Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT01188902
Status:
COMPLETED
Last Update Posted:
2013-01-08
First Post:
2010-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624464', 'term': 'PR-10 protein, walnut birch pollen'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-07', 'studyFirstSubmitDate': '2010-08-25', 'studyFirstSubmitQcDate': '2010-08-25', 'lastUpdatePostDateStruct': {'date': '2013-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting non-HDL-cholesterol', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'area under the triglyceride curve (AUC-TG)', 'timeFrame': '8 weeks', 'description': 'area under the plasma triglyceride concentration curve following a standardized oral fat challenge'}, {'measure': 'incremental area under the triglyceride curve (iAUC-TG)', 'timeFrame': '8 weeks', 'description': 'incremental area under the plasma triglyceride concentration curve following a standardized oral fat challenge'}, {'measure': 'LDL-cholesterol', 'timeFrame': '8 weeks', 'description': 'fasting plasma LDL-cholesterol concentration'}, {'measure': 'HDL-cholesterol', 'timeFrame': '8 weeks', 'description': 'fasting plasma HDL-cholesterol concentration'}, {'measure': 'triglyceride', 'timeFrame': '8 weeks', 'description': 'fasting plasma triglyceride concentration'}, {'measure': 'glucose', 'timeFrame': '8 weeks', 'description': 'fasting plasma glucose concentration'}, {'measure': 'HOMA', 'timeFrame': '8 weeks'}, {'measure': 'insulin', 'timeFrame': '8 weeks'}, {'measure': 'HbA1c', 'timeFrame': '8 weeks'}, {'measure': 'area under the glucose curve (AUC-glucose)', 'timeFrame': '8 weeks', 'description': 'area under the plasma glucose concentration curve following a standardized oral challenge'}, {'measure': 'area under the insulin curve (AUC-insulin)', 'timeFrame': '8 weeks', 'description': 'area under the plasma insulin concentration curve following a standardized oral challenge'}, {'measure': 'endothelial function', 'timeFrame': '8 weeks', 'description': 'Postprandial (mixed meal challenge) endothelial function (flow mediated dilatation, flow-independent dilatation)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objectives of the proposed study are to assess the effect of walnut consumption on parameters of lipid metabolism, glucose metabolism, incretins and adipokines, endothelial function and blood pressure in healthy men and healthy postmenopausal women'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal healthy women and healthy men\n* Age \\> 50 yrs\n\nExclusion Criteria:\n\n* Evidence of alcohol, tabacco or drug abuse\n* Obesity ≥ 35 kg/m2\n* Diabetes mellitus\n* Hypertension\n* LDL-cholesterol \\> 190 mg/dl, Triglycerides \\> 350 mg/dl\n* History of atherosclerotic disease'}, 'identificationModule': {'nctId': 'NCT01188902', 'briefTitle': 'The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': 'The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women', 'orgStudyIdInfo': {'id': 'Walnut-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'walnut', 'description': 'western type diet with 48 g walnut per day', 'interventionNames': ['Dietary Supplement: walnut']}, {'type': 'NO_INTERVENTION', 'label': 'control'}], 'interventions': [{'name': 'walnut', 'type': 'DIETARY_SUPPLEMENT', 'description': 'walnut consumption 48 g/d', 'armGroupLabels': ['walnut']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81377', 'city': 'Munich', 'country': 'Germany', 'facility': 'Med Dept. 2 Grosshadern', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Klaus Parhofer', 'investigatorAffiliation': 'Ludwig-Maximilians - University of Munich'}}}}