A Multiple Meal Stable Iron Isotope Study in Iron Deficie... | NCT02215278

NCT02215278

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
HarvestPlus	OTHER

Oversight Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
10 x 55 g/ bean per arm	Dietary Supplement		high iron biofortified bean variety low phytic acid bean (lpa variety) normal iron, normal phytic acid bean

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Iron bioavailability from lpa bean variety compared to an iron biofortified variety	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	2 month

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Nicolai Petry, PhD	GroundWork	Principal Investigator
Diego Moretti, PhD	ETH Zurich	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Rwanda		Butare	Huye		Rwanda

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27029940	Derived	Petry N, Rohner F, Gahutu JB, Campion B, Boy E, Tugirimana PL, Zimmerman MB, Zwahlen C, Wirth JP, Moretti D. In Rwandese Women with Low Iron Status, Iron Absorption from Low-Phytic Acid Beans and Biofortified Beans Is Comparable, but Low-Phytic Acid Beans Cause Adverse Gastrointestinal Symptoms. J Nutr. 2016 May;146(5):970-5. doi: 10.3945/jn.115.223693. Epub 2016 Mar 30.