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临床试验/NCT04845724
NCT04845724已完成不适用

The Effect of Dietary Phosphorus Load and Food Matrix on Postprandial Serum Phosphate in Hemodialysis Patients

University College Cork0 个研究点目标入组 8 人开始时间: 2016年11月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
主要终点
Serum Phosphate

研究概览

简要总结

This study is to investigate the acute postprandial effect of a modified versus standard low phosphorus diet on serum phosphate, potassium and intact parathyroid levels in prevalent hemodialysis (HD) patients

详细描述

Background: Potential dietary strategies for controlling hyperphosphataemia include the use of protein sources with lower phosphorus bioavailability such as pulses and nuts, focus on phosphorus to protein ratios and the avoidance of all phosphate additives.

Method: Controlled crossover feeding study in 8 HD patients. On one day, participants were directly observed eating a standard low phosphorous diet and on the other day, a modified low phosphorus diet. The modified diet included beef and less dairy, with a lower phosphorus to protein ratio, as well as plant-based protein, whole grains, pulses and nuts containing phytates which reduces phosphorus bioavailability. Both diets were tailored for each participant to provide 1.1g protein/kg ideal body weight. Participants provided fasting bloods before breakfast, a pre-prandial sample before lunch and samples at one hour intervals for the four hours after the meal, for analysis of phosphate, potassium and intact parathyroid hormone (iPTH).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

盲法说明

Catering staff, who were blinded to the identity of the participants, provided meals in random order. Participants were blinded to the initial meal selection until the day of the study.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •> 18 years of age;
  • •on dialysis for > 3 months;
  • •pre-dialysis serum phosphate < 2.5 mmol/L and
  • •serum potassium < 6.3 mmol/L on most recent routine monthly blood test;
  • •urinary outputs of < 200 ml/day by self-report;
  • •being in their usual state of health

排除标准

  • •history of diabetes mellitus
  • •history of parathyroidectomy
  • •history of calciphylaxis

研究组 & 干预措施

Standard Diet

Active Comparator

The standard diet was based on the current dialysis diet sheet. The standard diet main meal contained a higher proportion of foods with a higher phosphorus to protein ratio (salmon and dairy), and foods with higher phosphorus bioavailability (cake). The diet was tailored for each participant to provide 1.1g protein/kg ideal body weight. The major differences between the diets were at the main meal.

干预措施: Standard Diet (Other)

Modified Diet

Experimental

The modified diet, representative of the proposed modified phosphorus diet used food of lower phosphorus to protein ratio such as beef and less dairy. Approximately 30% dietary phosphorus in the modified diet came from foods with significant phytate content such as pulses, nuts and whole grains. The modified diet was tailored for each participant to provide 1.1g protein/kg ideal body weight.

干预措施: Modified Diet (Other)

结局指标

主要结局

Serum Phosphate

时间窗: Post -prandial period (4 hours)

mmol/l

次要结局

  • Serum Potassium(Post -prandial period (4 hours))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph Eustace

Professor Joseph Eustace

University College Cork

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