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.
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.
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.
- Conditions
- End Stage Renal Disease on Dialysis
- 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 group | Role | What they receive |
|---|---|---|
| Nutritional counseling arm | Active comparator | Nutritional 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 arm | Experimental | Nutritional 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.
Concentrations of albumin (g/dL)
Difference in change-from-baseline albumin (g/dL) between two intervention arms
Measured: 3 months
Secondary outcomes (19)
Concentrations of pre-albumin (g/dL)
Difference in change-from-baseline pre-albumin (g/dL) between two intervention arms
Measured: 3 months
Concentrations of C-reactive protein (mg/dL)
Difference in change-from-baseline C-reactive protein (mg/dL) between two intervention arms
Measured: 3 months
Concentrations of phosphate (mg/dL)
Difference in change-from-baseline phosphate (mg/dL) between two intervention arms
Measured: 3 months
Concentrations of blood urea nitrogen (mg/dL)
Difference in change-from-baseline blood urea nitrogen (mg/dL) between two intervention arms
Measured: 3 months
Concentrations of free indoxyl sulfate (mg/L)
Difference in change-from-baseline free indoxyl sulfate (mg/L) between two intervention arms
Measured: 3 months
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
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
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
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
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
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
Percentage (%) of monocytes
Difference in change-from-baseline percentage (%) of monocytes between two intervention arms
Measured: 3 months
Lean tissue mass (kg)
Difference in change-from-baseline lean tissue mass (kg) between two intervention arms
Measured: 3 months
Fat tissue mass (kg)
Difference in change-from-baseline fat tissue index (kg) between two intervention arms
Measured: 3 months
Lean tissue index (kg/m2)
Difference in change-from-baseline lean tissue index (kg/m2) between two intervention arms
Measured: 3 months
Fat tissue index (kg/m2)
Difference in change-from-baseline fat tissue index (kg/m2) between two intervention arms
Measured: 3 months
Percentage (%) of body fat mass
Difference in change-from-baseline percentage (%) of body fat mass between two intervention arms
Measured: 3 months
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
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.
- First posted14 Sep 2020
- Study start2 Oct 2020
- Primary completion31 Oct 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease on DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan-Chuan Tsai, Far Eastern Memorial Hospital
- Investigators
- Wan-Chuan Tsai, M.D., Ph.D., Principal investigator, Far Eastern Memorial Hospital
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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Implication of Nutritional Counseling and Whey Protein Supplements in Patients on Peritoneal Dialysis with Hypoalbuminemia
- ClinicalTrials.gov ID
- NCT04546958
- Acronym / sponsor ID
- FEMH-IRB-109116-F
- Conditions
- End Stage Renal Disease on Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, active-controlled trial with cross-over design
| Arm | Type | Receives |
|---|---|---|
| Nutritional counseling arm | Active comparator | Other: Nutritional counselingNutritional counseling, targeting daily protein intake 1.2 g/kg Dietitian will provide one-to-one dietary education, 30 minutes duration, on a monthly basis |
| Nutritional counseling plus whey protein supplements arm | Experimental | Dietary Supplement: Whey protein supplements, Other: Nutritional counselingNutritional 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Untreated fluid overload
- Uncorrected metabolic acidosis
- Having active infection or inflammation
- Hospitalization within the past 4 weeks
- Having gastrointestinal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey protein supplementsNutritional counseling and whey protein supplements for 3 months | Dietary supplement | Nutritional counseling plus whey protein supplements arm |
| Nutritional counselingNutritional counseling by dietitians for 3 months | Other | Nutritional counseling arm, Nutritional counseling plus whey protein supplements arm |
Primary outcome
Concentrations of albumin (g/dL)
Time frame: 3 months
Difference in change-from-baseline albumin (g/dL) between two intervention arms
19 secondary outcomes
Concentrations of pre-albumin (g/dL)
Time frame: 3 months
Concentrations of C-reactive protein (mg/dL)
Time frame: 3 months
Concentrations of phosphate (mg/dL)
Time frame: 3 months
Concentrations of blood urea nitrogen (mg/dL)
Time frame: 3 months
Concentrations of free indoxyl sulfate (mg/L)
Time frame: 3 months
Concentrations of free p-cresol sulfate (mg/L)
Time frame: 3 months
Absolute number (per μl blood) of CD4+ (cluster of differentiation 4) T cells
Time frame: 3 months
Absolute number (per μl blood) of CD8+ (cluster of differentiation 8) T cells
Time frame: 3 months
Absolute number (per μl blood) of monocytes
Time frame: 3 months
Percentage (%) of CD4+ (cluster of differentiation 4) T cells
Time frame: 3 months
Percentage (%) of CD8+ (cluster of differentiation 8) T cells
Time frame: 3 months
Percentage (%) of monocytes
Time frame: 3 months
Lean tissue mass (kg)
Time frame: 3 months
Fat tissue mass (kg)
Time frame: 3 months
Lean tissue index (kg/m2)
Time frame: 3 months
Fat tissue index (kg/m2)
Time frame: 3 months
Percentage (%) of body fat mass
Time frame: 3 months
Percentage (%) of excess body fat
Time frame: 3 months
Percentage (%) of obesity
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wan-Chuan Tsai, M.D., Ph.D. principal investigator
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
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.