NCT03703726

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

Status unknown NA Last updated 11 October 2018

What this trial tests

NA trial testing Reference meal in Iron-deficiency in 22 participants. Status unknown.

Timeline

25 September 2018

Primary endpoint
1 December 2018

1 December 2018

Quick facts

Lead sponsor	Swiss Federal Institute of Technology
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	prevention
Enrollment	22
Start date	25 September 2018
Primary completion	1 December 2018
Estimated completion	1 December 2018
Sites	1 location across Switzerland

Drugs / interventions tested

• Reference meal
• Test meal A
• Test meal B
• Test meal C
• Test meal D
• Test meal E
• Test meal F

Conditions studied

• Iron-deficiency — all drugs for Iron-deficiency →

Sponsor

Swiss Federal Institute of Technology

Who can join

Adults 18 to 40, female only, with Iron-deficiency. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change from baseline in the isotopic ratio of iron in blood at week 2
  Time frame: 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 2 in the isotopic ratio of iron in blood at week 4
  Time frame: 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
  Time frame: 4 weeks, 6 weeks
  The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
• Change from week 6 in the isotopic ratio of iron in blood at week 8
  Time frame: 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 week 8 in the isotopic ratio of iron in blood at week 10
  Time frame: 8 weeks, 10 weeks
  The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Scheuchzer P, Zimmerman MB, Zeder C, Sánchez-Ferrer A, et al · · 2022 · cited 6× · PMID 34967894 · DOI 10.1093/jn/nxab435