Iron Absorption From Fortified Extruded Rice Using Different Extruding Temperatures.

Not Applicable

• Conditions: Iron-deficiency
• Interventions: Dietary Supplement: Reference meal; Dietary Supplement: Test meal A; Dietary Supplement: Test meal E; Dietary Supplement: Test meal C; Dietary Supplement: Test meal F; Dietary Supplement: Test meal D; Dietary Supplement: Test meal B

• Registration Number: NCT03703726
• Lead Sponsor: Swiss Federal Institute of Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-25
• Status Verified: 2018-10
• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-11
• Last Update Submitted: 2018-10-11
• Study First Posted: 2018-10-12
• Last Update Posted: 2018-10-12
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference meal	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.
Test meal A	Test meal A	Commercial Rice was mixed with cold-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce.
Test meal E	Test meal E	Commercial Rice was mixed with warm-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce.
Test meal C	Test meal C	Commercial Rice was mixed with hot-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce.
Test meal F	Test meal F	Commercial Rice was mixed with hot-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce.
Test meal D	Test meal D	Commercial Rice was mixed with cold-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce.
Test meal B	Test meal B	Commercial Rice was mixed with warm-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce.

Primary Outcome Measures

Name	Time	Method
Change from baseline in the isotopic ratio of iron in blood at week 2	baseline, 2 weeks	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	2 weeks, 4 weeks	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	4 weeks, 6 weeks	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	6 weeks, 8 weeks	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	8 weeks, 10 weeks	The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

Secondary Outcome Measures

Name	Time	Method
Haemoglobin	2, 4,6,8 and 10 weeks	Haemoglobin of each timepoint
Plasma Ferritin	2, 4, 6, 8 and 10 weeks	Plasma Ferritin of each timepoint
Inflammation marker	2, 4, 6, 8 and 10 weeks	Plasma Ferririn of each timepoint

Trial Locations

Locations (1)

Human Nutrition Laboratory, ETH Zurich; 🇨🇭 Zürich, Switzerland