Iron Absorption in Presence of Polyphenols Clinical Trial
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?
| Verified date | July 2012 |
| Source | Swiss Federal Institute of Technology |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Ethikkommission |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | April 2012 |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 40 Years |
| Eligibility |
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: - 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) |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Swiss Federal Institute of Technology ETH Zurich | Zurich |
| Lead Sponsor | Collaborator |
|---|---|
| Swiss Federal Institute of Technology |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
Study day 17 (16 days after administration of isotopic label in the first test meal/End of the study) | No |