- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06377293
Effect of Dialysis-specific Therapeutic Diet on Biochemical Parameters in Dialysis Patients
Effects of Dialysis-specific Therapeutic Diet in Dialysis Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In patients with kidney failure, disturbance in bone turnover and mineral metabolism, and nutritional deficiency is prevalent, leading to vascular calcification, uremia, inflammation, immune dysregulation, and gut microbial dysbiosis, and these abnormalities are associated with increased risk of fracture, extraskeletal or vascular calcification and cardiovascular mortality. It is well known that an unhealthy diet plays an important role in bone-mineral metabolism, uremia, inflammation, protein-energy wasting, and dysbiosis, and therefore nutritional therapy may help to manage these uremic complications to reduce cardiovascular risk in patients with kidney failure. Importantly, serum biomarkers regarding the above-mentioned abnormalities are acutely and closely related to food intake. To our knowledge, no study to date has examined the multifactorial effects of nutritional intervention on bone turnover, mineral metabolism, vascular calcification, uremia, inflammation, immunity, nutrition, and gut microbial metabolites in dialysis patients.
To examine the beneficial effects of nutritional intervention on clinical outcomes, the investigators crafted the dialysis-specific therapeutic diet which was characterized by adequate calorie and protein amounts, natural food ingredients with a low phosphorus-to-protein ratio, higher portions of plant-based food, and high fiber content. In the previous studies, the investigators found that the therapeutic diet rapidly reversed mineral abnormalities within the 1-week intervention period. Among these changes, reduction in serum phosphate level achieved in 2 days, modifications of intact parathyroid hormone (PTH) and calcium levels in 5 days, and reductions in intact and C-terminal fibroblast growth factor-23 (FGF23) levels in 7 days of therapeutic diet intervention. Although the therapeutic diet tended to change uremic toxin level, neither inflammatory nor nutritional markers changed which may be explained by short duration of intervention. It is of interest to know whether the therapeutic diet has a favorable effect on bone turnover, vascular calcification, and gut microbial dysbiosis. In this continuity planning, the investigators are therefore going to analyze the 4-week diet-induced changes in biomarkers regarding bone turnover, vascular calcification, and gut microbial metabolites in addition to the previously assessed mineral metabolism, uremia, inflammation, immunity, and nutrition in dialysis patients.
This project aims to explore the multiple diverse effects of dialysis-specific healthy diet on the changes of bone turnover, mineral metabolism, vascular calcification, uremia, inflammation, immunity, nutrition, and gut microbial metabolites in dialysis patients. In contrast to the previous approaches, bone biomarkers for both of bone formation and bone resorption, vascular calcification biomarkers, and gut microbial metabolites will be comprehensively examined. Revealing a complex correlation between the nutritional factors and bone turnover, mineral metabolism, vascular calcification, uremia, inflammation, immunity, nutrition, and gut microbial dysbiosis, this project may shed light on understanding of diet-mediated bone-mineral and uremic homeostasis and uncover strategies of nutritional therapy. A better knowledge of diet-induced pathway on human body homeostasis may lead to new strategies for preventing fracture, vascular calcification or cardiovascular disease risk.
It is to conduct a randomized controlled trial with cross-over design at a dialysis unit of tertiary teaching hospital in Northern Taiwan. Subjects with aged older than 20 years, end-stage kidney disease (ESKD) undergoing maintenance dialysis for more than three months, having adequate dialysis and good dietary compliance will be included. Participants will be randomly assigned into two groups: group A and group B. Those in group A will receive study diet for 4 weeks, followed by 16-week washout period and then receive 4-week 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 abnormal mineral metabolism, altered bone turnover, vascular calcification, uremic toxin production, immune dysregulation, nutrition, inflammation and gut microbial metabolites between the therapeutic diet and the usual diet.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wan-Chuan Tsai, M.D., Ph.D.
