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Tracking Information | |||||
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First Received Date † | August 19, 2008 | ||||
Last Updated Date | August 20, 2008 | ||||
Start Date † | October 2007 | ||||
Current Primary Outcome Measures † |
Bioavailability of trace elements and secondary metabolites [ Time Frame: 3 x 12 days ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00738166 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Health factors [ Time Frame: 3 x 12 days ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Content, Bioavailability and Health Effects of Trace Elements and Bioactive Components in Organic Agricultural Systems | ||||
Official Title † | |||||
Brief Summary | 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. |
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Detailed Description | |||||
Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Other, Double Blind (Subject, Investigator), Active Control, Crossover Assignment | ||||
Condition † | Healthy | ||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 18 | ||||
Estimated Completion Date | December 2010 | ||||
Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 45 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† |
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Location Countries † | Denmark | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00738166 | ||||
Responsible Party | Susanne Bugel PhD, IHE LIFE KU | ||||
Secondary IDs †† | M194 | ||||
Study Sponsor † | University of Copenhagen | ||||
Collaborators †† | |||||
Investigators † | |||||
Information Provided By | University of Copenhagen | ||||
Verification Date | August 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |