Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2026-01-01 @ 8:33 AM
Study NCT ID:
NCT01389492
Status:
COMPLETED
Last Update Posted:
2011-07-08
First Post:
2011-07-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Meat and Food Drived Polyphenols on Oxidize LDL Level
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-06', 'studyFirstSubmitDate': '2011-07-03', 'studyFirstSubmitQcDate': '2011-07-06', 'lastUpdatePostDateStruct': {'date': '2011-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in plasma MDA levels following meat meal', 'timeFrame': 'Fasting before meal and 3, and 6 h postprandial, and fasting levels', 'description': 'After an overnight fast baseline (0 h) fasting blood sample (10 ml) was collected in EDTA-treated tubes. The subjects then ate a test meal within 30 min. Blood samples (10 ml) were drawn 3 and 6 h after the meal was eaten. Serum was separated from whole blood by centrifugation (910 g, 15 min), and MDA was evaluated by HPLC in plasma samples'}, {'measure': 'Changes in MDA concentration on LDL fraction following meat meals', 'timeFrame': 'Fasting, before meal was eaten, 3 h following meal, at day 4, 3 h following meal consumption, and day 5 following over nigth fast', 'description': 'Subject consumed the test meals for 4 days. Day 1, (0 h) fasting blood sample (10 ml) was collected in EDTA-treated tubes. The sbjects then ate a test meal within 30 min. Blood samples (10 ml) were drawn 3 h after the meal was eaten. Blood was collected at day 4, 3 h after the meal was eaten, at the morning of day 5.Plasma LDL was isolated using a single discontinuous density gradient ultracentrifugation. The protein concentration was determined based on the method of Bradford. MDA concentration was evaluated by HPLC.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['meat', 'LDL', 'MDA'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The postprandial increase in MDA level following meat meal could cause modification to LDL particles in healthy volunteers. Co-consumption of food drived polyphenols with the meat will result in a significant decrease in LDL modification.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults, normal BMI\n\nExclusion Criteria:\n\n* Metabolic disorders\n* Smokers\n* Drinkers\n* Taking nutritional supplement'}, 'identificationModule': {'nctId': 'NCT01389492', 'briefTitle': 'The Effect of Meat and Food Drived Polyphenols on Oxidize LDL Level', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Nutritional Study:The Effect of Meat and Food Drived Polyphenols on Oxidize LDL Level', 'orgStudyIdInfo': {'id': 'MWPP09-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'frozen meat', 'description': '250 g of frozen meat meal for 4 days', 'interventionNames': ['Other: frozen meat cutlets meal', 'Other: meat meals']}, {'type': 'OTHER', 'label': 'frozen meat and wine', 'description': '250 g of frozen meat and red wine for 4 days', 'interventionNames': ['Other: frozen meat cutlets meal', 'Other: meat meals']}, {'type': 'OTHER', 'label': 'fresh meat', 'description': '250 g of fresh meat meal', 'interventionNames': ['Other: frozen meat cutlets meal', 'Other: meat meals']}, {'type': 'OTHER', 'label': 'fresh meat and wine', 'description': '250 g of fresh meat meal', 'interventionNames': ['Other: frozen meat cutlets meal', 'Other: meat meals']}], 'interventions': [{'name': 'frozen meat cutlets meal', 'type': 'OTHER', 'description': '250 g of meat cutlets', 'armGroupLabels': ['fresh meat', 'fresh meat and wine', 'frozen meat', 'frozen meat and wine']}, {'name': 'meat meals', 'type': 'OTHER', 'description': '250 g of meat meal for 4 days', 'armGroupLabels': ['fresh meat', 'fresh meat and wine', 'frozen meat', 'frozen meat and wine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'The Hebrew University of Jerusalem', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Shlomit Gorelik, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hebrew University of Jerusalem'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Daniel Schurr', 'oldOrganization': 'Hadassah Medical Organization'}}}}