Effect of Processing Temperature 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 baseline in the isotopic ratio of iron in blood at week 2
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.
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.
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
Test meal E
Commercial Rice was mixed with warm-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce.
干预措施: Test meal E (Dietary Supplement)
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.
干预措施: Reference meal (Dietary Supplement)
Test meal A
Commercial Rice was mixed with cold-extruded fortified Rice (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 was mixed with warm-extruded fortified Rice (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 was mixed with hot-extruded fortified Rice (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 was mixed with cold-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce.
干预措施: Test meal D (Dietary Supplement)
Test meal F
Commercial Rice was mixed with hot-extruded fortified Rice (mixing Ratio: 100:1) Rice meal consumed with mixed vegetable Sauce.
干预措施: Test meal F (Dietary Supplement)
结局指标
主要结局
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 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.
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 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.
次要结局
- Haemoglobin(2, 4,6,8 and 10 weeks)
- Plasma Ferritin(2, 4, 6, 8 and 10 weeks)
- Inflammation marker(2, 4, 6, 8 and 10 weeks)