Iron Absorption From Biofortified Beans With Different Levels of Phytic Acid

November 7, 2012 updated by: Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Rwanda
      • Butare, Rwanda
        • National University of Rwanda (NUR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The impact of different bean phytic acid concentrations on iron absorption measured by stable iron isotope techniques
Time Frame: 3 month
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Federal Institute of Technology

Investigators

  • Study Director: Richard Hurrell, Prof. Dr., Swiss Federal Institute of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 25, 2012

First Submitted That Met QC Criteria

January 27, 2012

First Posted (Estimate)

January 30, 2012

Study Record Updates

Last Update Posted (Estimate)

November 8, 2012

Last Update Submitted That Met QC Criteria

November 7, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Rwa3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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