End Stage Renal Disease on DialysisNCT04505462
Dietary Therapy in Dialysis Patients
A study testing Therapeutic diet in people with End Stage Renal Disease on Dialysis, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Patients with end-stage kidney disease have hyperphosphatemia and accumulated uremic toxin level due to decreased urine excretion ability. Unhealthy diet causes altered mineral metabolism, elevated uremic toxin level, immune dysregulation, and inflammation. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- What is being tested?
- Therapeutic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Oct 2020to 1 Mar 2022
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with aged older than 20 years, ESKD undergoing maintenance dialysis for more than three months, having adequate dialysis, serum intact parathyroid hormone less than 800 pg/mL and good dietary compliance
Who cannot join
- Patients who meet any of the following criteria will be excluded from the study:
- Serum albumin level less than 2.5 g/dL
- Hospitalization within the past 4 weeks
- Prebiotics, probiotics, symbiotics or antibiotics use within the past 4 weeks
- History of psychiatric disorders
- Having mental retardation
Show all 9Show fewer
- Those who dislike of the study meals
- Soft diet requirement
- Vegetarian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-Term Effects of Therapeutic Diet in Dialysis Patients
Patients with end-stage kidney disease have hyperphosphatemia and accumulated uremic toxin level due to decreased urine excretion ability. Unhealthy diet causes altered mineral metabolism, elevated uremic toxin level, immune dysregulation, and inflammation. The investigators hypothesize that therapeutic diet intervention reverses altered mineral metabolism, elevated uremic toxin level, immune dysregulation, and inflammation. In this study, the investigators crafted 7-day special healthy diet to illustrate the clinical implications of therapeutic diet for dialysis patients.
Read the detailed description
The risk of cardiovascular disease (CVD) and mortality in patients with end-stage kidney disease (ESKD) is far greater than those in the general population. Emerging evidence suggests that unhealthy diet causes altered mineral metabolism, disturbance of gut microbiota (dysbiosis) with elevated uremic toxin level, immune dysregulation, and inflammation; these abnormalities are strongly related to development of CVD. Little is known about the relationship between therapeutic diet intervention and cardiovascular risk in patients with ESKD. Recently, the study of the investigators showed that ESKD patients undergoing hemodialysis who consumed very low-phosphate diet, phosphate-to-protein ratio (PPR) value of 8 mg/g, experienced an extra reduction of serum phosphorus level by 0.61 mg/dL compared with that of low-phosphate diet, PPR value of 10 mg/g.
The aim of the study is to explore the effect of 7-day therapeutic diet intervention on changes of altered mineral metabolism, uremic toxin production, immune dysregulation and inflammation, highlighting the important role of dietary modification in dialysis population.
It is to conduct a randomized controlled trial with cross-over design at a hemodialysis unit of tertiary teaching hospital in Northern Taiwan. Subjects with aged older than 20 years, ESKD undergoing maintenance dialysis for more than three months, having adequate dialysis and serum intact parathyroid hormone less than 800 pg/mL will be included. Participants will be randomly assigned into two groups: those in group A will receive study diet for 7 days, followed by 4-week washout period and then receive 7-day usual diet. The opposite order of diets will be prescribed in group B. The study meals are prepared in the hospital cafeteria. Dietary compositions of the study diets were analyzed before the start of the study. The study outcome measures are difference in change-from-baseline values of altered mineral metabolism, uremic toxin production, immune dysregulation and inflammation between the therapeutic diet and the usual diet.
