The Effect of Encapsulation Material and Encapsulated Micronutrients on Iron Absorption in Iron Depleted Women Consuming Iron Fortified Bread.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 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 has shown to be efficacious to alleviate the burden of micronutrient deficiencies. Ensuring the bioavailability of iron and maintaining the sensory quality and stability of the fortified food and other added micronutrients remains a challenge. Soluble iron compounds cause minor organoleptic changes in foods but their bioavailability in man is rather low. Water-soluble iron compounds, such as ferrous sulphate (FeSO4), are the compounds in which the iron is most bioavailable; however, they often cause unfavorable sensory changes.
Encapsulation of iron has excellent potential for overcoming unwanted sensory changes and iodine losses in salt, while maintaining acceptable bioavailability. In the present project, we would like to investigate the iron bioavailability from a new formulation of encapsulated iron sulphate based on hyaluronic acid (HA) and a polymer from the eudragit family.
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
- •Marginal iron status (PF <25 ng/ml)
- •Body weight < 65 kg
- •Normal body Mass Index (18.5 - 25 kg/m2)
- •Signed informed consent
排除标准
- •Pregnancy (assessed by a pregnancy test) / intention to become pregnant
- •Lactating up to 6 weeks before study initiation
- •Moderate or severe anaemia (Hb < 9.0 g/dL)
- •Elevated C reactive Protein (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 or difficulties with blood sampling)
研究组 & 干预措施
encapsulated FeSO4 20%
wheat bread fortified with encapsulated FeSO4 in a microsphere with 20% Fe loading
干预措施: encapsulated FeSO4 20% (Dietary Supplement)
free FeSO4
wheat bread fortified with free FeSO4
干预措施: free FeSO4 (Dietary Supplement)
free FeSO4 and empty microspheres
wheat bread fortified with free FeSO4, and empty microspheres
干预措施: free FeSO4 and empty microspheres (Dietary Supplement)
free FeSO4 with eudragit polymer
wheat bread fortified with free FeSO4, and eudragit polymer
干预措施: free FeSO4 and eudragit polymer (Dietary Supplement)
free FeSO4 with Hyaluronic Acid
wheat bread fortified with free FeSO4, and hyaluronic acid
干预措施: free FeSO4 and hylauronic acid (Dietary Supplement)
encapsulated FeSO4 3.2%
wheat bread fortified with encapsulated FeSO4 in a microsphere with 3.2% Fe loading
干预措施: encapsulated FeSO4 3.2% (Dietary Supplement)
encapsulated FeSO4 3.2%, encap. Vitamin A
wheat bread fortified with encapsulated FeSO4 in a microsphere with 3.2% Fe loading, and encapsulated Vitamin A as microspheres
干预措施: encapsulated FeSO4 3.2%, encapsulated Vitamin A (Dietary Supplement)
encapsulated FeSO4 3.2%, encap. Vitamin A, free folicacid
wheat bread fortified with encapsulated FeSO4 as microsphere with 3.2% Fe loading, encapsulated Vitamin A as microspheres and free folic acid
干预措施: encapsulated FeSO4 3.2%, encapsulated Vitamin A, free Folic Acid (Dietary Supplement)
FeSO4 embedded in Hyaluronic Acid
wheat bread fortified with FeSO4 that is embedded in hyaluronic acid.
干预措施: FeSO4 embedded in Hyaluronic acid (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.
次要结局
- Plasma Ferritin(baseline, weeks 2, 4 and 6)
- Haemoglobin(baseline, weeks 2, 4 and 6)
- inflammation marker(baseline, weeks 2, 4 and 6)
