Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-16 @ 3:40 PM
Study NCT ID:
NCT02329067
Status:
COMPLETED
Last Update Posted:
2017-08-29
First Post:
2014-12-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Metabolic Effect of Walnuts in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-28', 'studyFirstSubmitDate': '2014-12-29', 'studyFirstSubmitQcDate': '2014-12-29', 'lastUpdatePostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-HDL-cholesterol', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'LDL-cholesterol', 'timeFrame': '8 weeks'}, {'measure': 'total-cholesterol', 'timeFrame': '8 weeks'}, {'measure': 'apoB', 'timeFrame': '8 weeks'}, {'measure': 'triglycerides', 'timeFrame': '8 weeks'}, {'measure': 'fasting glucose', 'timeFrame': '8 weeks'}, {'measure': 'HOMA index', 'timeFrame': '8 weeks'}, {'measure': 'caloric intake', 'timeFrame': '8 weeks'}, {'measure': 'ratio CH:fat:protein', 'timeFrame': '8 weeks'}, {'measure': 'ratio SFA:MUFA:PUFA', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lipid Metabolism Disorders']}, 'descriptionModule': {'briefSummary': 'The objectives of the proposed study are to assess whether the metabolic effects of walnut consumption depends on which food components the walnuts substitute (i.e. carbohydrates; saturated fatty acids) and whether it is important to consume walnuts as snacks or with meals.', 'detailedDescription': 'The objectives of the proposed study are to assess whether the metabolic effects of walnut consumption depends on which food components the walnuts substitute (i.e. carbohydrates; saturated fatty acids) and whether it is important to consume walnuts as snacks or with meals.\n\nThe metabolic effects of walnut consumption may not only relate to the ingested walnuts but also to what is not eaten when walnuts are consumed. We want to evaluate whether the metabolic changes are more pronounced if study participants are instructed to reduce carbohydrates or saturated fatty acids to remain on an isocaloric diet. In a third group we will test what food is omitted if no specific instructions are given. Furthermore half of the subjects in each group will be instructed to eat walnuts with meals and half as snacks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal healthy women and healthy men\n* Age \\>50 yrs\n* Written informed consent prior to study participation\n\nExclusion Criteria:\n\n* Known allergy to nuts\n* Evidence of alcohol (women \\>70g/week, men \\>140g/week), tabacco or drug abuse\n* Obesity ≥35 kg/m2\n* Diabetes mellitus\n* Hypertension \\>140/90 mmHg or history of hypertension\n* LDL-cholesterol \\>190 mg/dl, Triglycerides \\> 350 mg/dl\n* History of atherosclerotic disease\n* Liver disease of any etiology\n* Kidney disease of any etiology (GFR \\< 60 ml/min/1.73)\n* Uncontrolled thyroid disease or other endocrine diseases\n* Acute or chronic inflammatory diseases\n* Active malignancy\n* Current or previous (within 3 months) treatment with antidiabetic drugs, hypolipidemic drugs, antihypertensive drugs, anti-inflammatory drugs, vitamin E, hormonal replacement therapy\n* major surgical intervention within 3 months (or planned)'}, 'identificationModule': {'nctId': 'NCT02329067', 'acronym': 'WALDI', 'briefTitle': 'The Metabolic Effect of Walnuts in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': 'The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women Substituting Walnuts for Different Food Components', 'orgStudyIdInfo': {'id': 'WALNUT-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'walnut-CH', 'description': 'Western type diet including walnuts (43g/day); Walnuts substitute carbohydrates', 'interventionNames': ['Other: walnuts']}, {'type': 'EXPERIMENTAL', 'label': 'Walnut-SFA', 'description': 'Western type diet including walnuts (43g/day); Walnuts substitute saturated fatty acids', 'interventionNames': ['Other: walnuts']}, {'type': 'EXPERIMENTAL', 'label': 'Walnut-LIB', 'description': 'Western type diet including walnuts (43g/day); no specific recommendation', 'interventionNames': ['Other: walnuts']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Isocaloric western type diet w/o nuts, nut butters or nut oils of any kind'}], 'interventions': [{'name': 'walnuts', 'type': 'OTHER', 'description': 'consumption of 43 g walnuts per day', 'armGroupLabels': ['Walnut-LIB', 'Walnut-SFA', 'walnut-CH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81377', 'city': 'Munich', 'country': 'Germany', 'facility': 'Medical Department 2, University Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Klaus G Parhofer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ludwig-Maximilians - University of Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor of Endocrinology and Metabolism', 'investigatorFullName': 'Klaus Parhofer', 'investigatorAffiliation': 'Ludwig-Maximilians - University of Munich'}}}}