Iron Absorption From Fortified Extruded Rice Using Different Extruding Temperatures.

Iron-deficiency Clinical Trial

Official title:

Effect of Processing Temperature on Iron Absorption From Iron Fortified Rice in Young Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03703726
• Other study ID #: Iron_ExtrudedRice
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 25, 2018
• Est. completion date: December 2018

Study information

• Verified date: October 2018
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron-deficiency

Intervention

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.
• 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.
• 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
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Switzerland	Human Nutrition Laboratory, ETH Zurich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Haemoglobin	Haemoglobin of each timepoint	2, 4,6,8 and 10 weeks
Secondary	Plasma Ferritin	Plasma Ferritin of each timepoint	2, 4, 6, 8 and 10 weeks
Secondary	Inflammation marker	Plasma Ferririn of each timepoint	2, 4, 6, 8 and 10 weeks