Iron Absorption in Presence of PolyphenolsEarly Phase 1NCT01162616
Polyphenols in Sorghum and Iron Absorption
A Early Phase 1 study testing labeled iron solutions in people with Iron Absorption in Presence of Polyphenols, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
Iron deficiency and iron deficiency anemia are two major public health problems in developing countries. In these countries, the use of monotonous plant-based diets, low in animal source food but high in iron absorption inhibitors such as phytic acid or polyphenol, lead to poor iron status or aggravate poor iron… 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
- Iron Absorption in Presence of Polyphenols
- What is being tested?
- labeled iron solutions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2010to Apr 2012
- Phase
- Early Phase 1
- 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
- Females of reproductive age, 18-40 years
- Maximum body weight 65 kg
- Normal body mass index (18.5-25 kg/m2)
- No intake of mineral/vitamin supplements 2 weeks before and during the study
- No metabolic or gastrointestinal disorders
Who cannot join
- Pregnancy or lactation
- Regular intake of medication (except oral contraceptives)
- Blood donation or significant blood loss (accident, surgery) over the past 4 months
- Currently participating in another clinical trial or having participated in another clinical trial during the last 3 months prior to the beginning of this study
- Former participation in a study involving administration of iron stable isotopes
- Subject who cannot be expected to comply with study protocol
- Eating disorders or food allergy
- High C-reactive protein levels (>5 mg/L)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Federal Institute of Technology ETH Zurich
Zurich, Canton of Zurich, 8092
About this study
Official title: Is There a Dose-dependant Effect of Sorghum Polyphenols on Human Iron Absorption and Can it be Overcome by Sodium Iron EDTA or by Adding Vitamin C or Laccase?
Iron deficiency and iron deficiency anemia are two major public health problems in developing countries. In these countries, the use of monotonous plant-based diets, low in animal source food but high in iron absorption inhibitors such as phytic acid or polyphenol, lead to poor iron status or aggravate poor iron status caused by infections. In many West African countries sorghum is a major source of energy, protein, vitamins and minerals especially for the most poverty-stricken people. Some sorghum varieties are known to contain high levels of polyphenols which have an inhibitory effect on iron absorption in humans. Polyphenols are a huge group of plant metabolites with varying chemical structures. Depending on their structure, the level of complex formation with iron in the intestine and thus the negative effect on iron absorption is different.
Micronutrient deficiency can be combated by fortification of plant-based staples. Fortification is a promising food-based approach which can be applied when other strategies fail to provide adequate levels of the respective micronutrient in the diet. To fortify foods with iron, a wide variety of different iron compounds have been used. The iron compound sodium iron ethylenediaminetetraacetic (NaFeEDTA) overcomes the inhibitory effect of phytate on human iron absorption. No information about the potential enhancing effect of NaFeEDTA in presence of polyphenol is available.
The aims of the study are to investigate the effect of different sorghum polyphenol concentrations on human iron absorption and to investigate if the negative impact of the polyphenols can be overcome by using NaFeEDTA as iron compound. The study will include 32 apparently healthy young women which will consume sorghum porridges with different polyphenol levels and sorghum porridges fortified with ferrous sulfate as compared to NaFeEDTA. Furthermore test meals with added vitamin C or added laccase will be compared to a control meal. Iron absorption will be determined by stable isotope technique.
- Being tested
- labeled iron solutions
- Keywords
- iron absorption, polyphenols, sodium iron EDTA, sorghum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
labeled iron solutionsDietary supplement
labeled iron as 2 mg 58FeSO4, 57FeSO4 or 54FeSO4 per test portion (50g sorghum) 2 mg labeled iron as NaFeEDTA per test portion (50g sorghum)
| Study group | Role | What they receive |
|---|---|---|
| Iron absorption | Other | Not described Receives: Dietary Supplement: labeled iron solutions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron isotope ratio in blood samples
Whole blood samples will be collected to measure the shift in iron isotope ratios 16 days after administration of isotopic label in the first test meal.
