Impact of Bean Polyphenols and Phytic Acid on Iron Absorption
| Tracking Information | |||||
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| First Received Date ICMJE | November 9, 2011 | ||||
| Last Updated Date | June 18, 2012 | ||||
| Start Date ICMJE | December 2011 | ||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Shift in iron isotopic composition in blood after consumption of different bean varieties [ Time Frame: 1 month ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Shift in iron isotopic composition in blood after consumption of different bean varieties [ Time Frame: 6 month ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01472484 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Impact of Bean Polyphenols and Phytic Acid on Iron Absorption | ||||
| Official Title ICMJE | A Stable Iron Isotope Study to Investigate the Impact of Phytic Acid and Polyphenols on Iron Absorption From Beans in Humans | ||||
| Brief Summary | Recently isolated low PA varieties (lpa) in wheat, rice, maize, barley and beans might have the potential to alleviate iron bioavailability problems associated with PA. These plants have normal phosphate levels, but reduced PA phosphate due to various modifications of the biosynthetic pathway of PA. So far lpa crops are in an early stage of development, most of them exhibiting reduced yield and seed germination. However, the lpa bean isolated by Campion and co-workers 2009 by chemical mutagenesis exhibited only 10 % of the native bean PA concentration without any defects in terms of growth and yield. Crossing the lpa variety with bean varieties low in PP and high in iron might lead to the development of a variety which has the potential to improve the iron status of bean consuming populations. The following study will evaluate the relative impact of PA and PP on iron absorption from beans by comparing iron absorption from four different bean varieties. Iron absorption from a bean with normal PA concentration and high PP concentration will be compared to iron absorption from a bean with normal PA and low PP concentration as well as to two lpa varieties, one with high and one with low PP concentration. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
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| Condition ICMJE | Blood Iron Isotope Enrichment | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | January 2012 | ||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 40 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Switzerland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01472484 | ||||
| Other Study ID Numbers ICMJE | lpa_586/8X87 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology | ||||
| Study Sponsor ICMJE | Swiss Federal Institute of Technology | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Swiss Federal Institute of Technology | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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