the Regulation of Phosphorus Homeostasis by Dietary Phosphorus Intake in Normal Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Circadian rhythm of serum phosphorus concentration
研究概览
简要总结
The investigators have conducted the study about the effects of normal diet and low-phosphorus diet on phosphorus homeostasis in healthy subjects, now this study is designed to explore further about the effect of high-phosphorus diet on phosphorus homeostasis.
详细描述
Serum phosphate concentrations are not only associated with cardiovascular and all-cause mortality in chronic kidney disease (CKD) patients, but also associated with the mortality in community population. Thus, maintaining normal serum phosphate and reducing postprandial fluctuation of serum phosphate are essential for healthy people.
The investigators have conducted a study about the effects of normal diet (phosphorus 1500mg) and low-phosphorus diet (phosphorus 500mg) on phosphorus homeostasis in healthy men. The results showed low-phosphorus diet could significantly reduce serum phosphorus and urine phosphorus level compared to normal diet. However, the levels of serum FGF23 and a-klotho were not different between these two groups.Thus, the investigators want to further explore the effects of high-phosphorus diet (phosphorus 2300mg)on phosphorus homeostasis in healthy men.
Therefore, the investigators plan to conduct a crossover clinical study to evaluate the phosphorus homeostasis modulated by native normal diet, restricted phosphorus diet, high phosphorus diet and then to explore the underlying mechanisms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged 18-45 years
- •Healthy volunteers: no history of chronic diseases; no active symptoms or physical signs; negative results of electrocardiogram and chest X-ray; biochemical indicators of regular medical examination are within 95%-105% of normal range.
- •Willingness to sign the consent form approved by an Institutional Review Board and comply with the study protocol.
- •Body mass index ranged within 18.5-24 kg/m2.
排除标准
- •Current history of drug or alcohol abuse as assessed by the principal Investigator.
- •Subject has blood donations or blood loss more than 300ml within three months
- •Allergic to more than two foods or drugs.
- •Subject has psycho-disability or body disability.
- •Subject has a condition that in the judgment of the Principal Investigator could potentially pose a health risk to the patient while involved in the study.
- •Subject has participated in the other clinical trials at the same time.
研究组 & 干预措施
Normal Phosphorus Diet
Diet containing 1500mg of phosphorus per day
干预措施: normal diet (Other)
Low-phosphorus Diet
Diet containing 500mg of phosphorus per day
干预措施: low-phosphorus diet (Other)
High-phosphorus Die
Diet containing 2300mg of phosphorus per day
干预措施: high-phosphorus diet (Other)
结局指标
主要结局
Circadian rhythm of serum phosphorus concentration
时间窗: 24 hour
次要结局
- Circadian rhythm of urine phosphorus concentration(24 hour)
- Circadian rhythm of plasma fibroblast growth factor 23 (FGF23)(24 hour)
- Circadian rhythm of parathyroid hormone (PTH)(24 hour)
- Circadian rhythm of 1, 25-dihydroxyvitamin D (1,25(OH)2D3)(24 hour)