Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-02-13 @ 10:37 AM
Study NCT ID:
NCT06483932
Status:
COMPLETED
Last Update Posted:
2025-05-06
First Post:
2024-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Barberry and Cardiometabolic Risk Factors in Individuals With Hypertriglyceridemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D015228', 'term': 'Hypertriglyceridemia'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D031204', 'term': 'Caloric Restriction'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002149', 'term': 'Energy Intake'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-03', 'studyFirstSubmitDate': '2024-06-26', 'studyFirstSubmitQcDate': '2024-06-26', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentration of triglycerides', 'timeFrame': 'At baseline, the fourth week and the eighth week of study', 'description': 'The plasma triglyceride concentration 12 hours after the subjects had fasted'}, {'measure': 'Plasma concentration of high-density lipoprotein cholesterol (HDL-C)', 'timeFrame': 'At baseline, the fourth week and the eighth week of study', 'description': 'The plasma HDL-C concentration 12 hours after the subjects had fasted'}], 'secondaryOutcomes': [{'measure': 'Body weight', 'timeFrame': 'At baseline, the fourth week and the eighth week of study', 'description': 'Body wight loss (kg)'}, {'measure': 'Plasma Cholesterol', 'timeFrame': 'At baseline, the fourth week and the eighth week of study', 'description': 'The plasma total cholesterol and LDL-C concentrations 12 hours after the subjects had fasted'}, {'measure': 'Plasma proprotein convertase subtilisin/kexin type 9 (PCSK9)', 'timeFrame': 'At baseline and the eighth week of study', 'description': 'The plasma PCSK9 concentration 12 hours after the subjects had fasted'}, {'measure': 'Plasma C-reactive protein', 'timeFrame': 'At baseline and the eighth week of study', 'description': 'The plasma CRP concentration'}, {'measure': 'Plasma Insulin', 'timeFrame': 'At baseline and the eighth week of study', 'description': 'The plasma insulin concentration 12 hours after the subjects had fasted'}, {'measure': 'Blood pressure', 'timeFrame': 'At baseline, the fourth week and the eighth week of study', 'description': 'Systolic and diastolic bliood pressure'}, {'measure': 'Urinary polyphenol', 'timeFrame': 'At baseline, the fourth week and the eighth week of study', 'description': 'Total polyphenol concentration in spot urine sample'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperlipidemias', 'Hypertriglyceridemia']}, 'descriptionModule': {'briefSummary': 'Barberry is a well-documented medicinal plant that is utilized as a feed additive in a variety of food cultures. Barberry is a rich source of antioxidants, minerals, phenolic compounds, and flavonoids. Based on the results of animal and human studies, barberry may have therapeutic and medicinal properties, including the ability to improve blood lipid profile. The present study will investigate the effect of seedless barberry consumption on cardiometabolic factors in overweight or obese individuals with mild to moderate hypertriglyceridemia.', 'detailedDescription': 'This study is an open-label, randomized, controlled clinical trial and will recruit those who are willing to participate and meet the inclusion criteria. Inclusion criteria are fasting serum triglycerides 150-499 mg/dL, body mass index 25-40 kg/m2, age range 18-75 years. Exclusion criteria are regular use of drugs of the fibrate family, regular use of fish oil supplements or omega-3 supplements or flax seed or chia seed, treatment with glucocorticoids, end-stage renal disease. Subjects who agree to participate in the study will be randomly assigned to one of two study groups. All patients in both groups will be prescribed a low-calorie diet. In the first group, 10 grams of powdered seedless barberry will be consumed daily in addition to the low-calorie diet. The second group (control group) will continue with the low calorie diet. The study will last 8 weeks. Patients are asked to refrain from using over-the-counter herbal medicines and dietary supplements during the study. A baseline fasting blood sample, blood pressure measurements, and anthropometric indices will be obtained. Subsequent assessments will be made at four-week and eight-week intervals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fasting serum triglycerides 150-499 mg/dL,\n* Body mass index 25-40 kg/m2\n* Age range 18-75 years\n\nExclusion Criteria:\n\n* Regular use of drugs of the fibrate family, fish oil supplements or omega-3 supplements\n* Regular consumption of flax seed or chia seed\n* Treatment with glucocorticoids\n* End-stage renal disease'}, 'identificationModule': {'nctId': 'NCT06483932', 'briefTitle': 'Barberry and Cardiometabolic Risk Factors in Individuals With Hypertriglyceridemia', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University'}, 'officialTitle': 'Effect of Dried Barberry Consumption on Cardiometabolic Risk Factors in Individuals With Mild to Moderate Hypertriglyceridemia', 'orgStudyIdInfo': {'id': '43008122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'A diet with a reduced calorie intake', 'interventionNames': ['Other: Low-calorie diet']}, {'type': 'EXPERIMENTAL', 'label': 'Barberry', 'description': 'A diet with a reduced calorie intake, coupled with the consumption of barberry', 'interventionNames': ['Other: Dried barberry', 'Other: Low-calorie diet']}], 'interventions': [{'name': 'Dried barberry', 'type': 'OTHER', 'otherNames': ['Berberis vulgaris'], 'description': 'Subjects will ingest 10 grams of powdered seedless barberry on a daily basis, in conjunction with the low-calorie diet.', 'armGroupLabels': ['Barberry']}, {'name': 'Low-calorie diet', 'type': 'OTHER', 'description': 'Diet with 500 kcal subtracted from the daily energy requirement', 'armGroupLabels': ['Barberry', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kāshān', 'state': 'Isfahan', 'country': 'Iran', 'facility': 'Shahid Beheshty Unversity Hospital', 'geoPoint': {'lat': 34.00228, 'lon': 51.43879}}], 'overallOfficials': [{'name': 'Javad Nasrollahzadeh, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shahid Beheshti University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, {'name': 'Kashan University of Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Javad Nasrollahzadeh', 'investigatorAffiliation': 'Shahid Beheshti University'}}}}