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
  Purpose

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.


Condition Intervention
Enrichment of Blood
Other: Bean varieties

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: A Multiple Meal Study to Evaluate the Role of Phytic Acid From Beans on Human Iron Absorption

Resource links provided by NLM:


Further study details as provided by Swiss Federal Institute of Technology:

Primary Outcome Measures:
  • 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 ]

Enrollment: 25
Study Start Date: March 2012
Study Completion Date: September 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: high iron bean with native phytic acid concentration Other: Bean varieties
10 x 50 g/ arm
Experimental: normal iron bean with native phytic acid concentration Other: Bean varieties
10 x 50 g/ arm
Experimental: high iron bean partially dephytinized Other: Bean varieties
10 x 50 g/ arm
Experimental: normal iron bean partially dephytinized Other: Bean varieties
10 x 50 g/ arm
Experimental: high iron bean totally dephytinized Other: Bean varieties
10 x 50 g/ arm
Experimental: normal iron bean totally dephytinized Other: Bean varieties
10 x 50 g/ arm

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521273

Locations
Rwanda
National University of Rwanda (NUR)
Butare, Rwanda
Sponsors and Collaborators
Swiss Federal Institute of Technology
Investigators
Study Director: Richard Hurrell, Prof. Dr. Swiss Federal Institute of Technology
  More Information

No publications provided

Responsible Party: Prof. Michael B. Zimmermann, Prof. Dr. med., Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01521273     History of Changes
Other Study ID Numbers: Rwa3
Study First Received: January 25, 2012
Last Updated: November 7, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by Swiss Federal Institute of Technology:
beans
biofortification
phytic acid
iron
iron isotopes
different phytic acid concentrations

Additional relevant MeSH terms:
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014