Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-01-04 @ 4:47 PM
Study NCT ID:
NCT03395561
Status:
UNKNOWN
Last Update Posted:
2018-01-10
First Post:
2017-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Green Coffee Extract Supplementation on Adropin, Irisin, Vaspine,Systemic Inflammation and Oxidative Stress in Breast Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2019-10-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-03', 'studyFirstSubmitDate': '2017-12-26', 'studyFirstSubmitQcDate': '2018-01-03', 'lastUpdatePostDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor necrosis factor alpha', 'timeFrame': '12 weeks', 'description': 'assessed by ELISA'}, {'measure': 'Interleukin 6', 'timeFrame': '12 weeks', 'description': 'assessed by ELISA'}], 'secondaryOutcomes': [{'measure': 'body mass index', 'timeFrame': '12 weeks', 'description': 'The body mass index (BMI) or Quetelet index is a value derived from the mass (weight) and height of an individual. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer Survivors']}, 'descriptionModule': {'briefSummary': "To study the effects of green coffee supplement on adropin, irisin, vaspine, systemic inflammation and oxidative stress in breast cancer survivors.50 breast cancer survivors who their treatment is over and referred to follow breast cancer clinic with will be randomly allocated to receive placebos or 2 capsules green coffe for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, adropin, irisin, vaspine, systemic inflammation and oxidative stress will be assessed and compared between groups."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 18 to 70 years\n* Body Mass Index (BMI) between 25-40 treatment is over\n\nExclusion Criteria:\n\n* Taking any kind of supplement for weight reduction\n* pregnancy or lactation\n* Professional athletes'}, 'identificationModule': {'nctId': 'NCT03395561', 'briefTitle': 'Effects of Green Coffee Extract Supplementation on Adropin, Irisin, Vaspine,Systemic Inflammation and Oxidative Stress in Breast Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'National Nutrition and Food Technology Institute'}, 'officialTitle': 'the Evaluation of Green Coffee Extract Supplementation on Adropin, Irisin, Vaspine,Systemic Inflammation and Oxidative Stress in Breast Cancer Survivors', 'orgStudyIdInfo': {'id': '811'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'green coffe', 'description': '2 capsuls of green coffe', 'interventionNames': ['Dietary Supplement: green coffee']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': '2 capsuls', 'interventionNames': ['Other: control']}], 'interventions': [{'name': 'green coffee', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 capsuls', 'armGroupLabels': ['green coffe']}, {'name': 'control', 'type': 'OTHER', 'description': '2 capsuls', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'status': 'RECRUITING', 'country': 'Iran', 'facility': 'National Nutrition and Food Technology Research Institute', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Ehsan Hejazi, PhD', 'role': 'CONTACT', 'email': 'ehsanhejazi@gmail.com', 'phone': '+98-21-22077424'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Nutrition and Food Technology Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr Azita Hekmatdoost', 'investigatorAffiliation': 'National Nutrition and Food Technology Institute'}}}}