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Completed

NCT Number: NCT05952570

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Aexandria University

Alexandria, 21526, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral protein nutritional supplement (Fresubin protein powder)

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

routine nutrition regimen

Other

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

Primary outcomes

  1. effect on nutritional status

    Time frame: 3 months

    assessment of nutritional status change at 3 months from baseline using Subjective Global Assessment (SGA)

  2. 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

Secondary outcomes

  1. effect on BMI

    Time frame: 3 months

    BMI assessment change at 3 months from baseline

  2. 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. dialysis adequacy

    Time frame: 3 months

    Estimation of Kt/V change at 3 months from baseline

  4. effect on serum albumin

    Time frame: 3 months

    measurement of serum albumin change at 3 months from baseline

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2023
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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