Effect of Solubilizing Agents on Iron Absorption From Iron Fortified Rice in Young Women
试验速览
- 阶段
- 不适用
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change from week 6 in the isotopic ratio of iron in blood at week 8
研究概览
简要总结
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. Ferric pyrophosphate (FePP) is an acceptable iron compound for rice fortification, due to its white colour and low reactivity with the rice matrix. However, iron from FePP generally has a low bioavailability. To increase the low iron bioavailability of FePP in fortified rice, ligands acting as solubilizing agents have been suggested, such as citric acid/trisodium citrate (CA/TSC), ethylenediaminetetraacetic acid (EDTA) and sodium pyrophosphate (NaPP).
It is however unclear to which extent CA/TSC would enhance iron bioavailability in presence of phytic acid, a common inhibitor of iron absorption found in whole grains and legumes. Zinc oxide reduces iron bioavailability from FePP with and without CA/TSC, in contrast to Zinc sulphate. It is however unclear if this decrease would be also expected in presence of EDTA as solubilizing agent. Further, NaPP has been suggested as a solubilizing agent, enhancing the bioavailability from FePP in bouillon cubes. This study aim to test its effect in rice. Meals containing a high (bean sauce) and low (mixed vegetable) phytic acid level sauce will be used to simulated varying dietary backgrounds, allowing to answer the question which solubilizing agent is viable in enhancing iron bioavailability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, 18 to 40 years old
- •Normal body Mass Index (18.5 - 25 kg/m2)
- •Body weight ≤ 65 kg
- •Signed informed consent
排除标准
- •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
研究组 & 干预措施
Reference meal 1
50 g of Commercial Rice (Jasmin Rice) (dry weight) was cooked and 4 mg iron from Ferrous sulfate was added Prior to give to participants. Rice meal consumed with mixed vegetable Sauce.
干预措施: Reference meal 1 (Dietary Supplement)
Reference 2
50 g of Commercial Rice (Jasmin Rice) (dry weight) was cooked and 4 mg iron from Ferrous sulfate was added Prior to give to participants. Rice meal consumed with bean sauce.
干预措施: Reference 2 (Dietary Supplement)
Test meal A
Commercial Rice (Jasmin Rice) was mixed with iron fortified extuded rice cofortified with zinc oxide and ethylenediaminetetraacetic acid (mixing ratio 100:1), Rice meal consumed with mixed vegetable Sauce.
干预措施: Test meal A (Dietary Supplement)
Test meal B
Commercial Rice (Jasmin Rice) was mixed with iron fortified extuded rice co-fortified with zinc sulfate and ethylenediaminetetraacetic acid (mixing ratio 100:1), Rice meal consumed with mixed vegetable Sauce.
干预措施: Test meal B (Dietary Supplement)
Test meal C
Commercial Rice (Jasmin Rice) was mixed with iron fortified extuded rice co-fortified with zinc sulfate, citric acid and trisodium citrate (mixing ratio 100:1), Rice meal consumed with mixed vegetable Sauce.
干预措施: Test meal C (Dietary Supplement)
Test meal D
Commercial Rice (Jasmin Rice) was mixed with iron fortified extuded rice co-fortified with zinc sulfafe and sodium pyrophosphate (mixing ratio 100:1), Rice meal consumed with mixed vegetable Sauce.
干预措施: Test meal D (Dietary Supplement)
Test meal E
Commercial Rice (Jasmin Rice) was mixed with iron fortified extuded rice co-fortified with zinc sulfate, citric acid and trisodium citrate (mixing ratio 100:1), Rice meal consumed with bean Sauce.
干预措施: Test meal E (Dietary Supplement)
结局指标
主要结局
Change from week 6 in the isotopic ratio of iron in blood at week 8
时间窗: 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 baseline in the isotopic ratio of iron in blood at week 2
时间窗: 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 8 in the isotopic ratio of iron in blood at week 10
时间窗: 8 weeks, 10 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
时间窗: 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
时间窗: 4 weeks, 6 weeks
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
次要结局
- Plasma Ferritin(2, 4, 6, 8 and 10 weeks)
- Haemoglobin(2, 4,6,8 and 10 weeks)
- Inflammation Marker(2, 4, 6, 8 and 10 weeks)