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

Alexandria University

Status: Completed

Conditions: Hemodialysis Complication

Treatments: Dietary Supplement: oral protein nutritional supplement (Fresubin protein powder); Other: routine nutrition regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT05952570

oral protein in HD

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

protein supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: oral protein nutritional supplement (Fresubin protein powder)

control

Placebo Comparator group

Description:

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

Treatment:

Other: routine nutrition regimen