Iron Absorption From Fortified Extruded Rice Using Different Extruding Temperatures.

Federal Institute of Technology (ETH) Zurich

Status: Unknown

Conditions: Iron-deficiency

Treatments: Dietary Supplement: Reference meal; Dietary Supplement: Test meal E; Dietary Supplement: Test meal C; Dietary Supplement: Test meal F; Dietary Supplement: Test meal B; Dietary Supplement: Test meal A; Dietary Supplement: Test meal D

Study type: Interventional

Funder types: Other

Identifiers

NCT03703726

Iron_ExtrudedRice

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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22 participants in 7 patient groups

Reference meal

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Reference meal

Test meal A

Experimental group

Description:

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

Treatment:

Dietary Supplement: Test meal A

Test meal B

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Test meal B

Test meal C

Experimental group

Description:

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

Treatment:

Dietary Supplement: Test meal C

Test meal D

Experimental group

Description:

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

Treatment:

Dietary Supplement: Test meal D

Test meal E

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Test meal E

Test meal F

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Test meal F