Iron Absorption From Biofortified Beans With Different Levels of Phytic Acid

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01521273
First received: January 25, 2012
Last updated: November 7, 2012
Last verified: November 2012

January 25, 2012
November 7, 2012
March 2012
June 2012   (final data collection date for primary outcome measure)
The impact of different bean phytic acid concentrations on iron absorption measured by stable iron isotope techniques [ Time Frame: 3 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01521273 on ClinicalTrials.gov Archive Site
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Iron Absorption From Biofortified Beans With Different Levels of Phytic Acid
A Multiple Meal Study to Evaluate the Role of Phytic Acid From Beans on Human Iron Absorption

Iron deficiency and iron deficiency anemia are among the major health problems in the developing world. Women of childbearing age as well as children are the most vulnerable population groups. In Rwanda, more than 40% of the population is estimated to be anemic. A promising approach to combat iron deficiency in Rwanda is biofortification of beans. The average consumption of beans is about 150 g per person per day in Rwanda and beans are a major staple food. Traditional plant breeding has increased the iron content of certain bean varieties from about 5 to 11 mg/100g. Iron absorption from beans however is with about 2-3% low because of high phytate and high polyphenol contents. A recently conducted study in Rwanda showed that the total amount of iron absorbed from a biofortified high iron bean was similar to the amount of iron absorbed from a control bean, which had a 50% lower iron concentration. This was surprising since the subjects had a low iron status and where therefore expected to maximize iron absorption. However, it was concluded that the additional iron bred into the bean was not bioavailable most likely due to the strong inhibitory nature of phytate in the high iron bean. To clarify that, a multiple meal study (iron absorption study) in collaboration of the Human Nutrition Laboratory of ETH Zurich and the Medical Faculty of the National University of Rwanda is planned. Subjects will receive two different bean varieties (normal iron vs. high iron) in combination with other food ingredients typical for that region. The bean varieties will be served with native phytate concentration, partially dephytinized (50%) or totally dephytinized.

Subjects will be apparently healthy females of reproductive age (18-30y). Iron absorption will be determined by stable isotope techniques.

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Interventional
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Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Enrichment of Blood
Other: Bean varieties
10 x 50 g/ arm
  • Experimental: high iron bean with native phytic acid concentration
    Intervention: Other: Bean varieties
  • Experimental: normal iron bean with native phytic acid concentration
    Intervention: Other: Bean varieties
  • Experimental: high iron bean partially dephytinized
    Intervention: Other: Bean varieties
  • Experimental: normal iron bean partially dephytinized
    Intervention: Other: Bean varieties
  • Experimental: high iron bean totally dephytinized
    Intervention: Other: Bean varieties
  • Experimental: normal iron bean totally dephytinized
    Intervention: Other: Bean varieties
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
September 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Non-pregnant, non-lactating women
  • Between 18 and 40 years
  • Below 65kg

Exclusion Criteria:

  • Metabolic, chronic and gastro-intestinal disease
  • Long-term medication
  • Blood donation within 6 month before the study
Female
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Rwanda
 
NCT01521273
Rwa3
No
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
Swiss Federal Institute of Technology
Not Provided
Study Director: Richard Hurrell, Prof. Dr. Swiss Federal Institute of Technology
Swiss Federal Institute of Technology
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP