Iron Absorption From Fortified Extruded Rice Using Different Extruding Temperatures.

• ClinicalTrials.gov Identifier: NCT03703726
• Recruitment Status: Unknown
• First Posted: October 12, 2018
• Last Update Posted: October 12, 2018
• Sponsor: Swiss Federal Institute of Technology
• Information provided by (Responsible Party): Swiss Federal Institute of Technology

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.

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.

Condition or disease	Intervention/treatment	Phase
Iron-deficiency	Dietary Supplement: Reference meal; Dietary Supplement: Test meal A; Dietary Supplement: Test meal B; Dietary Supplement: Test meal C; Dietary Supplement: Test meal D; Dietary Supplement: Test meal E; Dietary Supplement: Test meal F	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Effect of Processing Temperature on Iron Absorption From Iron Fortified Rice in Young Women
• Actual Study Start Date: September 25, 2018
• Estimated Primary Completion Date: December 2018
• Estimated Study Completion Date: December 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	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.
Experimental: Test meal A; 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; 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.
Active Comparator: Test meal B; 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; 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
Experimental: Test meal C; 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; 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.
Experimental: Test meal D; 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; 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.
Active Comparator: Test meal E; 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; 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.
Active Comparator: Test meal F; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Change from baseline in the isotopic ratio of iron in blood at week 2 [ Time Frame: baseline, 2 weeks ]
   The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
2. Change from week 2 in the isotopic ratio of iron in blood at week 4 [ Time Frame: 2 weeks, 4 weeks ]
   The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
3. Change from week 4 in the isotopic ratio of iron in blood at week 6 [ Time Frame: 4 weeks, 6 weeks ]
   The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
4. Change from week 6 in the isotopic ratio of iron in blood at week 8 [ Time Frame: 6 weeks, 8 weeks ]
   The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
5. Change from week 8 in the isotopic ratio of iron in blood at week 10 [ Time Frame: 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 :

1. Haemoglobin [ Time Frame: 2, 4,6,8 and 10 weeks ]
   Haemoglobin of each timepoint
2. Plasma Ferritin [ Time Frame: 2, 4, 6, 8 and 10 weeks ]
   Plasma Ferritin of each timepoint
3. Inflammation marker [ Time Frame: 2, 4, 6, 8 and 10 weeks ]
   Plasma Ferririn of each timepoint

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Switzerland

Human Nutrition Laboratory, ETH Zurich

Zürich, Switzerland, 8092

Sponsors and Collaborators

Swiss Federal Institute of Technology

More Information

• Responsible Party: Swiss Federal Institute of Technology
• ClinicalTrials.gov Identifier: NCT03703726
• Other Study ID Numbers: Iron_ExtrudedRice
• First Posted: October 12, 2018
• Last Update Posted: October 12, 2018
• Last Verified: October 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Swiss Federal Institute of Technology:

Iron deficiency; iron fortified rice; extruded rice

Additional relevant MeSH terms:

Anemia, Iron-Deficiency; Anemia, Hypochromic; Anemia; Hematologic Diseases; Iron Metabolism Disorders; Metabolic Diseases