Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-28 @ 2:26 PM
Study NCT ID:
NCT01075568
Status:
UNKNOWN
Last Update Posted:
2010-03-03
First Post:
2010-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Satiety Effect After Okara Compared to Porridge Eating
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-03-02', 'studyFirstSubmitDate': '2010-02-17', 'studyFirstSubmitQcDate': '2010-02-24', 'lastUpdatePostDateStruct': {'date': '2010-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To examine the satiety effect after 48 gram Okara compared to 40 gram of porridge eating.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy People']}, 'descriptionModule': {'briefSummary': 'To examine the satiety effect after eating of Okara.', 'detailedDescription': 'This will be a single blind, cross-over design. Study population will include 10 subjects. The patients will be randomly assigned to receive one of two meals, 48 gram Okara or 40 gram (similar caloric value) semolina in two occasions (two visits). After the eating, the subject will stay in a closed room, without watch or any irritation. After three hours, the patient will fill a VAS questionnaire, and will get a standard meal. The meal will be weighed before and after.\n\nOkara is a natural water extracted food grade soy product, contains approximately 35% protein (mfb), and about 43% of dietary fibers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n* Age 20-65 years old\n* Written Informed Consent\n\nExclusion Criteria:\n\n* History of gastro-intestinal surgery\n* On medication that may influence gastric emptying, or medication for weight loss\n* Patient on PPI treatment, H2 Blockers or medication for weight loss\n* Known allergies to soy\n* Pregnancy or breast-feeding\n* Smoking\n* Athletes\n* Metabolic syndrome or diabetes mellitus\n* Family history of metabolic syndrome or diabetes mellitus\n* Weight loss \\> 2 kg during two months before the study'}, 'identificationModule': {'nctId': 'NCT01075568', 'briefTitle': 'The Satiety Effect After Okara Compared to Porridge Eating', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'orgStudyIdInfo': {'id': 'TASMC-10-NV-016-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Nutrigal Okara - 100', 'type': 'DIETARY_SUPPLEMENT'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'contacts': [{'name': "Nachum Vaisman, Prof'", 'role': 'CONTACT', 'email': 'vaisman@tasmc.health.gov.il', 'phone': '00-972-3-6974807'}], 'facility': 'Tel Aviv Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': "Nachum Vaisman, Prof'", 'role': 'CONTACT', 'email': 'vaisman@tasmc.health.gov.il', 'phone': '009-972-3-6974807'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Nutrigal LTD', 'class': 'UNKNOWN'}]}}}