Iron Absorption From Iron Fortified Extruded Rice Co-fortified With Various Solubilizing Agents

Iron-deficiency Clinical Trial

Official title:

Effect of Solubilizing Agents on Iron Absorption From Iron Fortified Rice in Young Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03703739
• Other study ID #: Iron_RiceSolubilizing
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2, 2018
• Est. completion date: December 2018

Study information

• Verified date: October 2018
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron-deficiency

Intervention

Dietary Supplement:
• Reference 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
• Reference 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
• Test 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
• Test 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
• Test 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.
• Test 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.
• Test 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.

Locations

Country	Name	City	State
Switzerland	Human Nutrition Laboratory, ETH Zurich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, 2 weeks
Primary	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.	2 weeks, 4 weeks
Primary	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.	4 weeks, 6 weeks
Primary	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.	6 weeks, 8 weeks
Primary	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.	8 weeks, 10 weeks
Secondary	Haemoglobin	Haemoglobin of each timepoint	2, 4,6,8 and 10 weeks
Secondary	Plasma Ferritin	Plasma Ferritin of each timepoint	2, 4, 6, 8 and 10 weeks
Secondary	Inflammation Marker	Plasma Ferririn of each timepoint	2, 4, 6, 8 and 10 weeks