Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-04 @ 4:55 PM
Study NCT ID:
NCT00524550
Status:
COMPLETED
Last Update Posted:
2010-08-12
First Post:
2007-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postprandial Insulin Secretion and Appetite Regulation After Moderate Alcohol Consumption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D004467', 'term': 'Economics'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-11', 'studyFirstSubmitDate': '2007-08-30', 'studyFirstSubmitQcDate': '2007-08-31', 'lastUpdatePostDateStruct': {'date': '2010-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pancreatic beta-cell function', 'timeFrame': '3 weeks of treatment preceded by a 1-week wash-out'}, {'measure': 'Satiety', 'timeFrame': '3 weeks of treatment preceded by a 1-week wash-out'}], 'secondaryOutcomes': [{'measure': 'Kinetics of adiponectin', 'timeFrame': '3 weeks of treatment preceded by a 1-week wash-out'}]}, 'conditionsModule': {'keywords': ['Moderate alcohol consumption', 'insulin secretion', 'insulin sensitivity', 'Beta-cell function', 'Adiponectin', 'Appetite', 'Satiety', 'Alcohol-induced gene expression', 'Endocannabinoids', 'Glucose metabolism', 'Lipid metabolism', 'Ratio HMW/total adiponectin', 'Appetite regulation', 'Alcohol-induced adiponectin increase'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '20546561', 'type': 'RESULT', 'citation': 'Joosten MM, Balvers MG, Verhoeckx KC, Hendriks HF, Witkamp RF. Plasma anandamide and other N-acylethanolamines are correlated with their corresponding free fatty acid levels under both fasting and non-fasting conditions in women. Nutr Metab (Lond). 2010 Jun 14;7:49. doi: 10.1186/1743-7075-7-49.'}, {'pmid': '24548643', 'type': 'DERIVED', 'citation': 'Joosten MM, Schrieks IC, Hendriks HF. Effect of moderate alcohol consumption on fetuin-A levels in men and women: post-hoc analyses of three open-label randomized crossover trials. Diabetol Metab Syndr. 2014 Feb 18;6(1):24. doi: 10.1186/1758-5996-6-24.'}, {'pmid': '21353262', 'type': 'DERIVED', 'citation': 'Joosten MM, Witkamp RF, Hendriks HF. Alterations in total and high-molecular-weight adiponectin after 3 weeks of moderate alcohol consumption in premenopausal women. Metabolism. 2011 Aug;60(8):1058-63. doi: 10.1016/j.metabol.2011.01.001. Epub 2011 Feb 24.'}], 'seeAlsoLinks': [{'url': 'http://www.nutritionandmetabolism.com/content/7/1/49', 'label': 'publication'}]}, 'descriptionModule': {'briefSummary': 'A body of epidemiologic studies show that moderate alcohol consumption is associated with a protective effect against type 2 diabetes. The importance of both insulin sensitivity and insulin secretion in the pathogenesis of glucose intolerance and diabetes type 2 is widely recognized. Clinical studies show improved insulin sensitivity after a period of alcohol consumption compared to abstention. However, postprandial insulin secretion and beta-cell function after a period of moderate alcohol consumption have scarcely been addressed in published literature.\n\nWhen consumed as an aperitif or with a meal, alcohol is generally expected to stimulate appetite and food intake and thus might be a risk factor for over consumption and obesity. However the physiological mechanisms for this observed effect are not well understood. Furthermore, previous studies lacked a link between physiological parameters and subjective parameters of satiety.', 'detailedDescription': 'Objective:\n\nPrimary objectives are to study the effects of moderate alcohol consumption on\n\n* Postprandial insulin secretion and pancreatic beta-cell function\n* Physiological and subjective parameters related to satiety and appetite\n\nSecondary objectives are to study the effects of moderate alcohol consumption on\n\n* Miscellaneous markers of glucose homeostasis and insulin sensitivity\n* Kinetics of alcohol-induced increase of adiponectin\n\nA tertiary objective is to study the effects of moderate alcohol consumption on\n\n* Gene expression in subcutaneous adipose tissue in normal-weight pre menopausal women with normal fasting plasma glucose.\n\nStudy design: Randomized, partially controlled, open label, cross-over study with a one week wash-out preceding each treatment period\n\nStudy population: 24 apparently healthy pre menopausal Caucasian women with fasting blood glucose \\<6.1 mmol/L, aged 20 - 44 years at inclusion of the study, with a BMI of 19 - 25 kg/m2, who use oral contraceptives will participate in the study.\n\nIntervention: Participants will drink daily a test substance for three weeks (2 cans of Amstel beer per day; 66 cL \\~ 26 gram alcohol) followed by a reference substance (2 cans of Amstel alcohol-free beer per day; 66 cL \\< 0.5 gram of alcohol) for three weeks or vice versa. Both treatments are preceded by a one-week wash-out period in which no alcohol is consumed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Apparently Females between 20 - 44 years of age\n* Using oral contraceptives for \\>3 months (only phase 1 or 2 oral contraceptives)\n* Normal fasting glucose levels as indicated by venous fasting plasma glucose levels \\< 6.1 mmol/L\n* Alcohol consumption more or equal then 5 and less than 22 glasses/week\n* Body Mass Index (BMI) between 19 and 25 kg/m2\n\nExclusion Criteria:\n\n* Having the intention to become pregnant, to be pregnant or to lactate during the study\n* Having a history of medical or surgical events that may significantly affect the study outcome including metabolic or endocrine disease, gastro-intestinal disorder, or eating behavior disorders such as anorexia/bulimia disorders\n* Having a family history of alcoholism\n* Smoking\n* Reported use of any soft or hard drugs\n* Reported unexplained weight loss or gain of \\> 3 kg in the month prior to the screening'}, 'identificationModule': {'nctId': 'NCT00524550', 'briefTitle': 'Postprandial Insulin Secretion and Appetite Regulation After Moderate Alcohol Consumption', 'organization': {'class': 'OTHER', 'fullName': 'TNO'}, 'officialTitle': 'Effect of Moderate Alcohol Consumption on Postprandial Insulin Secretion, Appetite Regulation, Glucose Homeostasis and Insulin Resistance.', 'orgStudyIdInfo': {'id': 'P7573'}, 'secondaryIdInfos': [{'id': 'Alcohol Research 21'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'moderate alcohol consumption', 'type': 'DIETARY_SUPPLEMENT', 'description': 'drinking commercially available alcohol-free beer or beer (26 grams of alcohol per day), for three weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3700AJ', 'city': 'Zeist', 'state': 'Utrecht', 'country': 'Netherlands', 'facility': 'TNO Quality of Life', 'geoPoint': {'lat': 52.09, 'lon': 5.23333}}], 'overallOfficials': [{'name': 'Henk FJ Hendriks, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hendriks HFJ'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TNO', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'henk FJ Hendriks', 'oldOrganization': 'TNO Quality of life'}}}}