Comparison of the Effects of Different Protein Diet in Hemodialysis Patients

NCT ID: NCT04077918

Last Updated: 2019-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diffenence of Protein Diets on Hemodialysis Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

protein diet

Intervention Type DIETARY_SUPPLEMENT

100 CHD patients will be recruited and randomized into 2 groups with an additional animal or plant protein 18g per day

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

Group Type ACTIVE_COMPARATOR

protein diet

Intervention Type DIETARY_SUPPLEMENT

100 CHD patients will be recruited and randomized into 2 groups with an additional animal or plant protein 18g per day

Interventions

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protein diet

100 CHD patients will be recruited and randomized into 2 groups with an additional animal or plant protein 18g per day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Camillians Saint Mary's Hospital Luodong

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shih-Ching Tsai, MD

Role: PRINCIPAL_INVESTIGATOR

St. Mary's Hospital Luodong

Central Contacts

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Shih-Ching Tsai, MD

Role: CONTACT

+88639544106 ext. 7951

Yu-Ming Chang, MD

Role: CONTACT

+88639544106 ext. 7952

Other Identifiers

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SMHprotdiet

Identifier Type: -

Identifier Source: org_study_id

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