Enrichment of BloodNCT01521273
Iron Absorption From Biofortified Beans With Different Levels of Phytic Acid
A study testing Bean varieties in people with Enrichment of Blood, run by Swiss Federal Institute of Technology at 1 site in Rwanda.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Enrichment of Blood
- What is being tested?
- Bean varieties
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteRwanda
- Study dates
- Mar 2012to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-pregnant, non-lactating women
- Between 18 and 40 years
- Below 65kg
Who cannot join
- Metabolic, chronic and gastro-intestinal disease
- Long-term medication
- Blood donation within 6 month before the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Enrichment of Blood
- Being tested
- Bean varieties
- Keywords
- beans, biofortification, phytic acid, iron, iron isotopes, different phytic acid concentrations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bean varietiesOther
10 x 50 g/ arm
| Study group | Role | What they receive |
|---|---|---|
| high iron bean with native phytic acid concentration | Experimental | Not described Receives: Other: Bean varieties |
| normal iron bean with native phytic acid concentration | Experimental | Not described Receives: Other: Bean varieties |
| high iron bean partially dephytinized | Experimental | Not described Receives: Other: Bean varieties |
| normal iron bean partially dephytinized | Experimental | Not described Receives: Other: Bean varieties |
| high iron bean totally dephytinized | Experimental | Not described Receives: Other: Bean varieties |
| normal iron bean totally dephytinized | Experimental | Not described Receives: Other: Bean varieties |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of different bean phytic acid concentrations on iron absorption measured by stable iron isotope techniques
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enrichment of BloodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
- Investigators
- Richard Hurrell, Prof. Dr., Study director, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521273
- Sponsor's protocol ID
- Rwa3
- Status last verified
- Nov 2012
- First submitted
- 25 Jan 2012
- Last updated
- 8 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Petry N, Egli I, Gahutu JB, Tugirimana PL, Boy E, Hurrell R. Phytic acid concentration influences iron bioavailability from biofortified beans in Rwandese women with low iron status. J Nutr. 2014 Nov;144(11):1681-7. doi: 10.3945/jn.114.192989. Epub 2014 Sep 3.
PubMed 25332466
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Meal Study to Evaluate the Role of Phytic Acid From Beans on Human Iron Absorption
- ClinicalTrials.gov ID
- NCT01521273
- Acronym / sponsor ID
- Rwa3
- Conditions
- Enrichment of Blood
- Keywords
- beans, biofortification, phytic acid, iron, iron isotopes, different phytic acid concentrations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| high iron bean with native phytic acid concentration | Experimental | Other: Bean varieties |
| normal iron bean with native phytic acid concentration | Experimental | Other: Bean varieties |
| high iron bean partially dephytinized | Experimental | Other: Bean varieties |
| normal iron bean partially dephytinized | Experimental | Other: Bean varieties |
| high iron bean totally dephytinized | Experimental | Other: Bean varieties |
| normal iron bean totally dephytinized | Experimental | Other: Bean varieties |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Non-pregnant, non-lactating women
- Between 18 and 40 years
- Below 65kg
Key exclusion criteria (3 listed)
- Metabolic, chronic and gastro-intestinal disease
- Long-term medication
- Blood donation within 6 month before the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bean varieties10 x 50 g/ arm | Other | high iron bean partially dephytinized, high iron bean totally dephytinized, high iron bean with native phytic acid concentration, normal iron bean partially dephytinized, normal iron bean totally dephytinized, normal iron bean with native phytic acid concentration |
Primary outcome
The impact of different bean phytic acid concentrations on iron absorption measured by stable iron isotope techniques
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2012.
- Derived from this study: PubMed 25332466Petry N, Egli I, Gahutu JB, Tugirimana PL, Boy E, Hurrell R. Phytic acid concentration influences iron bioavailability from biofortified beans in Rwandese women with low iron status. J Nutr. 2014 Nov;144(11):1681-7. doi: 10.3945/jn.114.192989. Epub 2014 Sep 3.
Related trials for Enrichment of Blood
RecruitingPhase 1
Enrichment of Glutathione Using Gamma-glutamylcysteine Supplementation in Parkinson's Disease Patients.
Parkinsons Disease (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Hurrell, Prof. Dr. study director
Swiss Federal Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bean varieties in people with Enrichment of Blood, run by Swiss Federal Institute of Technology at 1 site in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The impact of different bean phytic acid concentrations on iron absorption measured by stable iron isotope techniques (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01521273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2012.