Evaluation of the Use of Plasma Zinc Concentration for Assessing the Impact of Targeted and Mass Zinc Fortification Programs
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Plasma zinc concentration
研究概览
简要总结
The purpose of the study is to evaluate the use of plasma zinc concentration for assessing the impact of mass zinc fortification programs.
详细描述
The objectives of the present study are to determine whether plasma zinc concentration changes in response to additional zinc consumption, as provided by zinc-fortified cereal-based complementary foods fed to adult men (fortified at a level consistent with currently proposed levels). The following specific steps will be completed:
- Zinc-fortified breads prepared from zinc-fortified wheat flour will be developed with assistance from experts in food technology.
- A four-week feeding trial will be implemented to assess the change in plasma zinc concentration among young adult men who receive: a) bread fortified with a moderate amount of zinc and a liquid vitamin preparation between meals; b) bread fortified with a large amount zinc and a liquid vitamin preparation between meals; c) non-zinc-fortified bread and a liquid vitamin preparation between meals [negative control group]; and d) non-zinc-fortified bread and a zinc-containing liquid vitamin preparation between meals [positive control group].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •apparently healthy males
排除标准
- •Hemoglobin <80 g/L
研究组 & 干预措施
Non-fortified group
Daily consumption of non-fortified bread and a placebo supplement for 1 month.
干预措施: Non-fortified bread (Dietary Supplement)
Non-fortified group
Daily consumption of non-fortified bread and a placebo supplement for 1 month.
干预措施: Placebo supplement (Dietary Supplement)
Zinc supplemented group
Daily consumption of non-fortified bread and daily intake of zinc supplement (10 mg zinc/d)
干预措施: Non-fortified bread (Dietary Supplement)
Zinc-fortified bread (10 mg zinc/d)
Daily consumption of zinc fortified bread for 1 month
干预措施: Zinc-fortified bread (Dietary Supplement)
Zinc-fortified bread (10 mg zinc/d)
Daily consumption of zinc fortified bread for 1 month
干预措施: Placebo supplement (Dietary Supplement)
Zinc fortified bread (20 mg zinc/d)
Daily consumption of zinc fortified bread for 1 month.
干预措施: Zinc-fortified bread (Dietary Supplement)
Zinc fortified bread (20 mg zinc/d)
Daily consumption of zinc fortified bread for 1 month.
干预措施: Placebo supplement (Dietary Supplement)
Zinc supplemented group
Daily consumption of non-fortified bread and daily intake of zinc supplement (10 mg zinc/d)
干预措施: Zinc supplement (Dietary Supplement)
结局指标
主要结局
Plasma zinc concentration
时间窗: 1 month
次要结局
未报告次要终点