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

July 8, 2024 updated by: Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University

The Impact of Predialytic Oral Protein-based Supplements on Nutritional Status and Quality of Life in Hemodialysis Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21526
        • Faculty of Medicine, Aexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control
50 patients will receive a routine nutrition regimen for 3 months. (control group)
Other: routine nutrition regimen
50 patients will receive a routine nutrition regimen for 3 months. (control group)
Experimental: 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
Dietary supplement: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effect on nutritional status
Time Frame: 3 months
assessment of nutritional status change at 3 months from baseline using Subjective Global Assessment (SGA)
3 months
effect on quality of life
Time Frame: 3 months
assessment of quality of life change at 3 months from baseline using the kidney disease quality of life 36 (KDQOL-36) short form
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effect on BMI
Time Frame: 3 months
BMI assessment change at 3 months from baseline
3 months
mid arm circumference and triceps skin fold
Time Frame: 3 months
Measurement of mid arm circumference and triceps skin fold change at 3 months from baseline
3 months
dialysis adequacy
Time Frame: 3 months
Estimation of Kt/V change at 3 months from baseline
3 months
effect on serum albumin
Time Frame: 3 months
measurement of serum albumin change at 3 months from baseline
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Study Chair: Mohamed Mamdouh Elsayed, MD, lecturer
  • Study Chair: Amr El Kazaz, MBBCh, Resident
  • Study Chair: Eman E EL Gohary, MD, PROFESSOR
  • Principal Investigator: Mohamed M Abdel Kader, MD, PROFESSOR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

June 15, 2024

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

July 2, 2023

First Submitted That Met QC Criteria

July 10, 2023

First Posted (Actual)

July 19, 2023

Study Record Updates

Last Update Posted (Actual)

July 9, 2024

Last Update Submitted That Met QC Criteria

July 8, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • oral protein in HD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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