- Phone Number: +886277281780
- Email: mkks618@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects with aged older than 20 years
- End-stage kidney disease (ESKD) undergoing maintenance dialysis for more than three months
- Must have adequate dialysis
- Good dietary compliance
Exclusion Criteria:
- 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
4-week therapeutic diet intervention as experimental group
|
A healthy diet for dialysis patients
|
No Intervention: Usual diet
4-week 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: 4 weeks
|
Difference in change-from-baseline intact fibroblast growth factor 23 (pg/mL) between therapeutic diet and usual diet
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentrations of C-terminal fibroblast growth factor 23 (RU/mL)
Time Frame: 4 weeks
|
Difference in change-from-baseline C-terminal fibroblast growth factor 23 (RU/mL) between therapeutic diet and usual diet
|
4 weeks
|
Concentrations of phosphate (mg/dL)
Time Frame: 4 weeks
|
Difference in change-from-baseline phosphate (mg/dL) between therapeutic diet and usual diet
|
4 weeks
|
Concentrations of calcium (mg/dL)
Time Frame: 4 weeks
|
Difference in change-from-baseline calcium (mg/dL) between therapeutic diet and usual diet
|
4 weeks
|
Concentrations of intact parathyroid hormone (pg/mL)
Time Frame: 4 weeks
|
Difference in change-from-baseline intact parathyroid hormone (pg/mL) between therapeutic diet and usual diet
|
4 weeks
|
Concentrations of bone-specific alkaline phosphatase (μg/L)
Time Frame: 4 weeks
|
Difference in change-from-baseline bone-specific alkaline phosphatase (μg/L) between therapeutic diet and usual diet
|
4 weeks
|
Concentrations of procollagen-type 1 N-terminal-propeptide (P1NP) (ng/mL)
Time Frame: 4 weeks
|
Difference in change-from-baseline procollagen-type 1 N-terminal-propeptide (P1NP) (ng/mL) between therapeutic diet and usual diet
|
4 weeks
|
Concentrations of tartrate resistance acid phosphatase-5b (TRACP-5b) (mIU/ml)
Time Frame: 4 weeks
|
Difference in change-from-baseline tartrate resistance acid phosphatase-5b (TRACP-5b) (mIU/ml) between therapeutic diet and usual diet
|
4 weeks
|
Concentrations of alkaline phosphatase (ALP) (IU/L)
Time Frame: 4 weeks
|
Difference in change-from-baseline alkaline phosphatase (ALP) (IU/L) between therapeutic diet and usual diet
|
4 weeks
|
Concentrations of free indoxyl sulfate (mg/L)
Time Frame: 4 weeks
|
Difference in change-from-baseline free indoxyl sulfate (mg/L) between therapeutic diet and usual diet
|
4 weeks
|
Concentrations of free p-cresol sulfate (mg/L)
Time Frame: 4 weeks
|
Difference in change-from-baseline free p-cresol sulfate (mg/L) between therapeutic diet and usual diet
|
4 weeks
|
Concentrations of pre-albumin (g/dL)
Time Frame: 4 weeks
|
Difference in change-from-baseline pre-albumin (g/dL) between therapeutic diet and usual diet
|
4 weeks
|
Concentrations of albumin (g/dL)
Time Frame: 4 weeks
|
Difference in change-from-baseline albumin (g/dL) between therapeutic diet and usual diet
|
4 weeks
|
Concentrations of C-reactive protein (mg/dL)
Time Frame: 4 weeks
|
Difference in change-from-baseline C-reactive protein (mg/dL) between therapeutic diet and usual diet
|
4 weeks
|
Absolute number (per μl blood) of CD4+ (cluster of differentiation 4) T cells
Time Frame: 4 weeks
|
Difference in change-from-baseline absolute number (per μl blood) of CD4+ (cluster of differentiation 4) T cells between therapeutic diet and usual diet
|
4 weeks
|
Absolute number (per μl blood) of CD8+ (cluster of differentiation 8) T cells
Time Frame: 4 weeks
|
Difference in change-from-baseline absolute number (per μl blood) of CD8+ (cluster of differentiation 8) T cells between therapeutic diet and usual diet
|
4 weeks
|
Absolute number (per μl blood) of monocytes
Time Frame: 4 weeks
|
Difference in change-from-baseline absolute number (per μl blood) of monocytes between therapeutic diet and usual diet
|
4 weeks
|
Concentrations of fetuin-A (μg/ml)
Time Frame: 4 weeks
|
Difference in change-from-baseline fetuin-A (μg/ml) between therapeutic diet and usual diet
|
4 weeks
|
Concentrations of trimethylamine-N-oxide (TMAO) (μM)
Time Frame: 4 weeks
|
Difference in change-from-baseline trimethylamine-N-oxide (TMAO) (μM) between therapeutic diet and usual diet
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wan-Chuan Tsai, M.D., Ph.D., Far Eastern Memorial Hospital
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.
- Tsai WC, Peng YS, Wu HY, Hsu SP, Chiu YL, Liu LC, Tsai SM, Chien KL. Accuracy of a Nutrient Database in Estimating the Dietary Phosphorus-to-Protein Ratio and Using a Boiling Method in Low-Phosphate Hospital Diets. Sci Rep. 2018 Oct 15;8(1):15246. doi: 10.1038/s41598-018-33657-8.
- Tsai WC, Wu HY, Chiu YL, Yang JY, Pai MF, Wu YR, Lin WY, Hung KY, Chien KL, Hsu SP, Peng YS. Acute effects of dietary phosphorus intake on markers of mineral metabolism in hemodialysis patients: post hoc analysis of a randomized crossover trial. Ren Fail. 2021 Dec;43(1):141-148. doi: 10.1080/0886022X.2020.1870138.
- Tsai 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- FEMH-IRB-TSAI2024
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
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