Iron Absorption From Fortified Extruded Rice Using Different Extruding Temperatures.

Study Overview
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Brief Summary
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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. Hot and cold extrusion, have been identified as the major methods for rice fortification. Extruded rice has the advantage of incorporating vitamins and minerals into the food matrix. Cold, warm and hot extrusion differ in the processing temperature and the physical structure of fortified rice kernel matrix. A recent human study in young women showed fractional iron absorption was higher in cold extruded rice compared to hot extruded Rice and this was associated with changes in the starch microstructure. These changes cannot be detected in warm extruded rice, thus, our aim is to test the iron bioavailability in difference extrusion methods; hot and warm and cold with and without the solubilizing agent CA/TSC. This will provide information on optimized rice formulations for optimal iron delivery.

Official Title
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Effect of Processing Temperature on Iron Absorption From Iron Fortified Rice in Young Women

Conditions
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Iron-deficiency

Intervention / Treatment
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* Dietary Supplement: Reference meal
* Dietary Supplement: Test meal A
* Dietary Supplement: Test meal B
* Dietary Supplement: Test meal C
* Dietary Supplement: Test meal D
* Dietary Supplement: Test meal E
* Dietary Supplement: Test meal F


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reference meal<br>50 g of Commercial Rice was cooked and 4 mg iron from Ferrous sulphate was added Prior to give to participants. Rice meal consumed with mixed vegetable Sauce. | Dietary Supplement: Reference meal<br>* 50 g of Commercial Rice (Jasmin Rice) (dry weight) was cooked and 4 mg iron from Ferrous sulphate was added Prior to give to participants. Rice meal consumed with mixed vegetable Sauce.<br>|
| Experimental: Test meal A<br>Commercial Rice was mixed with cold-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce. | Dietary Supplement: Test meal A<br>* Commercial Rice (Jasmin Rice) was mixed with iron fortified extruded rice co-fortified with zinc sulfate, Rice meal consumed with mixed vegetable Sauce. Cold temperature extruding process (30-40 C°) was used to produce the extruded rice.<br>|
| Active Comparator: Test meal B<br>Commercial Rice was mixed with warm-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce. | Dietary Supplement: Test meal B<br>* Commercial Rice (Jasmin Rice) was mixed with iron fortified extruded rice co-fortified with zinc sulfate, Rice meal consumed with mixed vegetable Sauce. Warm temperature extruding process (60-70 C°) was used to produce the extruded rice<br>|
| Experimental: Test meal C<br>Commercial Rice was mixed with hot-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce. | Dietary Supplement: Test meal C<br>* Commercial Rice (Jasmin Rice) was mixed with iron fortified extruded rice co-fortified with zinc sulfate, Rice meal consumed with mixed vegetable Sauce. Hot temperature extruding process (80-100 °C) was used to produce the extruded rice.<br>|
| Experimental: Test meal D<br>Commercial Rice was mixed with cold-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce. | Dietary Supplement: Test meal D<br>* Commercial Rice (Jasmin Rice) was mixed with iron fortified extruded rice co-fortified with zinc sulfate,citric acid and trisodium Citrate. Rice meal consumed with mixed vegetable Sauce. Cold temperature extruding process (30-40 C°) was used to produce the extruded rice.<br>|
| Active Comparator: Test meal E<br>Commercial Rice was mixed with warm-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce. | Dietary Supplement: Test meal E<br>* Commercial Rice (Jasmin Rice) was mixed with iron fortified extruded rice co-fortified with zinc sulfate,citric acid and trisodium Citrate. Rice meal consumed with mixed vegetable Sauce. warm temperature extruding process (60-70 C°) was used to produce the extruded rice.<br>|
| Active Comparator: Test meal F<br>Commercial Rice was mixed with hot-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce. | Dietary Supplement: Test meal F<br>* Commercial Rice (Jasmin Rice) was mixed with iron fortified extruded rice co-fortified with zinc sulfate,citric acid and trisodium Citrate. Rice meal consumed with mixed vegetable Sauce. Hot temperature extruding process (80-100 C°) was used to produce the extruded rice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin | Haemoglobin of each timepoint | 2, 4,6,8 and 10 weeks | 
| Plasma Ferritin | Plasma Ferritin of each timepoint | 2, 4, 6, 8 and 10 weeks | 
| Inflammation marker | Plasma Ferririn of each timepoint | 2, 4, 6, 8 and 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iron deficiency, iron fortified rice, extruded rice