Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-02-20 @ 10:46 PM
Study NCT ID:
NCT01778257
Status:
COMPLETED
Last Update Posted:
2013-01-29
First Post:
2012-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Mate Extracts on Decrement of Body and Abdominal Fat in Obese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-25', 'studyFirstSubmitDate': '2012-12-07', 'studyFirstSubmitQcDate': '2013-01-25', 'lastUpdatePostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in body and abdominal fat', 'timeFrame': 'body fat: baseline, 6 weeks and 12 weeks, abdominal fat of CT: baseline and 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Changes in anthropometric parameters(weight, BMI, waist and hip circumference)', 'timeFrame': 'baseline, 6 weeks and 12 weeks'}, {'measure': 'Changes in blood lipid profile(total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, free fatty acid)', 'timeFrame': 'baseline, 6 weeks and 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mate extracts', 'Obesity', 'abdominal fat'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '26408319', 'type': 'DERIVED', 'citation': 'Kim SY, Oh MR, Kim MG, Chae HJ, Chae SW. Anti-obesity effects of Yerba Mate (Ilex Paraguariensis): a randomized, double-blind, placebo-controlled clinical trial. BMC Complement Altern Med. 2015 Sep 25;15:338. doi: 10.1186/s12906-015-0859-1.'}]}, 'descriptionModule': {'briefSummary': 'Obesity is a major health issue worldwide; there is a constant raise in obesity related death each year.', 'detailedDescription': 'The primary aim of the study was to investigate the effect of Mate extracts in Korean subjects on body fat and abdominal fat, double blind, placebo-controlled clinical trial.\n\nThirty obesity subjects with BMI ≥ 25 kg/㎡ and waist-hip ratio (WHR)≥ 0.90 for men and ≥ 0.85 for women were for 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Volunteers aged 19 to 65 years\n* 25 kg/m2 ≤ BMI ≥35 kg/m2\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* Significant variation in weight (more 10%) in the past 3 month\n* Cardiovascular disease, neurologic or psychiatric disease, renal, pulmonary and hepatic abnormalities\n* History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease (Crohn's disease) or gastrointestinal surgery (a caesum or enterocele surgery are included)\n* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the sutdy\n* Allergic or hypersensitive to any of the ingredients in the test products\n* Pregnancy or breast feeding\n* Used antipsychosis drugs therapy within past 2 months\n* History of alcohol or substance abuse (21 units/week over)\n* Participation in any other clinical trials within past 3 months"}, 'identificationModule': {'nctId': 'NCT01778257', 'briefTitle': 'Efficacy and Safety of Mate Extracts on Decrement of Body and Abdominal Fat in Obese Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Chonbuk National University Hospital'}, 'officialTitle': 'Mate Extract Supplementation Reduces Body and Abdominal Fat in Obese Korean Subjects', 'orgStudyIdInfo': {'id': 'CUH_2011_GS_MATE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mate extracts group', 'description': 'Mate extract(3150 mg/day)for 12 weeks', 'interventionNames': ['Dietary Supplement: Mate extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo (3150 mg/day) for 12 weeks', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Mate extract', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Extracts of Ilex paraguariensis A. St.-Hil.'], 'description': 'Mate is a South American herb that is traditionally prepared as a tea and used, among others, for weight reduction.', 'armGroupLabels': ['Mate extracts group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Amount and calorie of placebo are same with Mate extracts.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Min-Gul Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonbuk National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonbuk National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'GS Engineering & Construction', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Min-Gul Kim, MD', 'investigatorAffiliation': 'Chonbuk National University Hospital'}}}}