First test meal on study day 1, Second test meal on study day 2, Third (last) test meal on study day 3, Measurement of iron isotopic shift in blood samples collected on study day 17
Measured: Study day 17 (16 days after administration of isotopic label in the first test meal/End of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Absorption in Presence of PolyphenolsStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 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., Principal investigator, Swiss Federal Institute of Technology (ETH Zürich)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162616
- Sponsor's protocol ID
- PP_Fe_Study Sorghum
- Status last verified
- Jul 2012
- First submitted
- 13 Jul 2010
- Last updated
- 4 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Dose-dependant Effect of Sorghum Polyphenols on Human Iron Absorption and Can it be Overcome by Sodium Iron EDTA or by Adding Vitamin C or Laccase?
- ClinicalTrials.gov ID
- NCT01162616
- Acronym / sponsor ID
- PP_Fe_Study Sorghum
- Keywords
- iron absorption, polyphenols, sodium iron EDTA, sorghum
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 14 Jul 2010 (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 two major public health problems in developing countries. In these countries, the use of monotonous plant-based diets, low in animal source food but high in iron absorption inhibitors such as phytic acid or polyphenol, lead to poor iron status or aggravate poor iron status caused by infections. In many West African countries sorghum is a major source of energy, protein, vitamins and minerals especially for the most poverty-stricken people. Some sorghum varieties are known to contain high levels of polyphenols which have an inhibitory effect on iron absorption in humans. Polyphenols are a huge group of plant metabolites with varying chemical structures. Depending on their structure, the level of complex formation with iron in the intestine and thus the negative effect on iron absorption is different.
Micronutrient deficiency can be combated by fortification of plant-based staples. Fortification is a promising food-based approach which can be applied when other strategies fail to provide adequate levels of the respective micronutrient in the diet. To fortify foods with iron, a wide variety of different iron compounds have been used. The iron compound sodium iron ethylenediaminetetraacetic (NaFeEDTA) overcomes the inhibitory effect of phytate on human iron absorption. No information about the potential enhancing effect of NaFeEDTA in presence of polyphenol is available.
The aims of the study are to investigate the effect of different sorghum polyphenol concentrations on human iron absorption and to investigate if the negative impact of the polyphenols can be overcome by using NaFeEDTA as iron compound. The study will include 32 apparently healthy young women which will consume sorghum porridges with different polyphenol levels and sorghum porridges fortified with ferrous sulfate as compared to NaFeEDTA. Furthermore test meals with added vitamin C or added laccase will be compared to a control meal. Iron absorption will be determined by stable isotope technique.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iron absorption | Other | Dietary Supplement: labeled iron solutions |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Females of reproductive age, 18-40 years
- Maximum body weight 65 kg
- Normal body mass index (18.5-25 kg/m2)
- No intake of mineral/vitamin supplements 2 weeks before and during the study
- No metabolic or gastrointestinal disorders
Key exclusion criteria (8 listed)
- Pregnancy or lactation
- Regular intake of medication (except oral contraceptives)
- Blood donation or significant blood loss (accident, surgery) over the past 4 months
- Currently participating in another clinical trial or having participated in another clinical trial during the last 3 months prior to the beginning of this study
- Former participation in a study involving administration of iron stable isotopes
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 |
|---|---|---|
| labeled iron solutionslabeled iron as 2 mg 58FeSO4, 57FeSO4 or 54FeSO4 per test portion (50g sorghum) 2 mg labeled iron as NaFeEDTA per test portion (50g sorghum) | Dietary supplement | Iron absorption |
Primary outcome
Iron isotope ratio in blood samples
Time frame: Study day 17 (16 days after administration of isotopic label in the first test meal/End of the study)
Whole blood samples will be collected to measure the shift in iron isotope ratios 16 days after administration of isotopic label in the first test meal. First test meal on study day 1, Second test meal on study day 2, Third (last) test meal on study day 3, Measurement of iron isotopic shift in blood samples collected on study day 17
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 4 Jul 2012.
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. principal investigator
Swiss Federal Institute of Technology (ETH Zürich)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing labeled iron solutions in people with Iron Absorption in Presence of Polyphenols, 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 5 inclusion and 8 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 4 Jul 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 isotope ratio in blood samples (time frame: Study day 17 (16 days after administration of isotopic label in the first test meal/End of the study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jul 2012; AzTrials last refreshed its copy on 30 Oct 2026.