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Iron Absorption From Fortified Extruded Rice Using Different Extruding Temperatures.

Primary Purpose

Iron-deficiency

Status

Unknown status

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Reference meal

Test meal A

Test meal B

Test meal C

Test meal D

Test meal E

Test meal F

About this trial

This is an interventional prevention trial for Iron-deficiency focused on measuring Iron deficiency, iron fortified rice, extruded rice

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Human Nutrition Laboratory, ETH Zurich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Reference meal

Test meal A

Test meal B

Test meal C

Test meal D

Test meal E

Test meal F

Arm Description

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.

Commercial Rice was mixed with cold-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce.

Commercial Rice was mixed with warm-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce.

Commercial Rice was mixed with hot-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce.

Commercial Rice was mixed with cold-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce.

Commercial Rice was mixed with warm-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce.

Commercial Rice was mixed with hot-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

Secondary Outcome Measures

Haemoglobin

Haemoglobin of each timepoint

Plasma Ferritin

Plasma Ferritin of each timepoint

Inflammation marker

Plasma Ferririn of each timepoint

Full Information

NCT ID

NCT03703726

First Posted

October 8, 2018

Last Updated

October 11, 2018

Sponsor

Swiss Federal Institute of Technology

1. Study Identification

Unique Protocol Identification Number

NCT03703726

Brief Title

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

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 25, 2018 (Actual)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Swiss Federal Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Iron-deficiency

Keywords

Iron deficiency, iron fortified rice, extruded rice

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Reference meal

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Test meal A

Arm Type

Experimental

Arm Description

Commercial Rice was mixed with cold-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce.

Arm Title

Test meal B

Arm Type

Active Comparator

Arm Description

Commercial Rice was mixed with warm-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce.

Arm Title

Test meal C

Arm Type

Experimental

Arm Description

Commercial Rice was mixed with hot-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce.

Arm Title

Test meal D

Arm Type

Experimental

Arm Description

Commercial Rice was mixed with cold-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce.

Arm Title

Test meal E

Arm Type

Active Comparator

Arm Description

Commercial Rice was mixed with warm-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce.

Arm Title

Test meal F

Arm Type

Active Comparator

Arm Description

Commercial Rice was mixed with hot-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce.

Intervention Type

Dietary Supplement

Intervention Name(s)

Reference meal

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Test meal A

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Test meal B

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Test meal C

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Test meal D

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Test meal E

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Test meal F

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from baseline in the isotopic ratio of iron in blood at week 2

Description

The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

Time Frame

baseline, 2 weeks

Title

Change from week 2 in the isotopic ratio of iron in blood at week 4

Description

The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

Time Frame

2 weeks, 4 weeks

Title

Change from week 4 in the isotopic ratio of iron in blood at week 6

Description

The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

Time Frame

4 weeks, 6 weeks

Title

Change from week 6 in the isotopic ratio of iron in blood at week 8

Description

The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

Time Frame

6 weeks, 8 weeks

Title

Change from week 8 in the isotopic ratio of iron in blood at week 10

Description

The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

Time Frame

8 weeks, 10 weeks

Secondary Outcome Measure Information:

Title

Haemoglobin

Description

Haemoglobin of each timepoint

Time Frame

2, 4,6,8 and 10 weeks

Title

Plasma Ferritin

Description

Plasma Ferritin of each timepoint

Time Frame

2, 4, 6, 8 and 10 weeks

Title

Inflammation marker

Description

Plasma Ferririn of each timepoint

Time Frame

2, 4, 6, 8 and 10 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Human Nutrition Laboratory, ETH Zurich

City

Zürich

ZIP/Postal Code

8092

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

34967894

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.

Results Reference

derived

Learn more about this trial

Iron Absorption From Fortified Extruded Rice Using Different Extruding Temperatures.

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