AzTrials
AzTrials

End Stage Renal Disease on DialysisNCT04546958

Nutritional Interventions in Peritoneal Dialysis Patients with Hypoalbuminemia

A study testing Whey protein supplements and Nutritional counseling in people with End Stage Renal Disease on Dialysis, run by Far Eastern Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Inadequate dietary protein intake is well-known cause of hypoalbuminemia in dialysis population. Protein loss into dialysate and increased catabolic state due to uremic milieu or inflammation worsened hypoalbuminemia, hence high protein diet is recommended in patients on peritoneal dialysis (PD). Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
End Stage Renal Disease on Dialysis
What is being tested?
Whey protein supplements and Nutritional counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteTaiwan
Study dates
2 Oct 2020to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged greater than or equal to 20 years
  • Having end-stage kidney disease and having undergone maintenance PD for more than three months
  • Having adequate dialysis (weekly Kt/V greater than or equal to 1.7)
  • Serum albumin levels lower than 4.0 g/dL, measured by bromocresol green assay

Who cannot join

  • Untreated fluid overload
  • Uncorrected metabolic acidosis
  • Having active infection or inflammation
  • Hospitalization within the past 4 weeks
  • Having gastrointestinal bleeding
  • those who cannot cooperate with the dietary record
Show all 9Show fewer
  • those who have poor adherence to whey protein consumption
  • History of psychiatric disorders
  • Having mental retardation

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Far Eastern Memorial Hospital

    New Taipei City

Other trials in Taiwan

About this study

Official title: Clinical Implication of Nutritional Counseling and Whey Protein Supplements in Patients on Peritoneal Dialysis with Hypoalbuminemia

Inadequate dietary protein intake is well-known cause of hypoalbuminemia in dialysis population. Protein loss into dialysate and increased catabolic state due to uremic milieu or inflammation worsened hypoalbuminemia, hence high protein diet is recommended in patients on peritoneal dialysis (PD). The recommendations from K/DOQI clinical practice guidelines for the amount of daily protein intake is based on expert opinion and the optimal daily protein intake in PD patients is not known. The investigators hypothesize that higher dietary protein intake has a greater beneficial effect on nutritional status in hypoalbuminemic PD patients. In particular, 1.5 g/kg protein intake provides a better beneficial effect than 1.2 g/kg protein intake.

Read the detailed description

Hypoalbuminemia is common and is strongly associated with an increased risk for mortality in patients with end-stage kidney disease (ESKD). Inadequate dietary protein intake is well-known cause of hypoalbuminemia in dialysis population. Protein loss into dialysate and increased catabolic state due to uremic milieu or inflammation worsened hypoalbuminemia, hence high protein diet is recommended in PD patients. Although there is an increased daily calorie intake from absorption of dialysate glucose concentration, hypoalbuminemia ensues in a substantial number of PD patients. There is concern that a disproportionately increasing calorie intake from dialysate glucose with no change in dietary protein intake causes weight gain which in turn worsens sarcopenic obesity in PD patients. Achieving adequate dietary protein intake should be the priority in the management of hypoalbuminemia. It is feasible for PD patients to increase dietary protein intake through protein supplements. Among nutritional supplements, whey protein has several positive effects on carbohydrate metabolism, muscle building, immune function, and human health in various areas of disease, supported by well-performed studies. There are limited data available regarding the effects of nutritional counseling and whey protein supplements on the nutritional, body compositional status and immune function of PD patients with hypoalbuminemia. The recommendations from K/DOQI clinical practice guidelines for the amount of daily protein intake is based on expert opinion and the optimal daily protein intake in PD patients is not known.

The aims of the study are to investigate the optimal dietary protein intake and to examine the effects of whey protein supplement on the change of nutritional, body composition and immune function in PD patients with hypoalbuminemia. Specifically, the investigators will compare the effect of nutritional counseling (1.2 g/kg protein intake) with that of nutritional counseling and whey protein supplement (1.5 g/kg protein intake) regarding the changes of nutritional, body composition parameters and immune function in PD patients. This is a quality improvement program to cope with the fact that the proportion of hypoalbuminemic PD patients sometimes does not meet the requirements set by Joint Commission of Taiwan, and to improve the nutritional status of PD patients in a feasible way of daily clinical practice.

The investigators are going to conduct a randomized, controlled trial with cross-over design. Subjects with ESKD undergoing maintenance PD for more than three months, adequate dialysis, and hypoalbuminemia will be recruited. Those with non-dietary cause of hypoalbuminemia including untreated fluid overload, uncorrected metabolic acidosis, having active infection or inflammation, hospitalization within the past 4 weeks, having gastrointestinal bleeding, those who cannot cooperate with the dietary record, those who have poor adherence to whey protein consumption, history of psychiatric disorders and having mental retardation will be excluded. Participants will receive nutritional counseling with whey protein supplement or nutritional counseling alone for 3-month period, separated by 3-month washout period. The study outcome measures are difference in change-from-baseline nutritional, body composition parameters and immune function between the two study periods.

