Testing the Efficacy of a Natural Polyphenol Supplement to Inhibit Dietary Iron Absorption in Subjects With Hereditary Hemochromatosis: a Stable Isotope Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- change from baseline in the isotopic ratio of iron in blood at week 4
研究概览
简要总结
Polyphenolic compounds are very strong Inhibitors of non-heme iron absorption, as they form insoluble complexes with ferrous iron. Patients with hereditary hemochromatosis (HH) have an increased intestinal non-heme iron absorption due to a genetic mutation in the regulatory pathway, leading to excess iron in the body. This study investigates the inhibitory effect of a natural polyphenol Supplement in participants with HH.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Homozygous for C282Y mutation in HFE (hemochromatosis) gene
- •Written informed consent
- •Age 18-65 y
- •Not pregnant or lactating
- •Body weight < 75 kg
- •Body mass index (BMI) between 18.5 and 25 kg/m2
- •No acute illness/infection (self-reported)
- •No metabolic or gastrointestinal disorders, eating disorders or food allergy to the ingredients of the test meal (self-reported)
- •No scheduled phlebotomy throughout the study period
- •The last phlebotomy will be at least 4 weeks prior first test meal administration
- •No use of medications affecting iron absorption or metabolism during the study
- •No intake of mineral/vitamin supplements 2 weeks before the first study day and during the study
- •Participation in any other clinical study within the last 30 days
- •Expected to comply with study protocol
排除标准
- 未提供
结局指标
主要结局
change from baseline 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 administration of a test meal/drink including iron isotopes
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 administration of a test meal/drink including iron isotopes
次要结局
- Serum Hepcidin (nM)(baseline, and weeks 2)
- Hemoglobin (g/dL)(baseline, weeks 2, and 4)
- Serum Ferritin concentration (µg/L)(baseline, weeks 2, and 4)
- Serum iron concentration (µg/dL)(baseline, weeks 2, and 4)
- Soluble transferrin receptor (mg/L)(baseline, weeks 2, and 4)
- Transferrin saturation in %(baseline, weeks 2, and 4)
- C-reactive Protein (mg/L)(baseline, weeks 2, and 4)
- alpha-1-glycoprotein (g/L)(baseline, weeks 2, and 4)
研究者
Prof. Michael B. Zimmermann
Head of the Laboratory of Human Nutrition
Swiss Federal Institute of Technology