Iron Absorption From Fortified Extruded Rice Using Different Extruding Temperatures.

NCT ID: NCT03703726

Last Updated: 2018-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-25

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Iron-deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Reference meal

Intervention Type DIETARY_SUPPLEMENT

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.

Test meal A

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

Group Type EXPERIMENTAL

Test meal A

Intervention Type DIETARY_SUPPLEMENT

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.

Test meal B

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

Group Type ACTIVE_COMPARATOR

Test meal B

Intervention Type DIETARY_SUPPLEMENT

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

Test meal C

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

Group Type EXPERIMENTAL

Test meal C

Intervention Type DIETARY_SUPPLEMENT

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.

Test meal D

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

Group Type EXPERIMENTAL

Test meal D

Intervention Type DIETARY_SUPPLEMENT

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.

Test meal E

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

Group Type ACTIVE_COMPARATOR

Test meal E

Intervention Type DIETARY_SUPPLEMENT

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.

Test meal F

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

Group Type ACTIVE_COMPARATOR

Test meal F

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Human Nutrition Laboratory, ETH Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 34967894 (View on PubMed)

Other Identifiers

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Iron_ExtrudedRice

Identifier Type: -

Identifier Source: org_study_id

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