Diffenence of Protein Diets on Hemodialysis Patients
Conditions
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.
Interventions
DIETARY_SUPPLEMENTprotein diet
100 CHD patients will be recruited and randomized into 2 groups with an additional animal or plant protein 18g per day
Sponsors
Camillians Saint Mary's Hospital Luodong
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Statistical difference of admissions | 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. |
Contacts
Primary ContactShih-Ching Tsai, MD
Backup ContactYu-Ming Chang, MD
Outcome results
None listed