Iron Absorption From Fortified Extruded Rice Using Different Extruding Temperatures.

October 11, 2018 updated by: Swiss Federal Institute of Technology

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8092
        • Human Nutrition Laboratory, ETH Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Reference meal
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
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.
Experimental: Test meal A
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

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.
Active Comparator: Test meal B
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

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
Experimental: Test meal C
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

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.
Experimental: Test meal D
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

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.
Active Comparator: Test meal E
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

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.
Active Comparator: Test meal F
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 2 weeks
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.
2 weeks, 4 weeks
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.
4 weeks, 6 weeks
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.
6 weeks, 8 weeks
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.
8 weeks, 10 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Federal Institute of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2018

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 8, 2018

First Submitted That Met QC Criteria

October 11, 2018

First Posted (Actual)

October 12, 2018

Study Record Updates

Last Update Posted (Actual)

October 12, 2018

Last Update Submitted That Met QC Criteria

October 11, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Iron_ExtrudedRice

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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