Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 11:08 PM
Study NCT ID:
NCT03514667
Status:
UNKNOWN
Last Update Posted:
2018-07-31
First Post:
2018-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Nanocurcumin on Serum Oxidative Stress,Inflammation,Adiponectin and NF-kB in Blood Mononuclear Cells in Metabolic Syndrome Patients (Nuclear Factor-κB)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2020-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-29', 'studyFirstSubmitDate': '2018-04-20', 'studyFirstSubmitQcDate': '2018-04-20', 'lastUpdatePostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Total antioxidant capacity (TAC)', 'timeFrame': '12 weeks'}, {'measure': 'Serum Malondialdehyde (MDA)', 'timeFrame': '12weeks'}, {'measure': 'Serum C-reactive protein (CRP)', 'timeFrame': '12weeks'}, {'measure': 'Serum Adiponectin', 'timeFrame': '12weeks'}, {'measure': 'NF-kB(p65) transcription in PBMC', 'timeFrame': '12weeks'}, {'measure': 'Serum curcumin', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'Metabolic syndrome is a public health challenge that includes a range of conditions including abdominal obesity, dyslipidemia, hyperglycemia, and hypertension. The syndrome is associated with an increase in the risk of Cardiovascular disease and death. Curcumin is a very active compound obtained from turmeric root. Curcumin has antioxidant and anti-inflammatory effects, and is also involved in the regulation of several signaling pathways. Since curcumin powder has low bioavailability, fast metabolism and low absorption, nanomicielle curcumin will be used in this study. Therefore, this study is planned to determine the effects of supplementation of nanomicielle curcumin on oxidative stress, systemic inflammation, adiponectin in serum and NF-kB in peripheral blood mononuclear cells in patients with metabolic syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 25\\<body mass index \\>40\n* waist circumference \\>102 cm in men or \\>88 cm in women\n* Fasting blood glucose \\>100 mg/dL\n* Triglycerides (TG) \\> 150 mg/dL\n* High density lipoprotein cholesterol (HDL-C) \\<50 in women or \\<40 in men\n* Systolic blood pressure (SBP) \\>130 mmHg and diastolic blood pressure (DBP) \\>85mmHg\n\nExclusion Criteria:\n\n* insulin administration for diabetes control\n* hypo- or hyperthyroidism,\n* renal failure or other chronic diseases\n* pregnancy and breastfeeding\n* taking weight loss supplements and obeying unusual weight loss plans'}, 'identificationModule': {'nctId': 'NCT03514667', 'briefTitle': 'The Effects of Nanocurcumin on Serum Oxidative Stress,Inflammation,Adiponectin and NF-kB in Blood Mononuclear Cells in Metabolic Syndrome Patients (Nuclear Factor-κB)', 'organization': {'class': 'OTHER', 'fullName': 'National Nutrition and Food Technology Institute'}, 'officialTitle': 'The Effects of Nanomicielle Curcumin on Oxidative Stress, Systemic Inflammation, Adiponectin in Serum and NF-kB in Blood Mononuclear Cells, in Patients With Metabolic Syndrome', 'orgStudyIdInfo': {'id': '188'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intervention group', 'description': '80 mg nanomicielle curcumin capsules once a day for 12 weeks', 'interventionNames': ['Dietary Supplement: nanomicielle curcumin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'placebo capsules once a day for 12 weeks', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'nanomicielle curcumin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will be selected from those referring to endocrinology clinics of Shohadaye YaftAbad and Pars Hospital (Tehran, Iran) who meet the inclusion criteria. Each subject will give informed written consent to participate in the study. 10 cc fasting blood samples will be collected from each subject at baseline and at the end of trial. Anthropometric parameters will be measured.In order to control the confounding factors in patients, they will be randomly assigned to receive either nanomicielle curcumin or placebo. nanomicielle curcumin and placebo supplements will be provided from the Elixir Nano Sina Company the patients will advise not to change their lifestyle during the study.', 'armGroupLabels': ['intervention group']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will be selected from those referring to endocrinology clinics of Shohadaye YaftAbad and Pars Hospital (Tehran, Iran) who meet the inclusion criteria. Each subject will give informed written consent to participate in the study. 10 cc fasting blood samples will be collected from each subject at baseline and at the end of trial. Anthropometric parameters will be measured.In order to control the confounding factors in patients, they will be randomly assigned to receive either nanomicielle curcumin or placebo. nanomicielle curcumin and placebo supplements will be provided from the Elixir Nano Sina Company the patients will advise not to change their lifestyle during the study.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'state': 'National Nutrition and Food Technology Research Institute', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'golbon sohrab, ph.D', 'role': 'CONTACT', 'email': 'golbonsohrab@yahoo.com', 'phone': '009802122077424'}, {'name': 'zohre bateni', 'role': 'CONTACT', 'email': 'zohre.bateni@yahoo.com', 'phone': '009809129626018'}], 'facility': 'Golbon Sohrab', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Nutrition and Food Technology Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical professor', 'investigatorFullName': 'Dr Azita Hekmatdoost', 'investigatorAffiliation': 'National Nutrition and Food Technology Institute'}}}}