The Impact of a Nutritional Intervention Based on Egg White for Phosphorus Control in Haemodialysis Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Decrease in serum phosphate levels
研究概览
简要总结
To evaluate the effect on phosphatemia in hemodialysis patients of replacing the meat or fish included in two meals a week with an amount of egg white containing the same quantity of proteins.
详细描述
Hyperphosphatemia develops in the majority of patients with end-stage renal disease (ESRD). It is responsible for severe complications such as mineral bone disease, and has a role in worsening the cardiovascular mortality of dialyzed patients. Therefore, a close control of serum phosphorus remains a cornerstone in the clinical management of dialyzed patients to improve their long term prognosis. There are multiple sources of phosphorus in the diet that could be the target of such a dietary intervention but, because of important differences in bioavailability, they are not all equally relevant in influencing phosphatemia. Among them animal proteins that have a bioavailability of about 60% represent an important target for phosphate-lowering nutritional interventions. However, lowering the protein content of the diet in hemodialysis (HD) patients may be dangerous because it may increase the the risk of malnutrition hence worsening their prognosis. In the present study we intend to explore an alternative strategy to lower the intake of phosphate with animal proteins by replacing the meat or fish included in two meals a week with egg white that is reach of proteins but has virtually no phosphate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •thrice weekly 4 h standard bicarbonate HD treatment with an at least 6-month vintage
- •stable dialysis dose and modality at least by 3 months
- •hyperphosphataemia (serum phosphate ≥5.0 mg/dl) at least by 3 months
- •stable dietary intake at least by 3 months
- •stable body weight at least by 3 months
- •stable biochemical markers at least by 3 months
排除标准
- •liver disease
- •malignancy
- •previous parathyroidectomy
- •psychiatric diseases
- •non-collaborative patients
研究组 & 干预措施
Control
usual diet
Intervention
egg white instead of meat or fish in two meals twice a week for three months
干预措施: Egg White replacement (Other)
结局指标
主要结局
Decrease in serum phosphate levels
时间窗: Phosphate level will be measured monthly for three months from the beginning of the study
This is the primary outcome because of the link between cardiovascular mortality and hyperphosphatemia
次要结局
- Changes in body composition assessed by bioelectrical impedance analysis(BIA will be performed monthly for three months from the beginning of the study)
- Changes in serum albumin concentration(Serum albumin will be measured monthly for three months from the beginning of the study)
- Changes in hemoglobin levels(hemoglobin level will be measured monthly for three months from the beginning of the study)
研究者
Bruna Guida
Associate Professor in Physiology
Federico II University
