Comparison of the Effects of Different Protein Diet in Hemodialysis Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Diffenence of Protein Diets on Hemodialysis Patients
• Intervention / Treatment: Dietary supplement: protein diet

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shih-Ching Tsai, MD; Phone Number: 7951 +88639544106; Email: uftsai.tseng@msa.hinet.net
• Study Contact Backup: Name: Yu-Ming Chang, MD; Phone Number: 7952 +88639544106; Email: ynk123.tw@yahoo.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Plant 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	Dietary supplement: protein diet; 100 CHD patients will be recruited and randomized into 2 groups with an additional animal or plant protein 18g per day
Active Comparator: Animal 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	Dietary supplement: protein diet; 100 CHD patients will be recruited and randomized into 2 groups with an additional animal or plant protein 18g per day

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Statistical difference of admissions	. We will also review the patient's admission record to see what's the diagnosis and what's the number of admission during the study period.	7 months

Collaborators and Investigators

• Sponsor: Camillians Saint Mary's Hospital Luodong
• Investigators: Principal Investigator: Shih-Ching Tsai, MD, St. Mary's Hospital Luodong

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): April 30, 2020

Study Registration Dates

• First Submitted: August 24, 2019
• First Submitted That Met QC Criteria: September 1, 2019
• First Posted (Actual): September 4, 2019

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 4, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: SMHprotdiet

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No