Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-04-23 @ 9:44 AM
Study NCT ID:
NCT02764957
Status:
COMPLETED
Last Update Posted:
2017-08-28
First Post:
2016-05-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Green Coffee Extract and Metabolic Syndrome
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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-25', 'studyFirstSubmitDate': '2016-05-01', 'studyFirstSubmitQcDate': '2016-05-04', 'lastUpdatePostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fasting blood glucose', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'HOMA-IR', 'timeFrame': '8 weeks'}, {'measure': 'blood pressure', 'timeFrame': '8 weeks'}, {'measure': 'insulin', 'timeFrame': '8 weeks'}, {'measure': 'hemoglubin A1c', 'timeFrame': '8 weeks'}, {'measure': 'triglyceride', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'Metabolic syndrome (Mets) is an assemblage of risk factors which can increase the risk of developing type 2 diabetes mellitus and cardiovascular disease. Green coffee extract (GCE) is derived from unroasted coffee beans and has substantial amounts of polyphenols primarily chlorogenic acids (CGA). It has been shown that GCE and CGA can exert a positive influence over Mets components including blood pressure, blood glucose, inflammation, oxidative stress, insulin resistance and blood lipids. Up to our knowledge no study has been conducted on humans in the field of GCA influences on Mets patients. Therefore, this study is planned to evaluate GCA supplementation effects on anthropometric measurements, glycemic control, blood pressure, lipid profile 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* Waist circumference\\>102 cm in men and \\>88 cm in women\n* Fasting blood glucose\\>100 mg/dL (5.6 mmol /L)\n* Systolic blood pressure\\>130 mmHg or diastolic blood pressure\\>85mmHg\n* Triglycerides\\> 150 mg/dL (1.7 mmol/L)\n\nExclusion Criteria:\n\n* Insulin administration\n* Pregnancy and breastfeeding\n* regular consumption of coffee and green tea'}, 'identificationModule': {'nctId': 'NCT02764957', 'briefTitle': 'Green Coffee Extract and Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'National Nutrition and Food Technology Institute'}, 'officialTitle': 'Effects of Green Coffee Extract Supplementation on Anthropometric Measurements, Glycemic Control, Blood Pressure, Lipid Profile', 'orgStudyIdInfo': {'id': 'NationalNFTI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intervention', 'description': '400 mg green coffee extract capsules twice per day for 8 weeks The Green coffee extract is standardised with 45% total chlorogenic acid by HPLC', 'interventionNames': ['Dietary Supplement: green coffee extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'placebo capsules twice per day for 8 weeks have identical appearance to Green coffee extract capsules and contain starch', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'green coffee extract', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['intervention']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19435', 'city': 'Tehran', 'country': 'Iran', 'facility': 'NNFTRI clinic', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Nutrition and Food Technology Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Azita Hekmatdoost', 'investigatorFullName': 'Dr Azita Hekmatdoost', 'investigatorAffiliation': 'National Nutrition and Food Technology Institute'}}}}