hypertensive, as defined as SBP superior or equal to 140 mmHg or DBP superior or equal to 90 mmHg\n* Obese participants, defined as BMI superior or equal to 30\n* Diabetes mellitus and metabolic syndrome\n* Acute inflammation\n* Terminal renal failure\n* Malignancies\n* Abnormal heart rhythm (lower or higher than 60-100 bpm)\n* Allergies to berries or other significant food allergy.\n* Subjects under medication or on vitamin/dietary supplements.\n* Subjects who have lost more than 10% of their weight in the past 6 months or are currently in a diet\n* Subjects who reported participant in another study within one month before the study start\n* Subjects who smoke an irregular amount of cigarettes per day\n* Unable to swallow the capsule\n* Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements."}, 'identificationModule': {'nctId': 'NCT03041961', 'briefTitle': 'Aronia Berry Consumption on Vascular Function', 'organization': {'class': 'OTHER', 'fullName': "King's College London"}, 'officialTitle': 'Effects of Aronia Berry (Chokeberry) Extract on Vascular Function in Healthy Men: a 3 Month Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'Aronia FMD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Formulation containing inert artificially colored maltodextrin, once daily, in a 1-hard capsule regimen (500 mg)', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aronia full spectrum', 'description': 'Formulation of an aronia full spectrum ingredient in a 1-hard capsule regimen (500 mg)', 'interventionNames': ['Dietary Supplement: Aronia full spectrum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aronia extract', 'description': 'Formulation of an aronia extract ingredient in a 1-hard capsule regimen (500 mg)', 'interventionNames': ['Dietary Supplement: Aronia extract']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.', 'armGroupLabels': ['Placebo']}, {'name': 'Aronia full spectrum', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)', 'armGroupLabels': ['Aronia full spectrum']}, {'name': 'Aronia extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Powdered extract obtained from aronia berries (Aronia melanocarpa)', 'armGroupLabels': ['Aronia extract']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 9NH', 'city': 'London', 'state': 'Central London', 'country': 'United Kingdom', 'facility': 'Department of Life Sciences and Medecine', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College London", 'class': 'OTHER'}, 'collaborators': [{'name': 'Naturex-Dbs', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Dr Ana Rodriguez-Mateos', 'investigatorAffiliation': "King's College London"}}}}