Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT03409705
Status:
COMPLETED
Last Update Posted:
2019-02-20
First Post:
2018-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Skate Skin Extract on Body Fat in Overweight Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-18', 'studyFirstSubmitDate': '2018-01-10', 'studyFirstSubmitQcDate': '2018-01-17', 'lastUpdatePostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body fat percent', 'timeFrame': 'Change from baseline body fat percent at 6, 12 weeks', 'description': 'Measured by DEXA'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Body Fat']}, 'descriptionModule': {'briefSummary': 'Comparison of a randomized, double-blind, and control-group study for the effect of oral ingestion of low-molecular collagen peptides derived from Skate Skin on body fat reduction in adults', 'detailedDescription': 'Our aim is to investigate the effect of oral ingestion of low-molecular collagen peptides derived from Skate Skin on body fat reduction in adults by a randomized, double-blind, and control-group study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 23\\~30 kg/m2\n\nExclusion Criteria:\n\n* Within the last 6 months, severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease(Angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant diseases (however, although subjects have a history of cerebrovascular disease and heart disease, they can be included if their status are clinically stable)\n* Patients with uncontrolled hypertension (blood pressure greater than 160/100 mmHg)\n* Diabetic patients with poor glycemic control with a fasting blood glucose of 160 mg/dl or more\n* Those who are treated with hypothyroidism or hyperthyroidism\n* Creatinine levels: more than twice the normal upper limit\n* AST (GOT) or ALT (GPT) levels: more than twice the normal upper limit\n* Those complaining of severe gastrointestinal symptoms such as heartburn and indigestion\n* Drugs that affect weight within the last month (absorption inhibitors and Appetite suppressant, health food / supplements related to obesity improvement, psychiatric Drugs, beta blockers, diuretics, birth control pills, steroids, female hormones) If you are taking\n* Participated in the commercial obesity program within the last 3 months.\n* If you have participated or are planning to participate in another clinical trial within the past month If yes\n* Alcohol abuser\n* Smoking abstinence within 3 months\n* If they are pregnant or lactating or have a pregnancy plan during the clinical trial\n* Those with allergic reactions to the constituent food\n* Any person deemed inappropriate by the researcher for other reasons'}, 'identificationModule': {'nctId': 'NCT03409705', 'briefTitle': 'Effect of Skate Skin Extract on Body Fat in Overweight Adults', 'organization': {'class': 'OTHER', 'fullName': 'Pusan National University Yangsan Hospital'}, 'officialTitle': 'Effect of Skate Skin Extract on Body Fat in Overweight Adults: A RCT', 'orgStudyIdInfo': {'id': '02-2017-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Skate Skin group', 'description': '2,000 mg of low-molecular collagen peptide was orally administered per day for 12 weeks.', 'interventionNames': ['Dietary Supplement: Skate Skin group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': '2,000 mg of placebo was orally administered per day for 12 weeks.', 'interventionNames': ['Dietary Supplement: Control group']}], 'interventions': [{'name': 'Skate Skin group', 'type': 'DIETARY_SUPPLEMENT', 'description': '2,000 mg of low-molecular collagen peptide was orally administered per day for 12 weeks.', 'armGroupLabels': ['Skate Skin group']}, {'name': 'Control group', 'type': 'DIETARY_SUPPLEMENT', 'description': '2,000 mg of starch was orally administered per day for 12 weeks.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50612', 'city': 'Yangsan', 'state': 'Gyeungsangnam-do', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'overallOfficials': [{'name': 'Sang Yeoup Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pusan National University Yangsan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pusan National University Yangsan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Professor, Head of Integrated Research Institute for Natural Ingredients and Functional Foods (IRINIF)', 'investigatorFullName': 'Sang Yeoup Lee', 'investigatorAffiliation': 'Pusan National University Yangsan Hospital'}}}}