Comparison of the Effects of Different Protein Diet in Hemodialysis Patients

Study Overview
=================
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.

Official Title
-----------------
Comparison of the Effects of Animal Protein Diet and Plant Protein Diet on Blood Test Result and Clinical Outcome in Hemodialysis Patients

Conditions
-----------------
Diffenence of Protein Diets on Hemodialysis Patients

Intervention / Treatment
-----------------
* Dietary Supplement: protein diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic hemodialysis patient Exclusion Criteria: Hemodialysis less than 3 months Age < 20 years or >90 years Serum albumin < 3 g/dL， Daily protein diet < 0.6 gm/kg/day or > 1.2 gm/kg/ day， Cannot obey the diet plan: Gastrectomy, difficult in swallowing Active infection, severe illness: cancer patient, liver cirrhosis, etc. Unable to cooperate in the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plant protein diet<br>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 | Dietary Supplement: protein diet<br>* 100 CHD patients will be recruited and randomized into 2 groups with an additional animal or plant protein 18g per day<br>|
| Active Comparator: Animal protein diet<br>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 | Dietary Supplement: protein diet<br>* 100 CHD patients will be recruited and randomized into 2 groups with an additional animal or plant protein 18g per day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statistical difference of serum biomarkers ( P value) | 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. | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statistical difference of medical visits | 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. | 7 months |