Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2026-01-25 @ 5:40 AM
Study NCT ID:
NCT00738166
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2008-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Content, Bioavailability and Health Effects of Trace Elements and Bioactive Components in Organic Agricultural Systems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D003226', 'term': 'Congresses as Topic'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-27', 'studyFirstSubmitDate': '2008-08-19', 'studyFirstSubmitQcDate': '2008-08-19', 'lastUpdatePostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'miRNA', 'timeFrame': '1 year'}], 'primaryOutcomes': [{'measure': 'Bioavailability of trace elements and secondary metabolites', 'timeFrame': '3 x 12 days'}], 'secondaryOutcomes': [{'measure': 'Health factors', 'timeFrame': '3 x 12 days'}]}, 'conditionsModule': {'keywords': ['diet, organic, health', 'healthy people'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Trace elements, bioactive secondary metabolites and vitamins are among the most important quality parameters in plants. Yet, very little information is available on their content, bioavailability and health effects of organically grown plant food products. The main objective of the project is to study the impact of different agricultural management practises relevant for organic farming on the ability of cereal and vegetable crops to absorb trace elements from the soil and to synthesise bioactive compounds (secondary metabolites, antioxidant vitamins and phytates) with health promoting effects. Field experiments with a rigidly controlled design will be implemented together with state-of-the-art analytical techniques allowing solid conclusions to be drawn on the variability and optimum levels of bioactive compounds. The multitude of analytical data from plant and soil samples will be analysed by multivariate statistical methods in order to reveal differences between the cultivation systems used. Finally, the relationship between bioavailability of the nutrients studied and the elemental fingerprint of plants will be extracted by the statistical methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults aged 18-45 years\n* BMI 20-30 kg/m2\n* Non-vegetarian\n\nExclusion Criteria:\n\n* Physical activity \\> 10 h/week\n* Intake of dietary supplements\n* Regular use of drugs\n* Chronic diseases\n* Smoking\n* Excessive intake of alcohol'}, 'identificationModule': {'nctId': 'NCT00738166', 'acronym': 'OrgTrace', 'briefTitle': 'Content, Bioavailability and Health Effects of Trace Elements and Bioactive Components in Organic Agricultural Systems', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'orgStudyIdInfo': {'id': 'H-C-2007-0078'}, 'secondaryIdInfos': [{'id': 'M194'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'II', 'description': 'organic animal manure', 'interventionNames': ['Other: Organic or conventional diet', 'Other: Diet (organic or conventional)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'III', 'description': 'conventional', 'interventionNames': ['Other: Organic or conventional diet', 'Other: Diet (organic or conventional)']}, {'type': 'EXPERIMENTAL', 'label': 'I', 'description': 'organic green manure', 'interventionNames': ['Other: Organic or conventional diet', 'Other: Diet (organic or conventional)']}], 'interventions': [{'name': 'Organic or conventional diet', 'type': 'OTHER', 'description': '12 days on fully controlled organic 1 diet, organic 2 diet and conventional diet', 'armGroupLabels': ['I', 'II', 'III']}, {'name': 'Diet (organic or conventional)', 'type': 'OTHER', 'description': 'organic or conventional diet', 'armGroupLabels': ['I', 'II', 'III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1984', 'city': 'Frederiksberg', 'country': 'Denmark', 'facility': 'IHE-LIFE', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Arne Astrup', 'investigatorAffiliation': 'University of Copenhagen'}}}}