Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT00662766
Status:
COMPLETED
Last Update Posted:
2008-04-21
First Post:
2008-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention With Black Currant Seed Press Residues in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001939', 'term': 'Bread'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-16', 'studyFirstSubmitDate': '2008-04-10', 'studyFirstSubmitQcDate': '2008-04-16', 'lastUpdatePostDateStruct': {'date': '2008-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oxidant/antioxidant status of the test person', 'timeFrame': 'after 1, 5, and 9 weeks'}], 'secondaryOutcomes': [{'measure': 'tocopherol intake, tocopherol faecal excretion and serum tocopherol concentration', 'timeFrame': 'after 1, 5, and 9 weeks'}, {'measure': 'fiber intake and excretion', 'timeFrame': 'after 1, 5, and 9 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Black currant', 'Berry seed', 'Press residue', 'Tocopherol', 'Fatty acids', 'Fiber', 'Total phenols', 'TEAC', 'Comet assay', 'Dihydroxybenzoic acid'], 'conditions': ['Smoking']}, 'referencesModule': {'references': [{'pmid': '19523725', 'type': 'DERIVED', 'citation': 'Helbig D, Wagner A, Schubert R, Jahreis G. Tocopherol isomer pattern in serum and stool of human following consumption of black currant seed press residue administered in whole grain bread. Clin Nutr. 2009 Dec;28(6):662-7. doi: 10.1016/j.clnu.2009.05.003. Epub 2009 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'The study was performed to investigate the effects of the consumption of black currant seed press residues, which were baked into bread.', 'detailedDescription': 'Berry seeds are a by-product of berry fabrication (e. g. to juices or jam). In order to maintain their functionality and long life span, berry seeds need to contain cell stabilizing ingredients such as vitamins and polyphenols. Since it seems to be a valuable source of health beneficial substances in human nutrition, commercial use should be found. Therefore, seeds were pressed (seed press residue), ground and baked into bread for consumption.\n\nBlack currant seed press residues are rich in tocopherols and also contain anthocyanins; both act as antioxidants. Additionally there is 50% fibre in the residue, soluble and insoluble fibre in equal shares.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* discrimination between smoker (\\> 5 cigarets/d) or non-smoker\n\nExclusion Criteria:\n\n* diet during the study\n* serious sport\n* diagnosed diseases\n* use of nutritional supplements'}, 'identificationModule': {'nctId': 'NCT00662766', 'briefTitle': 'Intervention With Black Currant Seed Press Residues in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'University of Jena'}, 'officialTitle': 'Intervention Study on the Health Beneficial Effects of Bread Enriched With Black Currant Seed Press Residues in Healthy Subjects', 'orgStudyIdInfo': {'id': 'LSEP H22-05'}}, 'armsInterventionsModule': {'interventions': [{'name': 'black currant seed press residue', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Black currant seed press residue, baked into bread'}, {'name': 'Bread without black currant seed press residues', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Same bread but without seeds'}, {'name': 'Baseline data', 'type': 'DIETARY_SUPPLEMENT', 'description': 'No supplement was administered.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gerhard Jahreis, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Jena, Dept. of Nutritional Physiology'}, {'name': 'Dorit Helbig, Dipl. troph.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Jena, Dept. of Nutritional Physiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jena', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Prof. Dr. G. Jahreis', 'oldOrganization': 'Universitiy of Jena'}}}}