Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-29 @ 1:14 PM
Study NCT ID:
NCT00795834
Status:
UNKNOWN
Last Update Posted:
2008-11-21
First Post:
2008-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Beverage Rich in Fruit Extracts on Risk Factors Associated With Cardiovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2009-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-11-19', 'studyFirstSubmitDate': '2008-11-19', 'studyFirstSubmitQcDate': '2008-11-19', 'lastUpdatePostDateStruct': {'date': '2008-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vascular Function (measured by Laser Doppler Iontophoresis and Pulse Wave Analysis / Pulse Wave Velocity)', 'timeFrame': 'Baseline and post intervention'}], 'secondaryOutcomes': [{'measure': 'Established and novel blood markers for vascular disease', 'timeFrame': 'baseline and post intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['polyphenolics', 'flavonols', 'lipids', 'endothelial function', 'vascular risk factors'], 'conditions': ['Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '26797134', 'type': 'DERIVED', 'citation': 'Mullan A, Delles C, Ferrell W, Mullen W, Edwards CA, McColl JH, Roberts SA, Lean ME, Sattar N. Effects of a beverage rich in (poly)phenols on established and novel risk markers for vascular disease in medically uncomplicated overweight or obese subjects: A four week randomized placebo-controlled trial. Atherosclerosis. 2016 Mar;246:169-76. doi: 10.1016/j.atherosclerosis.2016.01.004. Epub 2016 Jan 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effects of a novel beverage rich in polyphenols (compounds present in fruit extracts) on risk factors associated with cardiovascular disease.', 'detailedDescription': 'This study will assess the potential of a beverage containing plant and fruit extracts rich in polyphenolics to modulate vascular risk.\n\nNovel risk factors for vascular disease will be assessed including non-invasive assessment of vascular function by pulse wave analysis / pulse wave velocity and laser doppler iontophoresis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>/= 55 years\n* BMI \\> 25\n\nExclusion Criteria:\n\n* Present smoker or smoked within the last 2 years\n* HBA1C \\> 6.0%\n* eGFR\\<60\n* LFT \\>/= 3 times upper limit of normal\n* Hypertension: systolic blood pressure \\> 160mmHg; diastolic blood pressure \\> 90mmHg, or on medication for hypertension.\n* Chronic disease, likely to be clinically relevant (eg:\n\ncardiorespiratory, rheumatological, cerebrovascular or neoplastic disease)\n\n* Vitamin supplements within the previous 14 days\n* Medications which, in the opinion of the investigators, are known to influence vascular function (eg corticosteroids).'}, 'identificationModule': {'nctId': 'NCT00795834', 'briefTitle': 'Effects of a Beverage Rich in Fruit Extracts on Risk Factors Associated With Cardiovascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Glasgow'}, 'officialTitle': 'Pilot Study to Assess Effects of Novel Beverages on Established and Novel Risk Markers for Vascular Disease', 'orgStudyIdInfo': {'id': '07/S0704/110'}, 'secondaryIdInfos': [{'id': 'RN08BI013'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Beverage', 'interventionNames': ['Dietary Supplement: Placebo Beverage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High Polyphenol Beverage', 'interventionNames': ['Dietary Supplement: High polyphenol beverage']}], 'interventions': [{'name': 'High polyphenol beverage', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Antioxidant capacity umol TE/L(ORAC): 19987 Polyphenolic Content(mcg/ml): 1445 Vitamin C (mg/100ml): 35.35 Calorie Content (Kcal/250ml):40.0\n\n250ml twice daily for 1 month (56 doses)', 'armGroupLabels': ['High Polyphenol Beverage']}, {'name': 'Placebo Beverage', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Antioxidant capacity umol TE/L(ORAC): negligible Polyphenolic Content(mcg/ml): negligible Vitamin C (mg/100ml): 0.00 Calorie Content (Kcal/250ml):40.0\n\n250ml twice daily for 1 month (56 doses)', 'armGroupLabels': ['Beverage']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G12 8TA', 'city': 'Glasgow', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Adam Mullan, MBChB BSc MRCP', 'role': 'CONTACT', 'phone': '+44-141-330-2569'}, {'name': 'Adam WF Mullan, BSc MBChB MRCP', 'role': 'SUB_INVESTIGATOR'}, {'name': 'William Ferrell, MBChB PhD FRCP', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christine Edwards, BSc PhD R.Nutr FHEA', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alan Crozier, BSc PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gina Borges, MSc PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'British Heart Foundation Glasgow Cardiovascular Research Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'centralContacts': [{'name': 'Adam WF Mullan, MBChB MRCP', 'role': 'CONTACT', 'email': 'a.mullan@clinmed.gla.ac.uk', 'phone': '+44-141-330-2569'}], 'overallOfficials': [{'name': 'Naveed Sattar, MBChB PhD FRCPath FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Glasgow'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Glasgow', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Professor Naveed Sattar', 'oldOrganization': 'University of Glasgow'}}}}