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CompletedNCT01162616Updated Jul 4, 2012

Polyphenols in Sorghum and Iron Absorption

An Early Phase 1 interventional study of labeled iron solutions in Iron Absorption in Presence of Polyphenols, sponsored by Swiss Federal Institute of Technology. Completed at 1 site in Switzerland. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-04.

Sponsored by Swiss Federal Institute of Technology · Early Phase 1, Interventional, and Basic science

Phase
Early Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Iron Absorption in Presence of Polyphenols

Keywords

  • iron absorption
  • polyphenols
  • sodium iron EDTA
  • sorghum
03

In context

Lead sponsor

Swiss Federal Institute of Technology is the lead sponsor of 152 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
50 participants (actual)

Study arms

  • Other
    Iron absorption

    Dietary Supplement: labeled iron solutions

Interventions

  • Dietary supplementlabeled iron solutions

    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)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Study day 17 (16 days after administration of isotopic label in the first test meal/End of the study)

07

Study locations

1 site
  • Swiss Federal Institute of Technology ETH Zurich
    Zurich, 8092, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01162616
Lead sponsor
Swiss Federal Institute of Technology
Responsible party
Prof. Michael B. Zimmermann (Msc, Swiss Federal Institute of Technology) — Principal investigator
First posted
Jul 14, 2010
Start date
Aug 2010
Primary completion
Mar 2012
Completion
Apr 2012
Last update
Jul 4, 2012

Study contacts

Richard Hurrell, Prof.
principal investigator · Swiss Federal Institute of Technology (ETH Zürich)
View the source record on ClinicalTrials.gov ↗

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