Efficacy and Safety of Heme-Iron Polypeptide on Improvement of Anemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes in hemoglobin
研究概览
简要总结
The investigators performed a 4-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Heme-Iron Polypeptide on Improvement of Anemia. The investigators measured Improvement of Anemia parameters , including hemoglobin, transferrin saturation, serum iron, and ferritin, and monitored their blood pressure.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 19-60 years old
- •Hemoglobin concentration less than 13g/dL(men), 12g/dL(women)
- •Able to give informed consent
排除标准
- •Allergic or hypersensitive to any of the ingredients in the test products
- •History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
- •Participation in any other clinical trials within past 2 months
- •History of alcohol or substance abuse
- •Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
- •Pregnant or lactating women etc.
研究组 & 干预措施
Placebo
干预措施: Placebo (Dietary Supplement)
Heme-Iron
干预措施: Heme-Iron (Dietary Supplement)
Organic Iron
干预措施: Organic Iron (Dietary Supplement)
Heme-Iron Polypeptide
干预措施: Heme-Iron Polypeptide (Dietary Supplement)
结局指标
主要结局
Changes in hemoglobin
时间窗: 4 weeks
Hemoglobin was measured in study visit 1(0 week) and visit 5(4 week).
Changes in transferrin saturation
时间窗: 4 weeks
Transferrin saturation was measured in study visit 1(0 week) and visit 5(4 week).
次要结局
- Changes in serum iron(4 weeks)
- Changes in ferritin(4 weeks)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital