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
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2019
CompletedFirst Posted
Study publicly available on registry
September 4, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedSeptember 6, 2019
September 1, 2019
7 months
August 24, 2019
September 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Statistical difference of medical visits
7 months
Other Outcomes (1)
Statistical difference of admissions
7 months
Study Arms (2)
Plant protein diet
ACTIVE COMPARATOR18 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
ACTIVE COMPARATOR18 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
Interventions
100 CHD patients will be recruited and randomized into 2 groups with an additional animal or plant protein 18g per day
Eligibility Criteria
You may qualify if:
- Chronic hemodialysis patient
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Shih-Ching Tsai, MD
St. Mary's Hospital Luodong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2019
First Posted
September 4, 2019
Study Start
October 1, 2019
Primary Completion
April 30, 2020
Study Completion
April 30, 2020
Last Updated
September 6, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share