Effect of Different Timings of Protein Supplementation in Hemodialysis Patients

Alexandria University

Status: Completed

Conditions: Protein Supplementation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05953636

Timing of protein in HD

Details and patient eligibility

About

The aim of this work is to study the effect of different timings of protein supplementation on variable outcomes 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. 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.

Enrollment: 120 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.
• 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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120 participants in 3 patient groups

pre-dialytic

Other group

Description:

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).

Treatment:

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

intra-dialytic

Other group

Description:

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

Treatment:

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

inter-dialytic

Other group

Description:

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

Treatment:

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