Being tested
Whey protein supplements, Nutritional counseling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whey protein supplementsDietary supplement

    Nutritional counseling and whey protein supplements for 3 months

  • Nutritional counselingOther

    Nutritional counseling by dietitians for 3 months

Study groups in NCT04546958
Study groupRoleWhat they receive
Nutritional counseling armActive comparatorNutritional counseling, targeting daily protein intake 1.2 g/kg Dietitian will provide one-to-one dietary education, 30 minutes duration, on a monthly basis
Receives: Other: Nutritional counseling
Nutritional counseling plus whey protein supplements armExperimentalNutritional counseling plus whey protein supplements, targeting daily protein intake 1.5 g/kg In addition to receiving nutritional counseling, participants are instructed to take an additional whey protein supplement at the dose of ~0.3 g/kg protein intake.
Receives: Dietary Supplement: Whey protein supplements; Other: Nutritional counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Concentrations of albumin (g/dL)

    Difference in change-from-baseline albumin (g/dL) between two intervention arms

    Measured: 3 months

Secondary outcomes (19)
  1. Concentrations of pre-albumin (g/dL)

    Difference in change-from-baseline pre-albumin (g/dL) between two intervention arms

    Measured: 3 months

  2. Concentrations of C-reactive protein (mg/dL)

    Difference in change-from-baseline C-reactive protein (mg/dL) between two intervention arms

    Measured: 3 months

  3. Concentrations of phosphate (mg/dL)

    Difference in change-from-baseline phosphate (mg/dL) between two intervention arms

    Measured: 3 months

  4. Concentrations of blood urea nitrogen (mg/dL)

    Difference in change-from-baseline blood urea nitrogen (mg/dL) between two intervention arms

    Measured: 3 months

  5. Concentrations of free indoxyl sulfate (mg/L)

    Difference in change-from-baseline free indoxyl sulfate (mg/L) between two intervention arms

    Measured: 3 months

  6. Concentrations of free p-cresol sulfate (mg/L)

    Difference in change-from-baseline free p-cresol sulfate (mg/L) between two intervention arms

    Measured: 3 months

  7. Absolute number (per μl blood) of CD4+ (cluster of differentiation 4) T cells

    Difference in change-from-baseline absolute number (per μl blood) of CD4+ T cells between two intervention arms

    Measured: 3 months

  8. Absolute number (per μl blood) of CD8+ (cluster of differentiation 8) T cells

    Difference in change-from-baseline absolute number (per μl blood) of CD8+ T cells between two intervention arms

    Measured: 3 months

  9. Absolute number (per μl blood) of monocytes

    Difference in change-from-baseline absolute number (per μl blood) of monocytes between two intervention arms

    Measured: 3 months

  10. Percentage (%) of CD4+ (cluster of differentiation 4) T cells

    Difference in change-from-baseline percentage (%) of CD4+ T cells between two intervention arms

    Measured: 3 months

  11. Percentage (%) of CD8+ (cluster of differentiation 8) T cells

    Difference in change-from-baseline percentage (%) of CD8+ T cells between two intervention arms

    Measured: 3 months

  12. Percentage (%) of monocytes

    Difference in change-from-baseline percentage (%) of monocytes between two intervention arms

    Measured: 3 months

  13. Lean tissue mass (kg)

    Difference in change-from-baseline lean tissue mass (kg) between two intervention arms

    Measured: 3 months

  14. Fat tissue mass (kg)

    Difference in change-from-baseline fat tissue index (kg) between two intervention arms

    Measured: 3 months

  15. Lean tissue index (kg/m2)

    Difference in change-from-baseline lean tissue index (kg/m2) between two intervention arms

    Measured: 3 months

  16. Fat tissue index (kg/m2)

    Difference in change-from-baseline fat tissue index (kg/m2) between two intervention arms

    Measured: 3 months

  17. Percentage (%) of body fat mass

    Difference in change-from-baseline percentage (%) of body fat mass between two intervention arms

    Measured: 3 months

  18. Percentage (%) of excess body fat

    Difference in change-from-baseline percentage (%) of excess body fat between two intervention arms. Excess body fat is defined as fat percentage > 25 % for men or > 35 % for women

    Measured: 3 months

  19. Percentage (%) of obesity

    Difference in change-from-baseline percentage (%) of obesity between two intervention arms. Obesity is defined as body mass index > 24.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2020
  2. Study start2 Oct 2020
  3. Primary completion31 Oct 2023
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
A randomized, active-controlled trial with cross-over design
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04546958
Sponsor's protocol ID
FEMH-IRB-109116-F
Status last verified
Feb 2025
First submitted
6 Sep 2020
Last updated
25 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual-level deidentified participant data will be made available by the corresponding author of the paper upon request by email. The data will be available for 3 years after formal publication.

Questions about this trial

What is this clinical trial studying?

A study testing Whey protein supplements and Nutritional counseling in people with End Stage Renal Disease on Dialysis, run by Far Eastern Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentrations of albumin (g/dL) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in