Comparison of the Effects of Different Protein Diet in Hemodialysis Patients

Diffenence of Protein Diets on Hemodialysis Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04077918
• Other study ID #: SMHprotdiet
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: September 2019
• Source: Camillians Saint Mary's Hospital Luodong
• Contact: Shih-Ching Tsai, MD
• Phone: +88639544106
• Email: uftsai.tseng[@]msa.hinet.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diffenence of Protein Diets on Hemodialysis Patients

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Camillians Saint Mary's Hospital Luodong

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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