- Conditions
- End Stage Renal Disease on Dialysis
- Being tested
- Therapeutic diet
- Keywords
- Therapeutic diet, Mineral metabolism, Uremic toxins, Inflammation, Immune, End-stage kidney disease
- Medical subject headings
- Inflammation, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic dietOther
Also called Dietary therapy
A special healthy diet for dialysis patients
| Study group | Role | What they receive |
|---|---|---|
| Study diet | Experimental | 7-day therapeutic diet intervention as experimental group Receives: Other: Therapeutic diet |
| Usual diet | No intervention | 7-day usual diet as control group, no dietary intervention in this group, participants consumed their habitual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of intact fibroblast growth factor 23 (pg/mL)
Difference in change-from-baseline intact fibroblast growth factor 23 (pg/mL) between therapeutic diet and usual diet
Measured: 7 days
Secondary outcomes (15)
Concentrations of C-terminal fibroblast growth factor 23 (RU/mL)
Difference in change-from-baseline C-terminal fibroblast growth factor 23 (RU/mL) between therapeutic diet and usual diet
Measured: 7 days
Concentrations of phosphate (mg/dL)
Difference in change-from-baseline phosphate (mg/dL) between therapeutic diet and usual diet
Measured: 7 days
Concentrations of calcium (mg/dL)
Difference in change-from-baseline calcium (mg/dL) between therapeutic diet and usual diet
Measured: 7 days
Concentrations of intact parathyroid hormone (pg/mL)
Difference in change-from-baseline intact parathyroid hormone (pg/mL) between therapeutic diet and usual diet
Measured: 7 days
Concentrations of free indoxyl sulfate (mg/L)
Difference in change-from-baseline free indoxyl sulfate (mg/L) between therapeutic diet and usual diet
Measured: 7 days
Concentrations of free p-cresol sulfate (mg/L)
Difference in change-from-baseline free p-cresol sulfate (mg/L) between therapeutic diet and usual diet
Measured: 7 days
Concentrations of pre-albumin (g/dL)
Difference in change-from-baseline pre-albumin (g/dL) between therapeutic diet and usual diet
Measured: 7 days
Concentrations of albumin (g/dL)
Difference in change-from-baseline albumin (g/dL) between therapeutic diet and usual diet
Measured: 7 days
Concentrations of C-reactive protein (mg/dL)
Difference in change-from-baseline C-reactive protein (mg/dL) between therapeutic diet and usual diet
Measured: 7 days
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 therapeutic diet and usual diet
Measured: 7 days
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 therapeutic diet and usual diet
Measured: 7 days
Absolute number (per μl blood) of monocytes
Difference in change-from-baseline absolute number (per μl blood) of monocytes between therapeutic diet and usual diet
Measured: 7 days
Percentage (%) of CD4+ (cluster of differentiation 4) T cells
Difference in change-from-baseline percentage (%) of CD4+ (cluster of differentiation 4) T cells between therapeutic diet and usual diet
Measured: 7 days
Percentage (%) of CD8+ (cluster of differentiation 8) T cells
Difference in change-from-baseline percentage (%) of CD8+ (cluster of differentiation 8) T cells between therapeutic diet and usual diet
Measured: 7 days
Percentage (%) of monocytes
Difference in change-from-baseline percentage (%) of monocytes between therapeutic diet and usual diet
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start28 Oct 2020
- Primary completion10 Dec 2020
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 32 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
- NCT04505462
- Sponsor's protocol ID
- FEMH-IRB-109112-F
- Status last verified
- Mar 2022
- First submitted
- 31 Jul 2020
- Last updated
- 16 Mar 2022
- 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.
Publications
Tsai WC, Wu HY, Peng YS, Hsu SP, Chiu YL, Yang JY, Chen HY, Pai MF, Lin WY, Hung KY, Chu FY, Tsai SM, Chien KL. Short-Term Effects of Very-Low-Phosphate and Low-Phosphate Diets on Fibroblast Growth Factor 23 in Hemodialysis Patients: A Randomized Crossover Trial. Clin J Am Soc Nephrol. 2019 Oct 7;14(10):1475-1483. doi: 10.2215/CJN.04250419. Epub 2019 Sep 13.
