Comparison of the Effects of Different Protein Diet in Hemodialysis Patients

Not Applicable

• Conditions: Diffenence of Protein Diets on Hemodialysis Patients
• Interventions: Dietary Supplement: protein diet

• Registration Number: NCT04077918
• Lead Sponsor: Camillians Saint Mary's Hospital Luodong

Brief Summary

Chronic hemodialysis (CHD) patients are vulnerable to develop protein energy malnutrition and make a notion that to maintain the nutritional status is of paramount importance in these patients. However, proteins intake from vegetarian and meat diet were observed to have different impacts on nutritional and inflammatory status, mineral homeostasis and its related hormones, and clinical outcomes in non-dialysis CKD patients. In here, we aim to investigate these impacts in CHD patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-24
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-01
• Study First Posted: 2019-09-04
• Last Update Submitted: 2019-09-04
• Last Update Posted: 2019-09-06
• Study Start: 2019-10-01
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Chronic hemodialysis patient

Exclusion Criteria

1. Hemodialysis less than 3 months
2. Age < 20 years or >90 years
3. Serum albumin < 3 g/dL，
4. Daily protein diet < 0.6 gm/kg/day or > 1.2 gm/kg/ day，
5. Cannot obey the diet plan: Gastrectomy, difficult in swallowing
6. Active infection, severe illness: cancer patient, liver cirrhosis, etc.
7. Unable to cooperate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Plant protein diet	protein diet	18 g of plant protein diet added every day for 3 months , and after washout for 1 month, 18 g of animal protein diet added every day for 3 months
Animal protein diet	protein diet	18 g of animal protein diet added every day for 3 months, and after washout for 1 month, 18 g of plant protein diet added every day for 3 months

Primary Outcome Measures

Name	Time	Method
Statistical difference of serum biomarkers ( P value)	7 months	The items scheduled to be evaluated in this study include serum albumin, pre-albumin, phosphate, calcium, magnesium, lipid profile, ferritin, transferrin, hs-CRP, Alk-P, iPTH, 25(OH)D3, intact \& C-terminal FGF23, Klotho and hepcidin levels. We'll collect the patient's serum data in plant diet group, and collect the serum data in animal diet group, then we'll compare the data in these two groups to see whether there is any difference between each item.

Secondary Outcome Measures

Name	Time	Method
Statistical difference of medical visits	7 months	We'll review the patient's medical record in outpatient department . We'll look at what's the diagnosis and what's the number of the medical visits during the study period.