Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-02-20 @ 8:32 PM
Study NCT ID:
NCT05220059
Status:
UNKNOWN
Last Update Posted:
2022-03-11
First Post:
2021-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Polyphenol Extract on Cardiovascular Health Markers: a 4 Way Randomised Crossover Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059808', 'term': 'Polyphenols'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blinded'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Double-blind placebo controlled dose-response crossover study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-10', 'studyFirstSubmitDate': '2021-11-26', 'studyFirstSubmitQcDate': '2022-01-28', 'lastUpdatePostDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Lipid profile', 'timeFrame': 'Visit 1, 0 hour only', 'description': 'Measured in serum'}, {'measure': 'Glucose', 'timeFrame': 'Visit 1, 0 hour only', 'description': 'Measured in plasma'}, {'measure': 'Tolerance and acceptability of extract', 'timeFrame': 'Immediately after each intervention', 'description': 'Safety parameter. Measured on a 3-point likert scale (a lower value being a better outcome: 1, totally acceptable - 3, not at all acceptable)'}, {'measure': 'Height', 'timeFrame': 'Visit 1, 0 hour only', 'description': 'Measured in metres'}, {'measure': 'Weight', 'timeFrame': '0 hour, at each time-point', 'description': 'Measured in kg'}, {'measure': 'Angiotensin-converting enzyme (ACE)', 'timeFrame': 'Change over 2 hours', 'description': 'Exploratory outcome'}, {'measure': 'Circulating polyphenol metabolites', 'timeFrame': 'Change over 2 hours', 'description': 'Exploratory outcome. Measured in plasma'}, {'measure': 'Endothelin1', 'timeFrame': 'Change over 2 hours', 'description': 'Exploratory outcome. Measured in serum'}], 'primaryOutcomes': [{'measure': 'Flow Mediated Dilation', 'timeFrame': 'Change over 2 hours post dose', 'description': 'Acute change in endothelium-dependent flow-mediated dilation'}], 'secondaryOutcomes': [{'measure': 'Endothelium-independent vasodilation', 'timeFrame': 'Change after 2 hours post dose', 'description': 'Acute change in endothelium-independent vasodilation in response to Glyceryl trinitrate (GTN) drug'}, {'measure': 'Systolic blood pressure', 'timeFrame': 'Change over 2 hours post dose', 'description': 'Measured by brachial cuff'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'Change over 2 hours post dose', 'description': 'Measured by brachial cuff'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polyphenols', 'Cardiovascular Disease', 'Endothelial Function', 'Flow Mediated Dilation'], 'conditions': ['Cardiovascular Diseases', 'Endothelial Dysfunction', 'Blood Pressure']}, 'descriptionModule': {'briefSummary': 'Endothelial dysfunction is an early predictor of cardiovascular events in at-risk patients. It is characterized by impaired endothelium-dependent dilation and is primarily caused by reduced nitric oxide bioavailability secondary to oxidative stress and inflammation. Finding dietary/dietary supplement-oriented approaches to improving endothelial function is of public health interest.\n\nA randomized double-blind placebo controlled 4-way crossover study will be conducted to determine if acute consumption of a proprietary polyphenol extract (156 mg / 222 mg / 333 mg) will have a dose dependent response on endothelium-dependent flow-mediated dilation (ED-FMD) in fasting conditions, in comparison to a placebo (maltodextrin) in male smokers (20 - 45 years; n=20).FMD and blood pressure will be assessed at 0 \\& 2 hour timepoints following consumption of a single dose of polyphenol extract, accompanying blood samples will be collected to assess a range of endpoints including nitric oxide metabolites, angiotensin and polyphenols metabolites. Endothelium-independent vasodilation will also be measured 2 hours post consumption.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'Polyphenols have a gender effect, a single sex population was chosen to increase homogeneity of test population and therefore likelihood of observing an FMD response. Males were selected.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least two of the following risk markers; a BMI 25-30, waist circumference \\>94 cm, high normal blood pressure defined as either systolic 85-89 mmHg or diastolic 130-139 mmHg and have a normal ECG.\n\nExclusion Criteria:\n\n* An individual who has tested positive (self reported) 2 weeks before the study period.\n* A COVID-19 vaccinated individual who while receive the 1st or 2nd dose or booster 2 weeks before V0 or during the study period, due to the potential interaction of vaccine on markers assessed'}, 'identificationModule': {'nctId': 'NCT05220059', 'acronym': 'Activ Acute', 'briefTitle': 'Effect of Polyphenol Extract on Cardiovascular Health Markers: a 4 Way Randomised Crossover Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulster'}, 'officialTitle': 'Effect of Polyphenol Extract on Cardiovascular Health Markers: a 4 Way Randomised Crossover Study', 'orgStudyIdInfo': {'id': 'REC/21/0029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Polyphenol extract low dose', 'description': '156mg single dose', 'interventionNames': ['Dietary Supplement: Polyphenol extract']}, {'type': 'EXPERIMENTAL', 'label': 'Polyphenol extract medium dose', 'description': '222mg single dose', 'interventionNames': ['Dietary Supplement: Polyphenol extract']}, {'type': 'EXPERIMENTAL', 'label': 'Polyphenol extract high dose', 'description': '333mg single dose', 'interventionNames': ['Dietary Supplement: Polyphenol extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Maltodextrin single dose', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Polyphenol extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Single dose', 'armGroupLabels': ['Polyphenol extract high dose', 'Polyphenol extract low dose', 'Polyphenol extract medium dose']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Maltodextrin', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT52 1SA', 'city': 'Coleraine', 'state': 'Co.Londonderry', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ruth K Price', 'role': 'CONTACT', 'email': 'rk.price@ulster.ac.uk', 'phone': '+442870123878'}, {'name': 'Julie J Sittlington', 'role': 'CONTACT', 'email': 'jj.sittlington@ulster.ac.uk', 'phone': '+442870124101'}], 'facility': 'Human Intervention Studies Unit, Ulster University', 'geoPoint': {'lat': 55.13333, 'lon': -6.66667}}], 'centralContacts': [{'name': 'Christopher Gill', 'role': 'CONTACT', 'email': 'c.gill@ulster.ac.uk', 'phone': '+442870123181'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulster', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Parma', 'class': 'OTHER'}, {'name': "Activ'inside", 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}