Evaluation of Human Zinc Absorption From Wheat-based Meals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- Fractional zinc absorption from different wheat-based test meals
研究概览
简要总结
Study part 1 and 2 Assessment of Zn absorption from regular and biofortified wheat: stable isotope absorption studies in women of childbearing age consuming test meals prepared from either the biofortified Zn wheat, regular wheat or post-harvest fortified wheat at two different extraction rates.
Study part 3 Assessment of Zn absorption from intrinsically and extrinsically labeled wheat: stable isotope absorption studies in women of childbearing age, or men, consuming test meals prepared from either intrinsically labeled Zn biofortified wheat, regular wheat or post-harvest fortified wheat extrinsically labeled immediately before consumption.
详细描述
The overall goal of study part 1 and 2 is to evaluate and compare the fractional and absolute Zn absorption from biofortified wheat cultivar (60 ppm Zn) to regular wheat (28 ppm Zn) and to post harvest fortified wheat (60 ppm Zn) for a total of 3 test meals per study. The studies will be conducted with products based on wheat with high extraction rate (study part 1) and medium extraction rate (study part 2) in two separate groups of women of childbearing age.
The goal of study part 3 is to investigate the difference of absorption measurements between intrinsically and extrinsically labeled biofortified wheat. The label of the test meals will have the same nature as the fortificant itself (extrinsic vs intrinsic), for a total of 3 test meals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female, 18 to 45 years old (Study part 1 and 2). Female or male, 18 to 45 years old (Study part 3)
- •Body Mass Index in the range of 18.5 to 25 kg/m2
- •Signed informed consent
排除标准
- •Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, anemia, hepatitis, hypertension, cancer or cardiovascular diseases (according to the subjects own statement)
- •Gluten intolerance, celiac disease
- •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 test meal administration
- •Pregnancy (Urine pregnancy test shall be performed before each test meal administration)
- •Lactating
- •Earlier participation in a study using Zn stable isotopes or participation in any other clinical study within the last 30 days
结局指标
主要结局
Fractional zinc absorption from different wheat-based test meals
时间窗: 3 months
Fractional zinc absorption (in %) will be assessed with stable isotopes of zinc using a double isotope technique.
次要结局
- Zn and C-reactive protein concentration in plasma(3 months)
研究者
Prof. Michael B. Zimmermann
Prof. Dr.
Swiss Federal Institute of Technology