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.
Full Title of Study: “The Impact of a Nutritional Intervention Based on Egg White for Phosphorus Control in Haemodialysis Patients”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: November 2017
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.
- Other: Egg White replacement
- Nutritional intervention: the meat or fish of two meals will be replaced twice a week with an equivalent amount (in protein content) of egg white.
Arms, Groups and Cohorts
- No Intervention: Control
- usual diet
- Experimental: Intervention
- egg white instead of meat or fish in two meals twice a week for three months
Clinical Trial Outcome Measures
- Decrease in serum phosphate levels
- Time Frame: 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
- Changes in body composition assessed by bioelectrical impedance analysis
- Time Frame: BIA will be performed monthly for three months from the beginning of the study
- Protein malnutrition causes a decrease in body cell mass. By bioelectrical impedance analysis (BIA) the changes in this parameter in the two experimental groups will be evaluated at one, two and three months from the beginning of the study.
- Changes in serum albumin concentration
- Time Frame: Serum albumin will be measured monthly for three months from the beginning of the study
- Protein malnutrition causes a decrease in serum albumin concentration that will be, therefore, monitored, at one, two and three months from the beginning of the study.
- Changes in hemoglobin levels
- Time Frame: hemoglobin level will be measured monthly for three months from the beginning of the study
- Protein malnutrition causes a decrease in hemoglobin levels that will be, therefore, monitored, at one, two and three months from the beginning of the study.
Participating in This Clinical Trial
- 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 Exclusion Criteria:
- diabetes – liver disease – malignancy – previous parathyroidectomy – psychiatric diseases – non-collaborative patients
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Federico II University
- Provider of Information About this Clinical Study
- Principal Investigator: Bruna Guida, Associate Professor in Physiology – Federico II University
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