Impact of Predialytic Oral Protein on Nutritional Status and Quality of Life in HD Patients

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

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-07-01

Brief Summary

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The aim of this work is to study the effects of oral protein-based supplements on nutritional status in hemodialysis patients

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Detailed Description

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Chronic kidney disease (CKD) is a prevalent chronic condition and the incidence of end-stage renal disease (ESRD) is expected to increase over the next few decades. In patients with CKD, especially in those with ESRD and undergoing maintenance dialysis therapy (MDT), a state of metabolic and nutritional derangements, more aptly called protein-energy wasting (PEW), caused by a combination of insufficient intake, uremic toxins, inflammation, and superimposed catabolism, plays a major role among the many risk factors that affect outcomes of CKD .

Oral nutritional supplement (ONS) is a simple and effective way to supplement energy and protein to malnourished patients on the basis of regular diet. Therefore, if the protein of regular diet in dialysis patients are not enough, they should be supplemented with (ONS) when appropriate.

Conditions

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Hemodialysis Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This research is a randomized multi-center clinical trial in which 100 hemodialysis patients will be randomly assigned to one of the study groups using block randomization with a ratio of 1:1.

* Group A: 50 patients will receive oral protein nutritional supplement (Fresubin protein powder 25mg/5scoops per hemodialysis session) 1 hour before the start of the session (predialytic) for 3 months.
* Group B: 50 patients will receive a routine nutrition regimen for 3 months. (control group)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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protein supplement

50 patients will receive oral protein nutritional supplement (Fresubin protein powder 25mg/5scoops per hemodialysis session) 1 hour before the start of the session (predialytic) for 3 months

Group Type EXPERIMENTAL

oral protein nutritional supplement (Fresubin protein powder)

Intervention Type DIETARY_SUPPLEMENT

50 patients will receive oral protein nutritional supplement (Fresubin protein powder 25mg/5scoops per hemodialysis session) 1 hour before the start of the session (predialytic) for 3 months

control

50 patients will receive a routine nutrition regimen for 3 months. (control group)

Group Type PLACEBO_COMPARATOR

routine nutrition regimen

Intervention Type OTHER

50 patients will receive a routine nutrition regimen for 3 months. (control group)

Interventions

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oral protein nutritional supplement (Fresubin protein powder)

50 patients will receive oral protein nutritional supplement (Fresubin protein powder 25mg/5scoops per hemodialysis session) 1 hour before the start of the session (predialytic) for 3 months

Intervention Type DIETARY_SUPPLEMENT

routine nutrition regimen

50 patients will receive a routine nutrition regimen for 3 months. (control group)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult hemodialysis patients (≥18 years of age).
* Received dialysis for at least 6 months prior to study screening.
* Receive hemodialysis at least 3 times per week .

Exclusion Criteria

* Receiving nutritional supplementation prior to study commencing or within 1 month of commencement in the study .
* Participants with an allergy to any ingredients in the nutritional supplements.
* Persistent hyperkalemia or hyperphosphatemia (defined as the last 3 months).
* Significant edema and fluid overload.
* Hepatic patients

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No