Effect of Different Timings of Protein Supplementation in Hemodialysis 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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-05-01

Brief Summary

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The aim of this work is to study the effect of different timings of protein supplementation on variable outcomes 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. PEW, showing a high prevalence (up to 50-75%) in patients with CKD stages 4-5, is closely associated with both increased morbidity/mortality risk and worsens quality of life.

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.

It is common for nephrologists to prescribe oral nutritional supplements (ONS), but the compliance to these at prescribed doses is relatively low. While directly administering ONS during hemodialysis (HD) ensures compliance and has been shown to improve nutritional status in these patients, the risks of intradialytic hypotension, inadequate dialysis, hygiene issues, and staff burden remain major deterrents for caregivers from formulating policies with regard to intradialytic meals.

Conditions

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Protein Supplementation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This research is a randomized multi-center clinical trial in which 120 hemodialysis patients will be randomly assigned to one of the study groups.

* Group A: 40 patients will receive oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) for 8 weeks 1 hour before the start of the session (pre-dialytic).
* Group B: 40 patients will receive oral protein nutritional supplement (ONS) for 8 weeks 2 hours after the start of the session (intra-dialytic).
* Group C: 40 patients will receive oral protein nutritional supplement (ONS) for 8 weeks in non-dialysis days (inter-dialytic).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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pre-dialytic

40 patients will receive oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) for 8 weeks 1 hour before the start of the session (pre-dialytic).

Group Type OTHER

oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session)

Intervention Type DIETARY_SUPPLEMENT

oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) given in group A (predialytic: 1 hour before the start of the session), in group B (intradialytic: 2 hours after the start of the session ), in group C (interdialytic: in non-dialysis days )

intra-dialytic

40 patients will receive oral protein nutritional supplement (ONS) for 8 weeks 2 hours after the start of the session (intra-dialytic).

Group Type OTHER

oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session)

Intervention Type DIETARY_SUPPLEMENT

oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) given in group A (predialytic: 1 hour before the start of the session), in group B (intradialytic: 2 hours after the start of the session ), in group C (interdialytic: in non-dialysis days )

inter-dialytic

40 patients will receive oral protein nutritional supplement (ONS) for 8 weeks in non-dialysis days (inter-dialytic).

Group Type OTHER

oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session)

Intervention Type DIETARY_SUPPLEMENT

oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) given in group A (predialytic: 1 hour before the start of the session), in group B (intradialytic: 2 hours after the start of the session ), in group C (interdialytic: in non-dialysis days )

Interventions

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oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session)

oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) given in group A (predialytic: 1 hour before the start of the session), in group B (intradialytic: 2 hours after the start of the session ), in group C (interdialytic: in non-dialysis days )

Intervention Type DIETARY_SUPPLEMENT

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.
* Significant edema and fluid overload.
* Hepatic patients.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No