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A Multiple Meal Stable Iron Isotope Study in Iron Deficient Rwandese Women to Investigate the Performance of Low Phytic Acid Bean Seeds

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ClinicalTrials.gov Identifier: NCT02215278
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : August 16, 2018
Sponsor:
Collaborator:
HarvestPlus
Information provided by (Responsible Party):
Nicolai Petry, GroundWork

Brief Summary:
Recent iron absorption studies with biofortified beans indicated that the currently developed beans do not provide an extra amount of iron compared to normal iron beans. This effect was ascribed to the inhibitory nature of phytic acid (PA), which is present in high concentrations. A possible solution to alleviate problems associated with the high PA concentration in beans might be low phytic acid (lpa) bean seeds. These beans, which exhibit a good agronomic performance, were tested in a human absorption study in Switzerland and provided a higher amount of bioavailable iron compared to their parent beans with normal PA concentrations. However, the informative value of the study for the real life situation is limited due to the simple study design with a relatively large amount of isotopic label added extrinsically (≈30% of total iron). Furthermore, the study was conducted in iron sufficient women in a non-bean consuming population. Additional investigations are necessary to verify that iron bioavailability from lpa beans is high and that their performance is better compared to common biofortified beans in a real life situation. A multiple meal randomized crossover study in Rwandese women with low iron status will be done to measure iron absorption from three different beans (lpa bean line, biofortified high iron bean, normal iron bean as a control). During the study, the subjects will receive multiple meals to reduce the amount of extrinsic label, therefore more closely simulating hypothetical dietary iron intake from lpa beans. This will also allow to avoid an overestimation of the effect of inhibitors and to minimize the influence of intra subject day to day variation. The study will be divided into two parts. In part one, two of the three bean varieties will be fed as part of composite meals over several days (morning and lunch) and in part two, the remaining bean will be administered as part of composite meals over several days (morning and lunch). Iron absorption from the three varieties will be measured and compared with erythrocyte incorporation of stable isotopic labels 14 days after test meal administration.

Condition or disease Intervention/treatment Phase
Enrichment of Blood With Stable Iron Isotopes Dietary Supplement: 10 x 55 g/ bean per arm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Study Start Date : February 2014
Actual Primary Completion Date : April 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: low phytic acid bean (lpa variety) Dietary Supplement: 10 x 55 g/ bean per arm
Experimental: high iron biofortified bean variety Dietary Supplement: 10 x 55 g/ bean per arm
Experimental: normal iron, normal phytic acid bean Dietary Supplement: 10 x 55 g/ bean per arm



Primary Outcome Measures :
  1. Iron bioavailability from lpa bean variety compared to an iron biofortified variety [ Time Frame: 2 month ]

    Iron bioavailability is determined by measuring the amounts of isotopic labels in blood 14 d after administration of the test meals. It is calculated on the basis of the shift in iron isotope ratios and on the estimated amount of iron circulating in the body. Circulating iron is calculated based on the blood volume estimated from height and weight and measured Hb concentration. The calculations are based on the principles of isotope dilution. For calculation of fractional absorption, 80% incorporation of the absorbed Fe into red blood cells is assumed.

    Isotopic analysis are performed by negative thermal ionization mass spectrometry using a magnetic sector field mass spectrometer equipped with a multi-collector system for simultaneous ion beam detection




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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • non pregnant women, non lactating women
  • 18-30 years
  • <65 kg

Exclusion Criteria:

  • metabolic, chronic or gastrointestinal disease
  • long term medication
  • blood donation within the last 6 month

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215278


Locations
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Rwanda
University of Rwanda
Butare, Huye, Rwanda
Sponsors and Collaborators
GroundWork
HarvestPlus
Investigators
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Principal Investigator: Nicolai Petry, PhD GroundWork
Principal Investigator: Diego Moretti, PhD ETH Zurich

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nicolai Petry, Dr. of Science ETH, GroundWork
ClinicalTrials.gov Identifier: NCT02215278    
Other Study ID Numbers: lpa_002
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Keywords provided by Nicolai Petry, GroundWork:
iron biofortification
lpa bean
stable iron isotope study
phytic acid
Additional relevant MeSH terms:
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Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs