Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT05995002
Status:
COMPLETED
Last Update Posted:
2025-05-06
First Post:
2023-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anthocyanin Intake on Cardiometabolic Biomarkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D023921', 'term': 'Coronary Stenosis'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-03', 'studyFirstSubmitDate': '2023-08-08', 'studyFirstSubmitQcDate': '2023-08-08', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma inflammatory factors concentration', 'timeFrame': '8 weeks', 'description': 'fasting plasma concentration of C-reactive protein and IL-6'}], 'secondaryOutcomes': [{'measure': 'Plasma concentration of insulin', 'timeFrame': '8 weeks', 'description': 'Fasting plasma concentration of insulin'}, {'measure': 'Plasma levels of lipids and lipoproteins', 'timeFrame': '8 weeks', 'description': 'Fasting plasma levels of triglycerides, HDL-cholesterol, and LDL-cholesterol'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Stenosis']}, 'descriptionModule': {'briefSummary': 'Flavonoids are one of the main groups of polyphenols. Anthocyanins, which are a subgroup of the flavonoid family, are found in a number of fruits and some vegetables. In epidemiological studies, high dietary intake of polyphenols has been associated with improvement of some cardiometabolic risk factors in high-risk individuals. Furthermore, in controlled studies, consumption of polyphenol-rich food sources or anthocyanin extract supplementation has improved some cardiometabolic factors. In the present study, the effect of diet enriched with anthocyanin-rich food sources on cardiometabolic factors will be studied in coronary artery disease patients.', 'detailedDescription': "This study is an unblinded randomized controlled clinical trial. In this study, among the patients referred to Shahid Modares Hospital (Tehran, IRAN), those who are willing to participate and have inclusion criteria will be recruited. Inclusion criteria are coronary heart disease with recent coronary angiography, age range of 30-75 years. Exclusion criteria are end-stage renal disease, patients undergoing chemotherapy or radiotherapy, patients with inflammatory bowel syndrome, patients being treated with glucocorticoid drugs or antibiotics. Patients are randomly assigned to one of two study groups, including the control group and the group consuming food sources rich in anthocyanin in the diet. The duration of the study will be 8 weeks. In the control group, a general recommendation related to a healthy diet such as reducing the intake of saturated fats, sodium, and simple sugars, is provided. In the anthocyanin-rich diet group, the weekly food plan aims to increase the consumption of anthocyanin-rich sources such as berries, black grapes (or currants), cherries, strawberries, pomegranates, and red onions. The patients' drug regimen will not change during the study. Patients are asked not to use over-the-counter herbal medicines and nutritional supplements during the study. At the beginning and end of the study, blood,"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* coronary heart disease with recent coronary angiography\n\nExclusion Criteria:\n\n* End-stage renal disease,\n* Patients undergoing chemotherapy or radiotherapy,\n* Patients with inflammatory bowel syndrome\n* Patients being treated with glucocorticoid drugs or antibiotics.'}, 'identificationModule': {'nctId': 'NCT05995002', 'briefTitle': 'Anthocyanin Intake on Cardiometabolic Biomarkers', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University'}, 'officialTitle': 'Effects of Increasing Anthocyanin Intake on Cardiometabolic Biomarkers in Patients With Coronary Artery Disease', 'orgStudyIdInfo': {'id': '43004233'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Conventional drug treatment with a general recommendation for a healthy diet.'}, {'type': 'EXPERIMENTAL', 'label': 'Anthocyanin-rich diet group', 'description': 'Conventional drug treatment with a weekly food plan aims to increase the consumption of anthocyanin-rich sources', 'interventionNames': ['Other: Anthocyanin-rich diet']}], 'interventions': [{'name': 'Anthocyanin-rich diet', 'type': 'OTHER', 'description': 'A weekly food plan aims to increase the consumption of anthocyanin-rich sources such as berries, black grapes (or currants), cherries, strawberries, pomegranates, and red onions.', 'armGroupLabels': ['Anthocyanin-rich diet group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Shahid Modares Hospital', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Javad Nasrollahzadeh', 'investigatorAffiliation': 'Shahid Beheshti University of Medical Sciences'}}}}