Comparison of the Effects of Different Protein Diet in Hemodialysis Patients
September 4, 2019 updated by: Camillians Saint Mary's Hospital Luodong
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
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
|
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
|
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)
Time Frame: 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.
|
7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Statistical difference of medical visits
Time Frame: 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.
|
7 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Statistical difference of admissions
Time Frame: 7 months
|
. 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
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shih-Ching Tsai, MD, St. Mary's Hospital Luodong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.