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

Not Applicable

• Conditions: Iron-deficiency

• Registration Number: NCT03703739
• Lead Sponsor: Swiss Federal Institute of Technology

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-10
• Study Start: 2018-10-02
• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-11
• Last Update Submitted: 2018-10-11
• Study First Posted: 2018-10-12
• Last Update Posted: 2018-10-12
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 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 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.
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.

Secondary Outcome Measures

Name	Time	Method
Plasma Ferritin	2, 4, 6, 8 and 10 weeks	Plasma Ferritin of each timepoint
Haemoglobin	2, 4,6,8 and 10 weeks	Haemoglobin of each timepoint
Inflammation Marker	2, 4, 6, 8 and 10 weeks	Plasma Ferririn of each timepoint

Trial Locations

Locations (1)

Human Nutrition Laboratory, ETH Zurich; 🇨🇭 Zürich, Switzerland