Nutrition Study of Effect of High Iron Beans on Iron Status

• ClinicalTrials.gov Identifier: NCT01594359
• Recruitment Status: Completed
• First Posted: May 9, 2012
• Last Update Posted: December 2, 2015
• Sponsor: Swiss Federal Institute of Technology
• Collaborator: HarvestPlus
• Information provided by (Responsible Party): Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

Tracking Information

• First Submitted Date: May 3, 2012
• First Posted Date: May 9, 2012
• Last Update Posted Date: December 2, 2015
• Study Start Date: August 2012
• Actual Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 7, 2012)

Improved iron status [ Time Frame: 1 year ]

Improvement in serum ferritin

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 7, 2012)

Improved physical and cognitive performance [ Time Frame: 1 year ]

Tests on physical performance using accelerometers and breath tests; cognitive tests

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Nutrition Study of Effect of High Iron Beans on Iron Status
• Official Title: Efficacy of Iron Biofortified Beans in Improving the Iron Status of Rwandan Adolescent Girls: A Randomized Control Trial
• Brief Summary: 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: The goal of the study is to determine the efficacy of biofortified beans in improving the iron status of young women in Rwanda.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Basic Science
• Condition: Iron Deficiency

Intervention

• Other: 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
• Other: BEAN
  Placebo

Study Arms

• Active Comparator: High iron bean
  High-iron bean
  Intervention: Other: Biofortified beans
• Placebo Comparator: Low iron bean
  Low-iron bean
  Intervention: Other: BEAN

Publications *

• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 7, 2012): 300
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 2014
• Actual Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Rwanda

Administrative Information

• NCT Number: NCT01594359
• Other Study ID Numbers: Project #8209
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
• Study Sponsor: Swiss Federal Institute of Technology
• Collaborators: HarvestPlus

Investigators

• Principal Investigator: Richard F. Hurrell, PhD; ETH Zurich

• PRS Account: Swiss Federal Institute of Technology
• Verification Date: November 2015