Iron-deficiency
Conditions
Keywords
Iron deficiency, iron fortified rice, extruded rice
Brief summary
Food fortification is regarded as a safe and cost-effective approach to counteract and prevent iron deficiency. Rice is a staple food for millions of people living in regions where iron-deficiency anaemia is a significant public health problem. Therefore, rice may be a promising fortification vehicle. Ferric pyrophosphate (FePP) is an acceptable iron compound for rice fortification, due to its white colour and low reactivity with the rice matrix. However, iron from FePP generally has a low bioavailability. To increase the low iron bioavailability of FePP in fortified rice, ligands acting as solubilizing agents have been suggested, such as citric acid/trisodium citrate (CA/TSC), ethylenediaminetetraacetic acid (EDTA) and sodium pyrophosphate (NaPP). It is however unclear to which extent CA/TSC would enhance iron bioavailability in presence of phytic acid, a common inhibitor of iron absorption found in whole grains and legumes. Zinc oxide reduces iron bioavailability from FePP with and without CA/TSC, in contrast to Zinc sulphate. It is however unclear if this decrease would be also expected in presence of EDTA as solubilizing agent. Further, NaPP has been suggested as a solubilizing agent, enhancing the bioavailability from FePP in bouillon cubes. This study aim to test its effect in rice. Meals containing a high (bean sauce) and low (mixed vegetable) phytic acid level sauce will be used to simulated varying dietary backgrounds, allowing to answer the question which solubilizing agent is viable in enhancing iron bioavailability.
Interventions
DIETARY_SUPPLEMENTReference meal 1
1 ml Ferrous sulfate solution (4mgFe/ml) was added in cooked comercial Rice Prior to served to participant. The meal served with 30 g mixed vegetable Sauce and 300 ml nanopure water
DIETARY_SUPPLEMENTReference 2
1 ml Ferrous sulphate solution (4mgFe/ml) was added in cooked comercial Rice Prior to served to participant. The meal served with 30 g bean Sauce and 300 ml nanopure water
DIETARY_SUPPLEMENTTest meal A
Fortified extruded Rice was mixed with Commercial Rice (mixing Ratio: 1:100) The meal served with 30 g vegetable Sauce and 300 ml nanopure water. \*\* composition of extruded Rice: Ferric pyrophosphate, zinc oxide and ethylenediaminetetraacetic acid
DIETARY_SUPPLEMENTTest meal B
Fortified extruded Rice was mixed with Commercial Rice (mixing Ratio: 1:100) The meal served with 30 g vegetable Sauce and 300 ml nanopure water. \*\* composition of extruded Rice: Ferric pyrophosphate, zinc sulfate and ethylenediaminetetraacetic acid
DIETARY_SUPPLEMENTTest meal C
Fortified extruded Rice was mixed with Commercial Rice (mixing Ratio: 1:100) The meal served with 30 g vegetable Sauce and 300 ml nanopure water. \*\* composition of extruded Rice: Ferric pyrophosphate, zinc sulfate, citric acid and trisodium Citrate.
DIETARY_SUPPLEMENTTest meal D
Fortified extruded Rice was mixed with Commercial Rice (mixing Ratio: 1:100) The meal served with 30 g vegetable Sauce and 300 ml nanopure water. \*\* composition of extruded Rice: Ferric pyrophosphate, zinc sulfate and sodium pyrophosphate.
DIETARY_SUPPLEMENTTest meal E
Fortified extruded Rice was mixed with Commercial Rice (mixing Ratio: 1:100) The meal served with 30 g bean Sauce and 300 ml nanopure water. \*\* composition of extruded Rice: Ferric pyrophosphate, zinc sulfate, citric acid and trisodium Citrate.
Sponsors
Swiss Federal Institute of Technology
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Female, 18 to 40 years old * Normal body Mass Index (18.5 - 25 kg/m2) * Body weight ≤ 65 kg * Signed informed consent
Exclusion criteria
* Pregnancy (assessed by self-declaration) * Lactating up to 6 weeks before study initiation * Anaemia (Hb \< 12.0 g/dL) * Elevate CRP (\>5.0 mg/L) * Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement) * Continuous/long-term use of medication during the whole study (except for contraceptives) * Consumption of mineral and vitamin supplements within 2 weeks prior to 1st meal administration * Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months * Earlier participation in a study using Fe stable isotopes or participation in any clinical study within the last 30 days * Participant who cannot be expected to comply with study protocol (e.g. not available on certain study appointments) * Smokers (\> 1 cigarette per week) * Difficulties with blood sampling * Male gender * Do not understand English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the isotopic ratio of iron in blood at week 2 | baseline, 2 weeks | The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes. |
| Change from week 2 in the isotopic ratio of iron in blood at week 4 | 2 weeks, 4 weeks | The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes. |
| Change from week 4 in the isotopic ratio of iron in blood at week 6 | 4 weeks, 6 weeks | The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes. |
| Change from week 6 in the isotopic ratio of iron in blood at week 8 | 6 weeks, 8 weeks | The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes. |
| Change from week 8 in the isotopic ratio of iron in blood at week 10 | 8 weeks, 10 weeks | The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Haemoglobin | 2, 4,6,8 and 10 weeks | Haemoglobin of each timepoint |
| Plasma Ferritin | 2, 4, 6, 8 and 10 weeks | Plasma Ferritin of each timepoint |
| Inflammation Marker | 2, 4, 6, 8 and 10 weeks | Plasma Ferririn of each timepoint |
Countries
Switzerland
Outcome results
None listed