Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-01-10 @ 12:39 AM
Study NCT ID:
NCT01167205
Status:
UNKNOWN
Last Update Posted:
2010-07-22
First Post:
2010-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Positive Effects of Haematococcus Astaxanthin on Oxidative Stress and Lipid Profile in Overweight and Obese Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005948', 'term': 'astaxanthine'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2011-03'}, 'lastUpdateSubmitDate': '2010-07-20', 'studyFirstSubmitDate': '2010-07-08', 'studyFirstSubmitQcDate': '2010-07-20', 'lastUpdatePostDateStruct': {'date': '2010-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the plasma MDA (malonaldehyde) level', 'timeFrame': '12 weeks', 'description': 'MDA is a three chain aldehyde produced during the composition of a lipid hydroperoxide and is a well known indicator of lipid peroxidation.\n\nThe purpose of this stduy is to determine whether ASX supplementation lowers oxidative stress using MDA,a biomarker.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Healthy adults with BMI over 25.0 kg/m2'], 'conditions': ['Healthy', 'Overweight', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether astaxanthin (ASX) supplementation will reduce obesity-induced oxidative stress and improve lipid profile in overweight and obese adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with BMI over 25.0 kg/m2\n* Non-smoker\n\nExclusion Criteria:\n\n* Excessive alcohol consumption\n* Pregnant or lactating women\n* Dyslipidemia, hyperglycemia, or other chronic diseases.\n* Subjects who were taking vitamin supplements'}, 'identificationModule': {'nctId': 'NCT01167205', 'briefTitle': 'Positive Effects of Haematococcus Astaxanthin on Oxidative Stress and Lipid Profile in Overweight and Obese Adults', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'orgStudyIdInfo': {'id': 'C-1005-072-319'}}, 'armsInterventionsModule': {'interventions': [{'name': 'astaxanthin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'astaxanthin 20mg for 12 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Wan Gyoon Shin, Ph D, Pharm D', 'role': 'CONTACT', 'email': 'wgshin@snu.ac.kr', 'phone': '+82 2 740 85556'}], 'facility': 'Clinical Research Institute Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Yeo-kyu Youn, Doctor', 'role': 'CONTACT', 'email': 'ykyoun@snu.ac.kr', 'phone': '+82 2 2072 3447'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health & Welfare, Korea', 'class': 'OTHER_GOV'}]}}}