Enrichment of Blood With Stable Iron IsotopesNCT02215278
A Multiple Meal Stable Iron Isotope Study in Iron Deficient Rwandese Women to Investigate the Performance of Low Phytic Acid Bean Seeds
A study testing 10 x 55 g/ bean per arm in people with Enrichment of Blood With Stable Iron Isotopes, run by GroundWork at 1 site in Rwanda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Enrichment of Blood With Stable Iron Isotopes
- What is being tested?
- 10 x 55 g/ bean per arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteRwanda
- Study dates
- Feb 2014to May 2014
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- non pregnant women, non lactating women
- 18-30 years
- <65 kg
Who cannot join
- metabolic, chronic or gastrointestinal disease
- long term medication
- blood donation within the last 6 month
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- 10 x 55 g/ bean per arm
- Keywords
- iron biofortification, lpa bean, stable iron isotope study, phytic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 x 55 g/ bean per armDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| low phytic acid bean (lpa variety) | Experimental | Not described Receives: Dietary Supplement: 10 x 55 g/ bean per arm |
| high iron biofortified bean variety | Experimental | Not described Receives: Dietary Supplement: 10 x 55 g/ bean per arm |
| normal iron, normal phytic acid bean | Experimental | Not described Receives: Dietary Supplement: 10 x 55 g/ bean per arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2014
- Study completionMay 2014
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 Blood With Stable Iron IsotopesStudies 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
- GroundWork
- Sponsor type
- University, hospital or other
- Collaborators
- HarvestPlus
- Responsible party
- Principal investigator, Nicolai Petry, GroundWork
- Investigators
- Nicolai Petry, PhD, Principal investigator, GroundWorkDiego Moretti, PhD, Principal investigator, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215278
- Sponsor's protocol ID
- lpa_002
- Status last verified
- Aug 2018
- First submitted
- 12 Jun 2014
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27029940
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Meal Stable Iron Isotope Study in Iron Deficient Rwandese Women to Investigate the Performance of Low Phytic Acid Bean Seeds
- ClinicalTrials.gov ID
- NCT02215278
- Acronym / sponsor ID
- lpa_002
- Keywords
- iron biofortification, lpa bean, stable iron isotope study, phytic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- GroundWorkUniversity, hospital or other
- Collaborators
- HarvestPlus
- Study start
- Feb 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Aug 2014 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- non pregnant women, non lactating women
- 18-30 years
- <65 kg
Key exclusion criteria (3 listed)
- metabolic, chronic or gastrointestinal disease
- long term medication
- blood donation within the last 6 month
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 |
|---|---|---|
| 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 |
Primary outcome
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
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 16 Aug 2018.
- Derived from this study: PubMed 27029940Petry 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.
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.
Nicolai Petry, PhD principal investigator
GroundWork
Diego Moretti, PhD principal investigator
ETH Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 x 55 g/ bean per arm in people with Enrichment of Blood With Stable Iron Isotopes, run by GroundWork 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 16 Aug 2018. 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?
Iron bioavailability from lpa bean variety compared to an iron biofortified variety (time frame: 2 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 NCT02215278, 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 16 Aug 2018.