the Effects of Different Dietary Phosphorus Intake on the Circadian Pattern of Serum Phosphate in Normal Subjects
研究概览
详细说明
Emerging evidence show that 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 (without history of CKD or cardiovascular disease). The rise of serum phosphate will lead to the elevation of serum plasma fibroblast growth factor 23 (FGF23) and parathyroid hormone (PTH) in healthy people, contributing to bone disorders and left ventricle thickening. Therefore, maintaining normal serum phosphate and reducing postprandial fluctuation of serum phosphate are essential for CKD patients as well as healthy people.
As for serum phosphate modulation by diet, most evidence was focused on CKD patients, less focused on healthy people. An American study in 1980s indicated that phosphorus intake was significantly related with the level of 24-h serum phosphate and the circadian pattern of serum phosphate. However, this study failed to explore the underlying mechanisms and the diet in America is different from that in China. Nowadays, normal diet in China is inclined to having more calories and protein, which warrants high diet phosphorus intake, may contributing to huge fluctuation of serum phosphate and thus elevating the incidence and mortality of cardiovascular disease. Therefore, what is the level and circadian pattern of serum phosphate concentrations in normal subjects under our native normal diet in China? Is restricted phosphate diet able to alter the level and circadian pattern of serum phosphate? These questions are what the investigator sare eager to answer.
Accumulating evidence suggest that gastrointestinal tract has a vital effect in phosphate modulation. Berndt etc. suggested that in rat, epidermal cells of duodenum and jejunum could sense the gastrointestinal tract phosphate load, rapidly activating the type IIa Na/Pi-cotransporter in the renal tubule cells, leading to the increase of urinary phosphate, without any changes of serum FGF23, PTH and phosphate concentrations. So the author proposed that there had a gastro intestine-kidney axis in phosphate modulation. However, whether this axis exists in human body remains unclear.
Therefore, the investigators plan to conduct a crossover clinical study to evaluate the level and circadian pattern of serum phosphate concentrations modulated by native normal diet and restricted phosphate diet and then to explore the underlying mechanisms.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Shanghai
-
Shanghai、Shanghai、中国、200040
- Huashan hospital, Shanghai Medical College, Fudan University
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 分配:非随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:正常磷饮食
每天含磷 1500 毫克的饮食
|
含磷 1500mg 的饮食
|
实验性的:Restricted Phosphorus Diet
Diet containing 500mg of phosphorus per day
|
Diet containing 500mg of phosphorus
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
血清磷浓度的昼夜节律
大体时间:24小时
|
24小时
|
次要结果测量
结果测量 |
大体时间 |
---|---|
血浆成纤维细胞生长因子 23 (FGF23) 的昼夜节律
大体时间:24小时
|
24小时
|
甲状旁腺激素 (PTH) 的昼夜节律
大体时间:24小时
|
24小时
|
1, 25-二羟基维生素 D (1,25(OH)2D3) 的昼夜节律
大体时间:24小时
|
24小时
|
Circadian rhythm of matrix extracellular phosphoglycoprotein (MEPE)
大体时间:24 hour
|
24 hour
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- HuashanH
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
正常饮食的临床试验
-
Rush University Medical CenterUniversity of Chicago; National Institute on Aging (NIA); Advocate Hospital System招聘中
-
University of CalgaryStewart Diabetes Education Fund完全的