Clinical trial NCT03703739: Iron Absorption From Iron Fortified Extruded Rice Co-fortified With Various Solubilizing Agents
Official title: Effect of Solubilizing Agents on Iron Absorption From Iron Fortified Rice in Young Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Iron-deficiency
Keywords: Iron deficiency
iron fortified rice
extruded rice
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the isotopic ratio of iron in blood at week 2
timeFrame: baseline, 2 weeks
measure: Change from week 2 in the isotopic ratio of iron in blood at week 4
timeFrame: 2 weeks, 4 weeks
measure: Change from week 4 in the isotopic ratio of iron in blood at week 6
timeFrame: 4 weeks, 6 weeks
measure: Change from week 6 in the isotopic ratio of iron in blood at week 8
timeFrame: 6 weeks, 8 weeks
measure: Change from week 8 in the isotopic ratio of iron in blood at week 10
timeFrame: 8 weeks, 10 weeks
Secondary outcomes:
measure: Haemoglobin
timeFrame: 2, 4,6,8 and 10 weeks
measure: Plasma Ferritin
timeFrame: 2, 4, 6, 8 and 10 weeks
measure: Inflammation Marker
timeFrame: 2, 4, 6, 8 and 10 weeks
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Human Nutrition Laboratory, ETH Zurich
Study officials:
References: