An interventional study of Reference meal 1 and Reference 2 in Iron-deficiency, sponsored by Swiss Federal Institute of Technology. Status unknown at 1 site in Switzerland. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-12.
Sponsored by Swiss Federal Institute of Technology · Not applicable, Interventional, and Prevention
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.
644 studies on the registry are indexed under Anemia, Iron-Deficiency; 105 are open to participants now.
This study's enrollment of 22 is below the median of 100 across 503 interventional studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →Swiss Federal Institute of Technology is the lead sponsor of 152 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
50 g of Commercial Rice (Jasmin Rice) (dry weight) was cooked and 4 mg iron from Ferrous sulfate was added Prior to give to participants. Rice meal consumed with mixed vegetable Sauce.
Dietary Supplement: Reference meal 1
50 g of Commercial Rice (Jasmin Rice) (dry weight) was cooked and 4 mg iron from Ferrous sulfate was added Prior to give to participants. Rice meal consumed with bean sauce.
Dietary Supplement: Reference 2
Commercial Rice (Jasmin Rice) was mixed with iron fortified extuded rice cofortified with zinc oxide and ethylenediaminetetraacetic acid (mixing ratio 100:1), Rice meal consumed with mixed vegetable Sauce.
Dietary Supplement: Test meal A
Commercial Rice (Jasmin Rice) was mixed with iron fortified extuded rice co-fortified with zinc sulfate and ethylenediaminetetraacetic acid (mixing ratio 100:1), Rice meal consumed with mixed vegetable Sauce.
Dietary Supplement: Test meal B
Commercial Rice (Jasmin Rice) was mixed with iron fortified extuded rice co-fortified with zinc sulfate, citric acid and trisodium citrate (mixing ratio 100:1), Rice meal consumed with mixed vegetable Sauce.
Dietary Supplement: Test meal C
Commercial Rice (Jasmin Rice) was mixed with iron fortified extuded rice co-fortified with zinc sulfafe and sodium pyrophosphate (mixing ratio 100:1), Rice meal consumed with mixed vegetable Sauce.
Dietary Supplement: Test meal D
Commercial Rice (Jasmin Rice) was mixed with iron fortified extuded rice co-fortified with zinc sulfate, citric acid and trisodium citrate (mixing ratio 100:1), Rice meal consumed with bean Sauce.
Dietary Supplement: Test meal E
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
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
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
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
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.
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.
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.
Change from baseline in the isotopic ratio of iron in blood at week 2
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Time frame: baseline, 2 weeks
Change from week 2 in the isotopic ratio of iron in blood at week 4
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Time frame: 2 weeks, 4 weeks
Change from week 4 in the isotopic ratio of iron in blood at week 6
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Time frame: 4 weeks, 6 weeks
Change from week 6 in the isotopic ratio of iron in blood at week 8
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Time frame: 6 weeks, 8 weeks
Change from week 8 in the isotopic ratio of iron in blood at week 10
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Time frame: 8 weeks, 10 weeks
Haemoglobin
Haemoglobin of each timepoint
Time frame: 2, 4,6,8 and 10 weeks
Plasma Ferritin
Plasma Ferritin of each timepoint
Time frame: 2, 4, 6, 8 and 10 weeks
Inflammation Marker
Plasma Ferririn of each timepoint
Time frame: 2, 4, 6, 8 and 10 weeks
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Swiss Federal Institute of Technology