Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377293
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-15
Brief Title:
Effect of Dialysis-specific Therapeutic Diet on Biochemical Parameters in Dialysis Patients
Sponsor:
Far Eastern Memorial Hospital
Organization:
Far Eastern Memorial Hospital
Study Overview
Official Title:
Effects of Dialysis-specific Therapeutic Diet in Dialysis Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In patients with kidney failure disturbances in bone turnover mineral metabolism vascular calcification uremia inflammation immunity nutrition and gut microbial metabolites are frequent Unhealthy diet causes altered mineral metabolism elevated uremic toxin level immune dysregulation inflammation protein-energy wasting and dysbiosis The investigators hypothesize that therapeutic diet intervention reverses these uremic complications and thereby reduces cardiovascular risk in patients with kidney failure In this study the investigators crafted 4-week dialysis-specific therapeutic diet to illustrate the clinical implications of therapeutic diet for dialysis patients
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None