Polyphenols in Sorghum and Iron Absorption

Study Overview
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Brief Summary
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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.

Official Title
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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?

Conditions
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Iron Absorption in Presence of Polyphenols

Intervention / Treatment
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* Dietary Supplement: labeled iron solutions


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Iron absorption<br> | Dietary Supplement: labeled iron solutions<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iron absorption, polyphenols, sodium iron EDTA, sorghum