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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 25, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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