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Iron Absorption From Iron Fortified Extruded Rice Co-fortified With Various Solubilizing Agents

Primary Purpose

Iron-deficiency

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Reference meal 1
Reference 2
Test meal A
Test meal B
Test meal C
Test meal D
Test meal E
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Reference meal 1

Reference 2

Test meal A

Test meal B

Test meal C

Test meal D

Test meal E

Arm Description

50 g of Commercial Rice (Jasmin Rice) (dry weight) was cooked and 4 mg iron from Ferrous sulfate was added Prior to give to participants. Rice meal consumed with mixed vegetable Sauce.

50 g of Commercial Rice (Jasmin Rice) (dry weight) was cooked and 4 mg iron from Ferrous sulfate was added Prior to give to participants. Rice meal consumed with bean sauce.

Commercial Rice (Jasmin Rice) was mixed with iron fortified extuded rice cofortified with zinc oxide and ethylenediaminetetraacetic acid (mixing ratio 100:1), Rice meal consumed with mixed vegetable Sauce.

Commercial Rice (Jasmin Rice) was mixed with iron fortified extuded rice co-fortified with zinc sulfate and ethylenediaminetetraacetic acid (mixing ratio 100:1), Rice meal consumed with mixed vegetable Sauce.

Commercial Rice (Jasmin Rice) was mixed with iron fortified extuded rice co-fortified with zinc sulfate, citric acid and trisodium citrate (mixing ratio 100:1), Rice meal consumed with mixed vegetable Sauce.

Commercial Rice (Jasmin Rice) was mixed with iron fortified extuded rice co-fortified with zinc sulfafe and sodium pyrophosphate (mixing ratio 100:1), Rice meal consumed with mixed vegetable Sauce.

Commercial Rice (Jasmin Rice) was mixed with iron fortified extuded rice co-fortified with zinc sulfate, citric acid and trisodium citrate (mixing ratio 100:1), Rice meal consumed with bean 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

First Posted
October 8, 2018
Last Updated
October 11, 2018
Sponsor
Swiss Federal Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03703739
Brief Title
Iron Absorption From Iron Fortified Extruded Rice Co-fortified With Various Solubilizing Agents
Official Title
Effect of Solubilizing Agents 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
October 2, 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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. Ferric pyrophosphate (FePP) is an acceptable iron compound for rice fortification, due to its white colour and low reactivity with the rice matrix. However, iron from FePP generally has a low bioavailability. To increase the low iron bioavailability of FePP in fortified rice, ligands acting as solubilizing agents have been suggested, such as citric acid/trisodium citrate (CA/TSC), ethylenediaminetetraacetic acid (EDTA) and sodium pyrophosphate (NaPP). It is however unclear to which extent CA/TSC would enhance iron bioavailability in presence of phytic acid, a common inhibitor of iron absorption found in whole grains and legumes. Zinc oxide reduces iron bioavailability from FePP with and without CA/TSC, in contrast to Zinc sulphate. It is however unclear if this decrease would be also expected in presence of EDTA as solubilizing agent. Further, NaPP has been suggested as a solubilizing agent, enhancing the bioavailability from FePP in bouillon cubes. This study aim to test its effect in rice. Meals containing a high (bean sauce) and low (mixed vegetable) phytic acid level sauce will be used to simulated varying dietary backgrounds, allowing to answer the question which solubilizing agent is viable in enhancing iron bioavailability.

