Clinical trial NCT03703726: Iron Absorption From Fortified Extruded Rice Using Different Extruding Temperatures.
Official title: Effect of Processing Temperature 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.

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.


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:
citation: Scheuchzer P, Zimmerman MB, Zeder C, Sanchez-Ferrer A, Moretti D. Higher Extrusion Temperature Induces Greater Formation of Less Digestible Type V and Retrograded Starch in Iron-Fortified Rice Grains But Does Not Affect Iron Bioavailability: Stable Isotope Studies in Young Women. J Nutr. 2022 May 5;152(5):1220-1227. doi: 10.1093/jn/nxab435.