Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT03663127
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2018-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of "Beauty Drink" on Regulation of Blood Pressure Effect by Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2018-09-06', 'studyFirstSubmitQcDate': '2018-09-06', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The changes of blood pressure of the subjects (SBP and DBP)', 'timeFrame': '8 weeks', 'description': 'values change of systolic and diastolic BPs between before to after 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gamma-aminobutyric acid', 'blood pressure', 'clinical trial', 'angiotensin converting enzyme', 'Beauty Drink'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This report assesses the effect of supplementation with gamma-aminobutyric acid on blood pressure among people with mild hypertension. Overall, "Beauty Drink" consumption for 8 weeks could successfully reduce mean diastolic and systolic BP through the suppression of ACE linked to downstream suppression of angiotensin II formation, which further decreases the sympathetic outflow leads to hypertension.', 'detailedDescription': 'This report assesses the effect of supplementation with gamma-aminobutyric acid on blood pressure among people with mild hypertension. Fifty subjects with systolic blood pressure (SBP) between 120 and 159 mm Hg and/or diastolic blood pressure (DBP) between 80 and 99 mm Hg were randomized to ingest 2 bottles of "Beauty Drink" or placebo per day for 8 weeks of a stage. In addition, anthropometric measurements (blood pressure, body weight, body fat) and blood biochemical markers including fasting blood glucose (FBG), albumin, total cholesterol (TC), triglyceride (TG), HDL-C, LDL-C, creatinine (Cr), blood urea nitrogen (BUN), AST, ALT were examined every four weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible subjects were untreated hypertensive men or women aged between 20 and 70 years old with SBP between 120 and 159 mmHg and/or DBP between 80 and 99 mmHg as measured in a sitting position\n\nExclusion Criteria:\n\n* Subjects were excluded if they had a history of major cardiovascular disease or severe liver dysfunction; Diastolic blood pressure ≥ 100 mmHg or Systolic blood pressure ≥ 160 mmHg;\n* Alcoholic;\n* US-controlled diabetics;\n* Stoke in past one year;\n* Mental diseases or melancholia;\n* Pregnancy or breast-feeding a child;\n* Renal dysfunction;'}, 'identificationModule': {'nctId': 'NCT03663127', 'briefTitle': 'Evaluation of "Beauty Drink" on Regulation of Blood Pressure Effect by Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'Evaluation of "Beauty Drink" on Regulation of Blood Pressure Effect by Clinical Trial', 'orgStudyIdInfo': {'id': 'CS18077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Beauty Drink', 'description': 'Subjects receive two bottles "Beauty Drink" per day for 8 weeks of a stage.', 'interventionNames': ['Dietary Supplement: Beauty Drink']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects receive two bottles placebo per day for 8 weeks of a stage.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Beauty Drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects receive two bottles of "Beauty Drink" per day for 8 weeks of a stage. Anthropometric measurements such as blood pressure (systolic blood pressure \\[SBP\\] and diastolic blood pressure \\[DBP\\]), body weight, body fat, waistline, hips, and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST, and ALT were measured every four weeks.', 'armGroupLabels': ['Beauty Drink']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects receive two bottles of placebo of similar appearance per day for 8 weeks of a stage. In addition, anthropometric measurements such as blood pressure (systolic blood pressure \\[SBP\\] and diastolic blood pressure \\[DBP\\]), body weight, body fat, waistline, hips, and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST, and ALT were measured every four weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'You-Cheng Mr Shen, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung Shan Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'You-Cheng Shen', 'investigatorAffiliation': 'Chung Shan Medical University'}}}}