Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-02 @ 4:03 PM
Study NCT ID:
NCT02459756
Status:
COMPLETED
Last Update Posted:
2016-02-09
First Post:
2015-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anthocyanin-rich Blackcurrant and Vascular Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014867', 'term': 'Water'}, {'id': 'D013395', 'term': 'Sucrose'}, {'id': 'D005947', 'term': 'Glucose'}, {'id': 'D005632', 'term': 'Fructose'}, {'id': 'C008315', 'term': 'maltodextrin'}, {'id': 'C030298', 'term': 'malic acid'}, {'id': 'D019343', 'term': 'Citric Acid'}, {'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D007661', 'term': 'Ketoses'}, {'id': 'D002951', 'term': 'Citrates'}, {'id': 'D014233', 'term': 'Tricarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-08', 'studyFirstSubmitDate': '2015-05-20', 'studyFirstSubmitQcDate': '2015-06-01', 'lastUpdatePostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in vascular reactivity measured by flow-mediated dilatation (FMD)', 'timeFrame': 'Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention'}, {'measure': 'Change from baseline in platelet function measured by agonist-induced platelet aggregation', 'timeFrame': 'Acute study: measured at baseline and 2 and 4 h post intervention'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in the concentration of polyphenols and their metabolites and degradants in blood and urine samples measured by HPLC-MS/MS', 'timeFrame': 'Acute study: plasma measured at baseline and 1, 2, 4, 6 and 24 h post intervention, urine measured at baseline and 1, 2, 4, 6 and 6-24 h post intervention'}, {'measure': 'Change from baseline in vascular function measured by digital volume pulse (DVP)', 'timeFrame': 'Acute study: measured at baseline and 2, 4 and 6 h post intervention'}, {'measure': 'Change from baseline in blood pressure', 'timeFrame': 'Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention'}, {'measure': 'Change from baseline in the concentration of nitric oxide in plasma measured by ozone-based chemiluminescence', 'timeFrame': 'Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention'}, {'measure': 'Change from baseline in the concentration of selected cytokines (TNF-a, IL-1b, IL-6, IL-8 and IL-10) in plasma measured using a cytometric bead array kit from BD Biosciences', 'timeFrame': 'Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention'}, {'measure': 'Change from baseline in platelet function (numbers of circulating micro particles by nano particle tracking analysis)', 'timeFrame': 'Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention (urine metabonomics additionally 6-24h)'}, {'measure': 'Metabonomics on urine and plasma samples measured by nuclear magnetic resonance spectroscopy', 'timeFrame': 'Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention (urine metabonomics additionally 6-24h)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['anthocyanins', 'bioavailability'], 'conditions': ['Vascular Stiffness', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '40414296', 'type': 'DERIVED', 'citation': 'Amini AM, Zhou R, Austermann K, Kralova D, Serra G, Ibrahim IS, Corona G, Bergillos-Meca T, Aboufarrag H, Kroon PA, Spencer JP, Yaqoob P. Acute Effects of an Anthocyanin-Rich Blackcurrant Beverage on Markers of Cardiovascular Disease Risk in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial. J Nutr. 2025 Jul;155(7):2275-2289. doi: 10.1016/j.tjnut.2025.05.017. Epub 2025 May 23.'}]}, 'descriptionModule': {'briefSummary': 'Regular consumption of fruits and vegetables may improve human health and reduce the risk of chronic diseases, such as heart disease, certain cancers and type 2 diabetes, but the active components and the underlying mechanisms are poorly understood. Berry fruits are abundant in anthocyanins and this study aims to test the hypothesis that ingestion of an anthocyanin-rich blackcurrant beverage will improve markers of cardiovascular health (health of blood vessels, inflammation and platelet function). Further, the study will investigate the anthocyanin bioavailability from the blackcurrant beverage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 30-55 years\n* Non-smoker\n* BMI between 20 - 30 kg/m2\n* Generally healthy as established by a 'health and lifestyle' questionnaire and a screening blood sample\n* Blood pressure \\< 140/90mmHg\n* Total cholesterol \\< 6.2 mmol/L\n* Fasting glucose \\< 7.0 mmol/L\n\nExclusion Criteria:\n\n* Diabetes mellitus\n* Heart problems, stroke, vascular disease\n* Inflammatory disease\n* Kidney, liver, pancreas or gastrointestinal diseases\n* Medication for hyperlipidaemia, hypertension, hypercoagulation, inflammatory conditions\n* Asthma\n* Allergies\n* Smokers (social smokers who agree to abstain for 1 month before and during the study not excluded)\n* Taking phytochemical, antioxidant or fish oil supplements (unless willing to stop for the study period)\n* Taking aspirin \\> 2 times per month and unwilling to abstain from aspirin ingestion for 14 days prior each study visit\n* History of alcohol misuse\n* Consumption of alcohol \\>21 units (men) or \\>15 units (women)\n* Vegans\n* Intense aerobic exercise \\>20 min 3 x per week\n* Participation in another clinical trial\n* Antibiotics in previous 3 months before study\n* Low haemoglobin levels\n* Females who are pregnant, lactating, or if of reproductive age and not using a reliable form of contraception (including abstinence)"}, 'identificationModule': {'nctId': 'NCT02459756', 'briefTitle': 'Anthocyanin-rich Blackcurrant and Vascular Function', 'organization': {'class': 'OTHER', 'fullName': 'University of Reading'}, 'officialTitle': 'Effects of an Anthocyanin-rich Blackcurrant Beverage on Cardiovascular Function', 'orgStudyIdInfo': {'id': 'UREC 14/17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Spray dried blackcurrant powder dissolved in water', 'interventionNames': ['Other: Beverage: Spray dried blackcurrant powder dissolved in water']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '(sucrose, glucose, fructose, maltodextrin, malic acid, citric acid, vitamin C, artificial blackcurrant flavouring and low-nitrate water)', 'interventionNames': ['Other: Beverage: Placebo (sucrose, glucose, fructose, maltodextrin, malic acid, citric acid, vitamin C, artificial blackcurrant flavouring and low-nitrate water)']}], 'interventions': [{'name': 'Beverage: Spray dried blackcurrant powder dissolved in water', 'type': 'OTHER', 'armGroupLabels': ['Intervention']}, {'name': 'Beverage: Placebo (sucrose, glucose, fructose, maltodextrin, malic acid, citric acid, vitamin C, artificial blackcurrant flavouring and low-nitrate water)', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'RG6 6AP', 'city': 'Reading', 'country': 'United Kingdom', 'facility': 'University of Reading', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}], 'overallOfficials': [{'name': 'Parveen Yaqoob, DPhil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Reading'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Reading', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Parveen Yaqoob', 'investigatorFullName': 'Professor Parveen Yaqoob, MA, DPhil, RNutr, FAfN', 'investigatorAffiliation': 'University of Reading'}}}}