PubMed 31519550Tsai WC, Wu HY, Peng YS, Hsu SP, Chiu YL, Chen HY, Yang JY, Ko MJ, Pai MF, Tu YK, Hung KY, Chien KL. Effects of lower versus higher phosphate diets on fibroblast growth factor-23 levels in patients with chronic kidney disease: a systematic review and meta-analysis. Nephrol Dial Transplant. 2018 Nov 1;33(11):1977-1983. doi: 10.1093/ndt/gfy005.
PubMed 29420827Tsai WC, Hsu SP, Chiu YL, Wu HY, Luan CC, Yang JY, Pai MF, Lin CJ, Lin WY, Sun WH, Peng YS. Short-Term Effects of a Therapeutic Diet on Biochemical Parameters in Hemodialysis Patients: A Randomized Crossover Trial. J Ren Nutr. 2023 Nov;33(6):731-739. doi: 10.1053/j.jrn.2023.04.003. Epub 2023 Apr 27.
PubMed 37120127
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Effects of Therapeutic Diet in Dialysis Patients
- ClinicalTrials.gov ID
- NCT04505462
- Acronym / sponsor ID
- FEMH-IRB-109112-F
- Conditions
- End Stage Renal Disease on Dialysis
- Keywords
- Therapeutic diet, Mineral metabolism, Uremic toxins, Inflammation, Immune, End-stage kidney disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 10 Aug 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.
Patients with end-stage kidney disease have hyperphosphatemia and accumulated uremic toxin level due to decreased urine excretion ability. Unhealthy diet causes altered mineral metabolism, elevated uremic toxin level, immune dysregulation, and inflammation. The investigators hypothesize that therapeutic diet intervention reverses altered mineral metabolism, elevated uremic toxin level, immune dysregulation, and inflammation. In this study, the investigators crafted 7-day special healthy diet to illustrate the clinical implications of therapeutic diet for dialysis patients.
Detailed description
The risk of cardiovascular disease (CVD) and mortality in patients with end-stage kidney disease (ESKD) is far greater than those in the general population. Emerging evidence suggests that unhealthy diet causes altered mineral metabolism, disturbance of gut microbiota (dysbiosis) with elevated uremic toxin level, immune dysregulation, and inflammation; these abnormalities are strongly related to development of CVD. Little is known about the relationship between therapeutic diet intervention and cardiovascular risk in patients with ESKD. Recently, the study of the investigators showed that ESKD patients undergoing hemodialysis who consumed very low-phosphate diet, phosphate-to-protein ratio (PPR) value of 8 mg/g, experienced an extra reduction of serum phosphorus level by 0.61 mg/dL compared with that of low-phosphate diet, PPR value of 10 mg/g.
The aim of the study is to explore the effect of 7-day therapeutic diet intervention on changes of altered mineral metabolism, uremic toxin production, immune dysregulation and inflammation, highlighting the important role of dietary modification in dialysis population.
It is to conduct a randomized controlled trial with cross-over design at a hemodialysis unit of tertiary teaching hospital in Northern Taiwan. Subjects with aged older than 20 years, ESKD undergoing maintenance dialysis for more than three months, having adequate dialysis and serum intact parathyroid hormone less than 800 pg/mL will be included. Participants will be randomly assigned into two groups: those in group A will receive study diet for 7 days, followed by 4-week washout period and then receive 7-day usual diet. The opposite order of diets will be prescribed in group B. The study meals are prepared in the hospital cafeteria. Dietary compositions of the study diets were analyzed before the start of the study. The study outcome measures are difference in change-from-baseline values of altered mineral metabolism, uremic toxin production, immune dysregulation and inflammation between the therapeutic diet and the usual diet.
