- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04505462
Dietary Therapy in Dialysis Patients
Short-Term Effects of Therapeutic Diet in Dialysis Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
New Taipei City, Taiwan
- Far Eastern Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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
- Those who dislike of the study meals
- Soft diet requirement
- Vegetarian
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study diet
7-day therapeutic diet intervention as experimental group
|
A special healthy diet for dialysis patients
Other Names:
|
No Intervention: Usual diet
7-day usual diet as control group, no dietary intervention in this group, participants consumed their habitual diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentrations of C-terminal fibroblast growth factor 23 (RU/mL)
Time Frame: 7 days
|
Difference in change-from-baseline C-terminal fibroblast growth factor 23 (RU/mL) between therapeutic diet and usual diet
|
7 days
|
Concentrations of phosphate (mg/dL)
Time Frame: 7 days
|
Difference in change-from-baseline phosphate (mg/dL) between therapeutic diet and usual diet
|
7 days
|
Concentrations of calcium (mg/dL)
Time Frame: 7 days
|
Difference in change-from-baseline calcium (mg/dL) between therapeutic diet and usual diet
|
7 days
|
Concentrations of intact parathyroid hormone (pg/mL)
Time Frame: 7 days
|
Difference in change-from-baseline intact parathyroid hormone (pg/mL) between therapeutic diet and usual diet
|
7 days
|
Concentrations of free indoxyl sulfate (mg/L)
Time Frame: 7 days
|
Difference in change-from-baseline free indoxyl sulfate (mg/L) between therapeutic diet and usual diet
|
7 days
|
Concentrations of free p-cresol sulfate (mg/L)
Time Frame: 7 days
|
Difference in change-from-baseline free p-cresol sulfate (mg/L) between therapeutic diet and usual diet
|
7 days
|
Concentrations of pre-albumin (g/dL)
Time Frame: 7 days
|
Difference in change-from-baseline pre-albumin (g/dL) between therapeutic diet and usual diet
|
7 days
|
Concentrations of albumin (g/dL)
Time Frame: 7 days
|
Difference in change-from-baseline albumin (g/dL) between therapeutic diet and usual diet
|
7 days
|
Concentrations of C-reactive protein (mg/dL)
Time Frame: 7 days
|
Difference in change-from-baseline C-reactive protein (mg/dL) between therapeutic diet and usual diet
|
7 days
|
Absolute number (per μl blood) of CD4+ (cluster of differentiation 4) T cells
Time Frame: 7 days
|
Difference in change-from-baseline absolute number (per μl blood) of CD4+ T cells between therapeutic diet and usual diet
|
7 days
|
Absolute number (per μl blood) of CD8+ (cluster of differentiation 8) T cells
Time Frame: 7 days
|
Difference in change-from-baseline absolute number (per μl blood) of CD8+ T cells between therapeutic diet and usual diet
|
7 days
|
Absolute number (per μl blood) of monocytes
Time Frame: 7 days
|
Difference in change-from-baseline absolute number (per μl blood) of monocytes between therapeutic diet and usual diet
|
7 days
|
Percentage (%) of CD4+ (cluster of differentiation 4) T cells
Time Frame: 7 days
|
Difference in change-from-baseline percentage (%) of CD4+ (cluster of differentiation 4) T cells between therapeutic diet and usual diet
|
7 days
|
Percentage (%) of CD8+ (cluster of differentiation 8) T cells
Time Frame: 7 days
|
Difference in change-from-baseline percentage (%) of CD8+ (cluster of differentiation 8) T cells between therapeutic diet and usual diet
|
7 days
|
Percentage (%) of monocytes
Time Frame: 7 days
|
Difference in change-from-baseline percentage (%) of monocytes between therapeutic diet and usual diet
|
7 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Tsai 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FEMH-IRB-109112-F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on End Stage Renal Disease on Dialysis
-
Nanyang Technological UniversityNational Kidney Foundation, SingaporeRecruitingEnd Stage Renal Disease | End Stage Kidney Disease | End Stage Renal Failure on Dialysis | End Stage Renal Disease on DialysisSingapore
-
Peripal AGUniversity Hospital Birmingham NHS Foundation Trust; Swiss Federal Institute...CompletedRenal Failure | Peritoneal Dialysis | Renal Replacement Therapy | End Stage Renal Failure on Dialysis | End Stage Renal Disease on DialysisUnited Kingdom
-
Satellite HealthcareCompletedEnd Stage Renal Disease on Dialysis | Home DialysisUnited States
-
Sun Yat-sen UniversityRecruiting
-
Outset MedicalCompletedAcute Kidney Injury | End Stage Renal Disease (ESRD) | End Stage Renal Disease on DialysisUnited States
-
Centre Hospitalier Universitaire de BesanconRecruitingPeritoneal Dialysis | End Stage Renal Disease on DialysisFrance
-
Kaohsiung Medical University Chung-Ho Memorial...National Sun Yat-sen UniversityRecruiting
-
RenJi HospitalNot yet recruitingEnd Stage Renal Disease on DialysisChina
-
Réseau de Santé Vitalité Health NetworkUnknownEnd Stage Renal Disease on DialysisCanada
-
University of AarhusCompletedEnd Stage Renal Disease on DialysisDenmark
Clinical Trials on Therapeutic diet
-
University of California, San DiegoRecruiting
-
KTO Karatay UniversityCompleted
-
The University of The West IndiesCompletedDiabetes | Metabolic Syndrome | Blood Pressure | TriglyceridesTrinidad and Tobago
-
Pingale, Vidya, OTRTina S. Fletcher, EdD, MFA, OTR; Catherine Candler, PhD, OTR; Noralyn Pickens... and other collaboratorsCompletedSensory Processing Disorder | Autism | Special EducationUnited States
-
University of JazanCompletedAutistic Spectrum DisorderSaudi Arabia
-
University of CalgaryUniversity of British Columbia; University of Alberta; University of Guelph; University... and other collaboratorsActive, not recruiting
-
Terry L. WahlsActive, not recruitingClinically Isolated Syndrome | Relapsing Remitting Multiple SclerosisUnited States
-
University of Kansas Medical CenterNational Institute on Aging (NIA)Recruiting
-
Roy La Touche ArbizuUniversidad Autonoma de Madrid; Centro Universitario La Salle; Servicio Madrileño...UnknownLow Back Pain | Chronic Nonspecific Low Back PainSpain
-
University of TorontoCanadian Institutes of Health Research (CIHR); Unilever R&D; Loblaw Companies... and other collaboratorsCompletedCardiovascular Disease | HyperlipidemiaCanada