Testing a Natural Polyphenol Supplement to Inhibit Dietary Iron Absorption in Thai Adults with Iron-loading Thalassemia: a Stable Isotope Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Difference in fractional iron absorption (FIA) from iron-rich test meal administered with and without the polyphenol supplement (PPS).
研究概览
简要总结
Genetic disorders, such as thalassemia, can lead to iron overload and severe adverse health outcomes. In iron-loading thalassemia, iron overload is due to increased iron absorption. Iron accumulates in the body organs causing widespread damage. The standard treatment is iron chelation therapy and/or periodic phlebotomy to remove iron from the body; frequency of phlebotomy or chelation therapy is dependent on how quickly body iron stores accumulate.
Polyphenolic compounds are very strong inhibitors of non-heme iron absorption, as they form insoluble complexes with ferrous iron in the gastrointestinal tract that cannot be absorbed.
The investigators have recently shown in European subjects with hereditary hemochromatosis (another iron-loading disorder) that our newly-developed natural polyphenol supplement (PPS) that is rich in polyphenols, when taken with iron-rich meals or with an iron-fortified drink, reduces iron absorption by ~40%. Decreasing non-heme iron absorption in adults with iron-loading thalassemia could potentially lead to an extension of the time period between phlebotomies or chelation therapies, and therefore an improved quality of life.
Therefore, in this stable iron isotope study, the investigators will study the effect the natural PPS on oral iron absorption from an iron-rich test meal or iron-fortified drink in Thai adults with iron-loading thalassemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Documented diagnosis of thalassemia minor or intermedia (β-thalassemia with or without α-globin gene mutations, Hb E/β-thalassemia with or without α-globin gene mutations, or α-thalassemia Hb H disease) based on Hb electrophoresis/HPLC and/or DNA analysis from the subject's medical record.
- •Hemoglobin (Hb): 7.0-13.5 g/dL for males; 7.0-12.0 for females
- •Serum ferritin (SF): 300-800 ug/L for males; 200-800 ug/L for females
- •Not having had a blood transfusion within 6 months prior to the study start
- •Age 18-49 y, not pregnant or lactating
- •Body weight <75 kg and body mass index (BMI) between 17 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 or blood transfusion during the study period
- •The last phlebotomy will be at least 4 weeks prior to first study visit
- •No intake of iron chelators 4 weeks prior to first study visit and throughout the study period
- •No use of medications affecting iron absorption or metabolism during the study
- •No intake of mineral/vitamin supplements 2 weeks prior to the first study visit and during the study
- •No participation in any other clinical study within the last 30 days and during the study
- •Expected to comply with study protocol
排除标准
- 未提供
研究组 & 干预措施
Meal with polyphenol supplement (PPS)
Iron-rich test meal labelled with stable iron isotope as ferrous sulfate, consumed with the polyphenol supplement.
干预措施: Meal matrix with polyphenol supplement (PPS) (Dietary Supplement)
Meal with placebo
Iron-rich test meal labelled with stable iron isotope as ferrous sulfate, consumed with placebo supplement (maltodextrin).
干预措施: Meal matrix with placebo (Dietary Supplement)
Drink with PPS
Iron-fortified drink labelled with stable iron isotope as ferrous sulfate, consumed with the polyphenol supplement.
干预措施: No meal matrix with PPS (Dietary Supplement)
Drink with placebo
Iron-fortified drink labelled with stable iron isotope as ferrous sulfate, consumed with placebo supplement (maltodextrin).
干预措施: No meal matrix with placebo (Dietary Supplement)
结局指标
主要结局
Difference in fractional iron absorption (FIA) from iron-rich test meal administered with and without the polyphenol supplement (PPS).
时间窗: Measured 14 days after administration of last test meal (study day 18 or 35)
FIA from labelled test meals consumed with the PPS and consumed with the placebo will be determined based on the shift of the iron isotope ratios in whole blood.
Difference in FIA from iron-fortified test drink administered with and without the PPS.
时间窗: Measured 14 days after administration of last test drink (study day 18 or 35)
FIA from labelled test drink consumed with the PPS and consumed with the placebo will be determined based on the shift of the iron isotope ratios in whole blood.
次要结局
- Soluble transferrin receptor (mg/L)(At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35))
- Transferrin saturation (%)(At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35))
- Serum ferritin (µg/L)(At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35))
- Hemoglobin (g/dL)(At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35))
- C-reactive protein (mg/L)(At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35))
- Alpha-1-glycoprotein (g/L),(At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35))
- Serum hepcidin (nM)(At baseline (study day 1), midpoint (study day 18), and endpoint (study day 35))