Blood Iron Isotope EnrichmentNCT01472484
Impact of Bean Polyphenols and Phytic Acid on Iron Absorption
A study testing 586/8x87 white, 586/8x87 brown and BAT 881 in people with Blood Iron Isotope Enrichment, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
Recently isolated low PA varieties (lpa) in wheat, rice, maize, barley and beans might have the potential to alleviate iron bioavailability problems associated with PA. These plants have normal phosphate levels, but reduced PA phosphate due to various modifications of the biosynthetic pathway of PA. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Iron Isotope Enrichment
- What is being tested?
- 586/8x87 white, 586/8x87 brown and BAT 881
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2011to Jan 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 40 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 Stable Iron Isotope Study to Investigate the Impact of Phytic Acid and Polyphenols on Iron Absorption From Beans in Humans
Recently isolated low PA varieties (lpa) in wheat, rice, maize, barley and beans might have the potential to alleviate iron bioavailability problems associated with PA. These plants have normal phosphate levels, but reduced PA phosphate due to various modifications of the biosynthetic pathway of PA. So far lpa crops are in an early stage of development, most of them exhibiting reduced yield and seed germination. However, the lpa bean isolated by Campion and co-workers 2009 by chemical mutagenesis exhibited only 10 % of the native bean PA concentration without any defects in terms of growth and yield.
Crossing the lpa variety with bean varieties low in PP and high in iron might lead to the development of a variety which has the potential to improve the iron status of bean consuming populations.
The following study will evaluate the relative impact of PA and PP on iron absorption from beans by comparing iron absorption from four different bean varieties. Iron absorption from a bean with normal PA concentration and high PP concentration will be compared to iron absorption from a bean with normal PA and low PP concentration as well as to two lpa varieties, one with high and one with low PP concentration.
- Conditions
- Blood Iron Isotope Enrichment
- Being tested
- 586/8x87 white, 586/8x87 brown, BAT 881, 586/8
- Keywords
- beans, lpa mutant, polyphenols, phytic acid, stable iron isotopes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
586/8x87 whiteOther
2 x 50 g
586/8x87 brownOther
2 x 50 g
BAT 881Other
2 x 50 g
586/8Other
2 x 50 g
| Study group | Role | What they receive |
|---|---|---|
| lpa with high polyphenol | Experimental | Not described Receives: Other: 586/8x87 brown |
| lpa with low polyphenol | Experimental | Not described Receives: Other: 586/8x87 white |
| control bean with low polyphenol | Experimental | Not described Receives: Other: 586/8 |
| control bean with high polyphenol | Experimental | Not described Receives: Other: BAT 881 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shift in iron isotopic composition in blood after consumption of different bean varieties
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionJan 2012
- Study completionJan 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 Blood Iron Isotope EnrichmentStudies 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
- 20 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., Principal investigator, ETH Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472484
- Sponsor's protocol ID
- lpa_586/8X87
- Status last verified
- Jun 2012
- First submitted
- 9 Nov 2011
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Petry N, Egli I, Campion B, Nielsen E, Hurrell R. Genetic reduction of phytate in common bean (Phaseolus vulgaris L.) seeds increases iron absorption in young women. J Nutr. 2013 Aug;143(8):1219-24. doi: 10.3945/jn.113.175067. Epub 2013 Jun 19.
PubMed 23784069
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stable Iron Isotope Study to Investigate the Impact of Phytic Acid and Polyphenols on Iron Absorption From Beans in Humans
- ClinicalTrials.gov ID
- NCT01472484
- Acronym / sponsor ID
- lpa_586/8X87
- Conditions
- Blood Iron Isotope Enrichment
- Keywords
- beans, lpa mutant, polyphenols, phytic acid, stable iron isotopes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 16 Nov 2011 (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.
Recently isolated low PA varieties (lpa) in wheat, rice, maize, barley and beans might have the potential to alleviate iron bioavailability problems associated with PA. These plants have normal phosphate levels, but reduced PA phosphate due to various modifications of the biosynthetic pathway of PA. So far lpa crops are in an early stage of development, most of them exhibiting reduced yield and seed germination. However, the lpa bean isolated by Campion and co-workers 2009 by chemical mutagenesis exhibited only 10 % of the native bean PA concentration without any defects in terms of growth and yield.
Crossing the lpa variety with bean varieties low in PP and high in iron might lead to the development of a variety which has the potential to improve the iron status of bean consuming populations.
The following study will evaluate the relative impact of PA and PP on iron absorption from beans by comparing iron absorption from four different bean varieties. Iron absorption from a bean with normal PA concentration and high PP concentration will be compared to iron absorption from a bean with normal PA and low PP concentration as well as to two lpa varieties, one with high and one with low PP concentration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| lpa with high polyphenol | Experimental | Other: 586/8x87 brown |
| lpa with low polyphenol | Experimental | Other: 586/8x87 white |
| control bean with low polyphenol | Experimental | Other: 586/8 |
| control bean with high polyphenol | Experimental | Other: BAT 881 |
Who may qualify
- Ages
- 18 to 40 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 |
|---|---|---|
| 586/8x87 white2 x 50 g | Other | lpa with low polyphenol |
| 586/8x87 brown2 x 50 g | Other | lpa with high polyphenol |
| BAT 8812 x 50 g | Other | control bean with high polyphenol |
| 586/82 x 50 g | Other | control bean with low polyphenol |
Primary outcome
Shift in iron isotopic composition in blood after consumption of different bean varieties
Time frame: 1 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 19 Jun 2012.
- Derived from this study: PubMed 23784069Petry N, Egli I, Campion B, Nielsen E, Hurrell R. Genetic reduction of phytate in common bean (Phaseolus vulgaris L.) seeds increases iron absorption in young women. J Nutr. 2013 Aug;143(8):1219-24. doi: 10.3945/jn.113.175067. Epub 2013 Jun 19.
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. principal investigator
ETH Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 586/8x87 white, 586/8x87 brown and BAT 881 in people with Blood Iron Isotope Enrichment, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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 19 Jun 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 Switzerland. 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?
Shift in iron isotopic composition in blood after consumption of different bean varieties (time frame: 1 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 NCT01472484, 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 19 Jun 2012.