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 1
Arm Type
Active Comparator
Arm Description
50 g of Commercial Rice (Jasmin Rice) (dry weight) was cooked and 4 mg iron from Ferrous sulfate was added Prior to give to participants. Rice meal consumed with mixed vegetable Sauce.
Arm Title
Reference 2
Arm Type
Active Comparator
Arm Description
50 g of Commercial Rice (Jasmin Rice) (dry weight) was cooked and 4 mg iron from Ferrous sulfate was added Prior to give to participants. Rice meal consumed with bean sauce.
Arm Title
Test meal A
Arm Type
Experimental
Arm Description
Commercial Rice (Jasmin Rice) was mixed with iron fortified extuded rice cofortified with zinc oxide and ethylenediaminetetraacetic acid (mixing ratio 100:1), Rice meal consumed with mixed vegetable Sauce.
Arm Title
Test meal B
Arm Type
Experimental
Arm Description
Commercial Rice (Jasmin Rice) was mixed with iron fortified extuded rice co-fortified with zinc sulfate and ethylenediaminetetraacetic acid (mixing ratio 100:1), Rice meal consumed with mixed vegetable Sauce.
Arm Title
Test meal C
Arm Type
Experimental
Arm Description
Commercial Rice (Jasmin Rice) was mixed with iron fortified extuded rice co-fortified with zinc sulfate, citric acid and trisodium citrate (mixing ratio 100:1), Rice meal consumed with mixed vegetable Sauce.
Arm Title
Test meal D
Arm Type
Experimental
Arm Description
Commercial Rice (Jasmin Rice) was mixed with iron fortified extuded rice co-fortified with zinc sulfafe and sodium pyrophosphate (mixing ratio 100:1), Rice meal consumed with mixed vegetable Sauce.
Arm Title
Test meal E
Arm Type
Experimental
Arm Description
Commercial Rice (Jasmin Rice) was mixed with iron fortified extuded rice co-fortified with zinc sulfate, citric acid and trisodium citrate (mixing ratio 100:1), Rice meal consumed with bean Sauce.
Intervention Type
Dietary Supplement
Intervention Name(s)
Reference meal 1
Intervention Description
1 ml Ferrous sulfate solution (4mgFe/ml) was added in cooked comercial Rice Prior to served to participant. The meal served with 30 g mixed vegetable Sauce and 300 ml nanopure water
Intervention Type
Dietary Supplement
Intervention Name(s)
Reference 2
Intervention Description
1 ml Ferrous sulphate solution (4mgFe/ml) was added in cooked comercial Rice Prior to served to participant. The meal served with 30 g bean Sauce and 300 ml nanopure water
Intervention Type
Dietary Supplement
Intervention Name(s)
Test meal A
Intervention Description
Fortified extruded Rice was mixed with Commercial Rice (mixing Ratio: 1:100) The meal served with 30 g vegetable Sauce and 300 ml nanopure water. ** composition of extruded Rice: Ferric pyrophosphate, zinc oxide and ethylenediaminetetraacetic acid
Intervention Type
Dietary Supplement
Intervention Name(s)
Test meal B
Intervention Description
Fortified extruded Rice was mixed with Commercial Rice (mixing Ratio: 1:100) The meal served with 30 g vegetable Sauce and 300 ml nanopure water. ** composition of extruded Rice: Ferric pyrophosphate, zinc sulfate and ethylenediaminetetraacetic acid
Intervention Type
Dietary Supplement
Intervention Name(s)
Test meal C
Intervention Description
Fortified extruded Rice was mixed with Commercial Rice (mixing Ratio: 1:100) The meal served with 30 g vegetable Sauce and 300 ml nanopure water. ** composition of extruded Rice: Ferric pyrophosphate, zinc sulfate, citric acid and trisodium Citrate.
Intervention Type
Dietary Supplement
Intervention Name(s)
Test meal D
Intervention Description
Fortified extruded Rice was mixed with Commercial Rice (mixing Ratio: 1:100) The meal served with 30 g vegetable Sauce and 300 ml nanopure water. ** composition of extruded Rice: Ferric pyrophosphate, zinc sulfate and sodium pyrophosphate.
Intervention Type
Dietary Supplement
Intervention Name(s)
Test meal E
Intervention Description
Fortified extruded Rice was mixed with Commercial Rice (mixing Ratio: 1:100) The meal served with 30 g bean Sauce and 300 ml nanopure water. ** composition of extruded Rice: Ferric pyrophosphate, zinc sulfate, citric acid and trisodium Citrate.
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
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

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Iron Absorption From Iron Fortified Extruded Rice Co-fortified With Various Solubilizing Agents

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