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 |
|---|---|---|
| Study diet | Experimental | Other: Therapeutic diet7-day therapeutic diet intervention as experimental group |
| Usual diet | No intervention | –7-day usual diet as control group, no dietary intervention in this group, participants consumed their habitual diet |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with aged older than 20 years, ESKD undergoing maintenance dialysis for more than three months, having adequate dialysis, serum intact parathyroid hormone less than 800 pg/mL and good dietary compliance
Key exclusion criteria (9 listed)
- Patients who meet any of the following criteria will be excluded from the study:
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 |
|---|---|---|
| Therapeutic dietAlso: Dietary therapyA special healthy diet for dialysis patients | Other | Study diet |
Primary outcome
Concentrations of intact fibroblast growth factor 23 (pg/mL)
Time frame: 7 days
Difference in change-from-baseline intact fibroblast growth factor 23 (pg/mL) between therapeutic diet and usual diet
15 secondary outcomes
Concentrations of C-terminal fibroblast growth factor 23 (RU/mL)
Time frame: 7 days
Concentrations of phosphate (mg/dL)
Time frame: 7 days
Concentrations of calcium (mg/dL)
Time frame: 7 days
Concentrations of intact parathyroid hormone (pg/mL)
Time frame: 7 days
Concentrations of free indoxyl sulfate (mg/L)
Time frame: 7 days
Concentrations of free p-cresol sulfate (mg/L)
Time frame: 7 days
Concentrations of pre-albumin (g/dL)
Time frame: 7 days
Concentrations of albumin (g/dL)
Time frame: 7 days
Concentrations of C-reactive protein (mg/dL)
Time frame: 7 days
Absolute number (per μl blood) of CD4+ (cluster of differentiation 4) T cells
Time frame: 7 days
Absolute number (per μl blood) of CD8+ (cluster of differentiation 8) T cells
Time frame: 7 days
Absolute number (per μl blood) of monocytes
Time frame: 7 days
Percentage (%) of CD4+ (cluster of differentiation 4) T cells
Time frame: 7 days
Percentage (%) of CD8+ (cluster of differentiation 8) T cells
Time frame: 7 days
Percentage (%) of monocytes
Time frame: 7 days
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 16 Mar 2022.
- Background: PubMed 31519550Tsai WC, Wu HY, Peng YS, Hsu SP, Chiu YL, Yang JY, Chen HY, Pai MF, Lin WY, Hung KY, Chu FY, Tsai SM, Chien KL. Short-Term Effects of Very-Low-Phosphate and Low-Phosphate Diets on Fibroblast Growth Factor 23 in Hemodialysis Patients: A Randomized Crossover Trial. Clin J Am Soc Nephrol. 2019 Oct 7;14(10):1475-1483. doi: 10.2215/CJN.04250419. Epub 2019 Sep 13.
- Background: PubMed 29420827Tsai WC, Wu HY, Peng YS, Hsu SP, Chiu YL, Chen HY, Yang JY, Ko MJ, Pai MF, Tu YK, Hung KY, Chien KL. Effects of lower versus higher phosphate diets on fibroblast growth factor-23 levels in patients with chronic kidney disease: a systematic review and meta-analysis. Nephrol Dial Transplant. 2018 Nov 1;33(11):1977-1983. doi: 10.1093/ndt/gfy005.
- Derived from this study: PubMed 37120127Tsai WC, Hsu SP, Chiu YL, Wu HY, Luan CC, Yang JY, Pai MF, Lin CJ, Lin WY, Sun WH, Peng YS. Short-Term Effects of a Therapeutic Diet on Biochemical Parameters in Hemodialysis Patients: A Randomized Crossover Trial. J Ren Nutr. 2023 Nov;33(6):731-739. doi: 10.1053/j.jrn.2023.04.003. Epub 2023 Apr 27.
- 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.
Related trials for End Stage Renal Disease on Dialysis
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Not yet recruiting
Effects of Horticultural Therapy on Acute Stress and Salivary Cortisol Levels in Hemodialysis Patients
End-Stage Renal Disease, Renal Dialysis
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
RecruitingPhase 2
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
End Stage Renal Disease on Dialysis, Peritoneal Dialysis Complication
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 Therapeutic diet 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 1 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 16 Mar 2022. 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 intact fibroblast growth factor 23 (pg/mL) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04505462, which also lists 3 linked publications.
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 16 Mar 2022.