Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT06298318
Status:
COMPLETED
Last Update Posted:
2025-01-22
First Post:
2023-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metabolic Changes in Healthy Subjects with Acute Binge Drink
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063425', 'term': 'Binge Drinking'}, {'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'not involve drug or biologic products'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2023-11-01', 'studyFirstSubmitQcDate': '2024-02-29', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fecal metabolites', 'timeFrame': 'day1-2 of each 0 hour and 24 hours', 'description': 'Gut microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.'}], 'primaryOutcomes': [{'measure': 'hepatic function change', 'timeFrame': 'day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours', 'description': 'Research blood hepatic function include:Alanine Aminotransferase in U/L;Aspartate Aminotransferase in U/L;Gamma-Glutamyltransferase in U/L;Alpha-Fucosidase in U/L;Alkaline Phosphatase in U/L;cholinesterase in U/L;Lactate Dehydrogenase Enzyme in U/LTBIL in μmol/L, direct bilirubin in μmol/L, indirect bilirubin in μmol/L, and total bile acid in μmol/L'}, {'measure': 'Hepatic fibrosis change', 'timeFrame': 'day1-2 of each 0 hour and 1hour and 5 hours and 12 hours and 24 hours', 'description': 'Research blood hepatic fibrosis include:Hyaluronicacid in ng/mL;Laminin in ng/mL;type # in ng/mL;precollagen in ng/ mL;type # collagen in ng/mL;Fibronect in ng/mL'}, {'measure': 'Lipid metabolism change', 'timeFrame': 'day1-2 and of each 0 hour and 1hour and 5 hours and 12 hours and 24 hours', 'description': 'Research blood Fat metabolism include:Triglycerides in mmol/L;HDL-Cholesterol in mmol/L;LDL--Cholesterol in mmol/ L;Apolipoprotein A in mmol/L;Apolipoprotein B in mmol/L;Lipoprotein(a) in mmol/L'}], 'secondaryOutcomes': [{'measure': 'Ethanol concentration', 'timeFrame': 'day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours', 'description': 'Ethanol concentration change in mg/dL of each set'}, {'measure': 'Acetaldehyde concentration', 'timeFrame': 'day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours', 'description': 'Acetaldehyde concentration change in mg/dL of each set'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute alcohol intake', 'Liver'], 'conditions': ['Binge Drinking', 'Liver Injury', 'Hepatic Steatosis']}, 'referencesModule': {'references': [{'pmid': '24458173', 'type': 'BACKGROUND', 'citation': 'Lee MH, Kwak JH, Jeon G, Lee JW, Seo JH, Lee HS, Lee JH. Red ginseng relieves the effects of alcohol consumption and hangover symptoms in healthy men: a randomized crossover study. Food Funct. 2014 Mar;5(3):528-34. doi: 10.1039/c3fo60481k.'}, {'pmid': '28750942', 'type': 'BACKGROUND', 'citation': 'Kim H, Kim YJ, Jeong HY, Kim JY, Choi EK, Chae SW, Kwon O. A standardized extract of the fruit of Hovenia dulcis alleviated alcohol-induced hangover in healthy subjects with heterozygous ALDH2: A randomized, controlled, crossover trial. J Ethnopharmacol. 2017 Sep 14;209:167-174. doi: 10.1016/j.jep.2017.07.028. Epub 2017 Jul 24.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this double-blinded, randomized trial is to investigate the effects of acute binge drinking on liver function, liver fat content, and lipid metabolism in healthy young subjects. The main questions it aims to answer are:\n\n1\\. If acute binge drinking could alleviate liver injury and hepatic steatosis.', 'detailedDescription': 'The goal of this double-blinded, randomized trial is to investigate the effects of acute binge drinking on liver function, liver fat content, and lipid metabolism in healthy young subjects. The main questions it aims to answer are:\n\n1\\. If acute binge drinking could alleviate liver injury and hepatic steatosis.\n\nParticipants will be randomized into two groups (n=40) and provided vodka (1 g/kg body weight) or an equal amount of non-alcoholic beverages with the same taste and colour but without alcohol, respectively. 15 minutes later, they are successively provided with the same breakfast. Venous blood samples were collected at 0h, 1h, 3h, 5h, 6h, 12h, and 24h from each subject, respectively.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. male aged 18-30 years;\n2. body mass index (BMI) ranging from 18.5 to 28 kg/m²;\n3. having prior experience with binge drinking or hangovers, as assessed using the Personal Assessment of Maximum Drinking Capacity Survey Questionnaire\n\nExclusion criteria\n\n1. with alcohol intolerance or alcohol dependence;\n2. with serious health conditions, such as liver, kidney, cardiovascular, or gastrointestinal diseases;\n3. vegetarians;\n4. smokers;\n5. with a history of drug use, including antihistamines, antihypertensives, antidiabetics, anxiolytics, and central nervous system depressants;\n6. who had used antibiotics within two weeks prior to the trial;\n7. who had consumed alcohol, alcoholic beverages or alcohol-containing foods within one week before the trial.'}, 'identificationModule': {'nctId': 'NCT06298318', 'acronym': 'MeABD', 'briefTitle': 'Metabolic Changes in Healthy Subjects with Acute Binge Drink', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zhejiang Chinese Medical University'}, 'officialTitle': 'Effect of Acute Binge Drink Intervention on Healthy Young Subjects: a Double-blinded, Randomized Trial', 'orgStudyIdInfo': {'id': 'Acute Binge Drink'}, 'secondaryIdInfos': [{'id': 'NSFC: 82273625', 'type': 'OTHER_GRANT', 'domain': 'National Natural Science Foundation of China'}, {'id': 'ZCLY24H2602', 'type': 'OTHER_GRANT', 'domain': 'Natural Science Foundation of Zhejiang Province'}, {'id': '202410344043', 'type': 'OTHER_GRANT', 'domain': 'National Project for Innovation and Entrepreneurship Training Program for College Students'}, {'id': '202410344075X', 'type': 'OTHER_GRANT', 'domain': 'National Project for Innovation and Entrepreneurship Training Program for College Students'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'BMI: if 18.5 ≤ BMI \\< 24.0, individuals received 1.0 g/kg body weight of water; if 24.0 ≤ BMI ≤ 28.0, individuals received 0.8 g/kg body weight of water.', 'interventionNames': ['Other: water']}, {'type': 'EXPERIMENTAL', 'label': 'vodka group', 'description': 'BMI: if 18.5 ≤ BMI \\< 24.0, individuals received 1.0 g/kg body weight of vodka; if 24.0 ≤ BMI ≤ 28.0, individuals received 0.8 g/kg body weight of vodka.', 'interventionNames': ['Other: Vodka']}], 'interventions': [{'name': 'Vodka', 'type': 'OTHER', 'description': 'BMI: if 18.5 ≤ BMI \\< 24.0, individuals received 1.0 g/kg body weight of vodka; if 24.0 ≤ BMI ≤ 28.0, individuals received 0.8 g/kg body weight of vodka.', 'armGroupLabels': ['vodka group']}, {'name': 'water', 'type': 'OTHER', 'description': 'equal amount of non-alcoholic beverages with the same taste and colour but without alcohol', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310053', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Chinese Medical University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'guiiqin sun', 'role': 'STUDY_CHAIR', 'affiliation': 'Zhejiang Chinese Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Protect volunteers' personal health data and personal privacy"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Chinese Medical University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Li Lab,MD', 'investigatorAffiliation': 'Zhejiang Chinese Medical University'}}}}