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Nutrition Study of Effect of High Iron Beans on Iron Status

NCT ID: NCT01594359

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-08-31

Brief Summary

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The purpose of this study is to determine whether beans bred to have a high iron content are effective in improving the iron status of young women.

Detailed Description

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The goal of the study is to determine the efficacy of biofortified beans in improving the iron status of young women in Rwanda.

Conditions

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Iron Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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High iron bean

High-iron bean

Group Type ACTIVE_COMPARATOR

Biofortified beans

Intervention Type OTHER

Comparison of two types of the common bean that are similar in all aspects except their iron concentration - one has a high iron concentration while the other has low iron concentration

Low iron bean

Low-iron bean

Group Type PLACEBO_COMPARATOR

BEAN

Intervention Type OTHER

Placebo

Interventions

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Biofortified beans

Comparison of two types of the common bean that are similar in all aspects except their iron concentration - one has a high iron concentration while the other has low iron concentration

Intervention Type OTHER

BEAN

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Non-pregnant adolescent subjects of reproductive age with low iron stores with or without mild anemia, who are otherwise healthy, will be enrolled in the study

Exclusion Criteria

* Pregnant, lactating, severe anemia, low BMI would be excluded
Minimum Eligible Age

12 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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HarvestPlus

OTHER

Sponsor Role collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Prof. Michael B. Zimmermann

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard F. Hurrell, PhD

Role: PRINCIPAL_INVESTIGATOR

ETH Zurich

Locations

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National University of Rwanda

Butare, Kigali, Rwanda

Site Status

Kigali, Kigali, Rwanda

Site Status

Countries

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Rwanda

References

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Luna SV, Pompano LM, Lung'aho M, Gahutu JB, Haas JD. Increased Iron Status during a Feeding Trial of Iron-Biofortified Beans Increases Physical Work Efficiency in Rwandan Women. J Nutr. 2020 May 1;150(5):1093-1099. doi: 10.1093/jn/nxaa016.

Reference Type DERIVED
PMID: 32006009 (View on PubMed)

Wenger MJ, Rhoten SE, Murray-Kolb LE, Scott SP, Boy E, Gahutu JB, Haas JD. Changes in Iron Status Are Related to Changes in Brain Activity and Behavior in Rwandan Female University Students: Results from a Randomized Controlled Efficacy Trial Involving Iron-Biofortified Beans. J Nutr. 2019 Apr 1;149(4):687-697. doi: 10.1093/jn/nxy265.

Reference Type DERIVED
PMID: 30926992 (View on PubMed)

Murray-Kolb LE, Wenger MJ, Scott SP, Rhoten SE, Lung'aho MG, Haas JD. Consumption of Iron-Biofortified Beans Positively Affects Cognitive Performance in 18- to 27-Year-Old Rwandan Female College Students in an 18-Week Randomized Controlled Efficacy Trial. J Nutr. 2017 Nov;147(11):2109-2117. doi: 10.3945/jn.117.255356. Epub 2017 Sep 27.

Reference Type DERIVED
PMID: 28954841 (View on PubMed)

Haas JD, Luna SV, Lung'aho MG, Wenger MJ, Murray-Kolb LE, Beebe S, Gahutu JB, Egli IM. Consuming Iron Biofortified Beans Increases Iron Status in Rwandan Women after 128 Days in a Randomized Controlled Feeding Trial. J Nutr. 2016 Aug;146(8):1586-92. doi: 10.3945/jn.115.224741. Epub 2016 Jun 29.

Reference Type DERIVED
PMID: 27358417 (View on PubMed)

Other Identifiers

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Project #8209

Identifier Type: -

Identifier Source: org_study_id