Iron Absorption From Fortified Extruded Rice Using Different Extruding Temperatures.

NCT03703726 | Unknown

• 1 other identifier: Iron_ExtrudedRice
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron-deficiency

Keywords

Iron deficiency; iron fortified rice; extruded rice

Outcome Measures

Primary Outcomes (5)

• 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.

  baseline, 2 weeks

• 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.

  2 weeks, 4 weeks

• 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.

  4 weeks, 6 weeks

• 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.

  6 weeks, 8 weeks

• 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.

  8 weeks, 10 weeks

Secondary Outcomes (3)

• Haemoglobin

  2, 4,6,8 and 10 weeks

• Plasma Ferritin

  2, 4, 6, 8 and 10 weeks

• Inflammation marker

  2, 4, 6, 8 and 10 weeks

Study Arms (7)

Reference meal

ACTIVE COMPARATOR

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

Test meal A

EXPERIMENTAL

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

Test meal B

ACTIVE COMPARATOR

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

Test meal C

EXPERIMENTAL

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

Test meal D

EXPERIMENTAL

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

Test meal E

ACTIVE COMPARATOR

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

Test meal F

ACTIVE COMPARATOR

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

Interventions

Reference meal 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.

Reference meal

Test meal A 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 A

Test meal B 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 B

Test meal C 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 C

Test meal D 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 D

Test meal E 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 E

Test meal F 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.

Test meal F

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female, 18 to 40 years old
• Normal body Mass Index (18.5 - 25 kg/m2)
• Body weight ≤ 65 kg
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead

Study Sites (1)

Human Nutrition Laboratory, ETH Zurich

Zurich, 8092, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 34967894 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Deficiencies

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 12, 2018
• Study Start: September 25, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 12, 2018

Record last verified: 2018-10

Locations

CH (1)