Dietary Therapy in Dialysis Patients

• Sponsor: Far Eastern Memorial Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04505462
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.1
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease on Dialysis	Other: Therapeutic diet	N/A

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

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: A randomized, active-controlled trial with cross-over designA randomized, active-controlled trial with cross-over design
• Masking: Single (Outcomes Assessor)
• Masking Description: Laboratory technicians who assess the study outcomes will be masked
• Primary Purpose: Treatment
• Official Title: Short-Term Effects of Therapeutic Diet in Dialysis Patients
• Actual Study Start Date: Oct 28, 2020
• Actual Primary Completion Date: Dec 10, 2020
• Actual Study Completion Date: Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study diet 7-day therapeutic diet intervention as experimental group	Other: Therapeutic diet; A special healthy diet for dialysis patients; Other Names: Dietary therapy
No Intervention: Usual diet 7-day usual diet as control group, no dietary intervention in this group, participants consumed their habitual diet

Outcome Measures

Primary Outcome Measures

1. Concentrations of intact fibroblast growth factor 23 (pg/mL) [7 days]

   Difference in change-from-baseline intact fibroblast growth factor 23 (pg/mL) between therapeutic diet and usual diet

Secondary Outcome Measures

1. Concentrations of C-terminal fibroblast growth factor 23 (RU/mL) [7 days]

   Difference in change-from-baseline C-terminal fibroblast growth factor 23 (RU/mL) between therapeutic diet and usual diet

2. Concentrations of phosphate (mg/dL) [7 days]

   Difference in change-from-baseline phosphate (mg/dL) between therapeutic diet and usual diet

3. Concentrations of calcium (mg/dL) [7 days]

   Difference in change-from-baseline calcium (mg/dL) between therapeutic diet and usual diet

4. Concentrations of intact parathyroid hormone (pg/mL) [7 days]

   Difference in change-from-baseline intact parathyroid hormone (pg/mL) between therapeutic diet and usual diet

5. Concentrations of free indoxyl sulfate (mg/L) [7 days]

   Difference in change-from-baseline free indoxyl sulfate (mg/L) between therapeutic diet and usual diet

6. Concentrations of free p-cresol sulfate (mg/L) [7 days]

   Difference in change-from-baseline free p-cresol sulfate (mg/L) between therapeutic diet and usual diet

7. Concentrations of pre-albumin (g/dL) [7 days]

   Difference in change-from-baseline pre-albumin (g/dL) between therapeutic diet and usual diet

8. Concentrations of albumin (g/dL) [7 days]

   Difference in change-from-baseline albumin (g/dL) between therapeutic diet and usual diet

9. Concentrations of C-reactive protein (mg/dL) [7 days]

   Difference in change-from-baseline C-reactive protein (mg/dL) between therapeutic diet and usual diet

10. Absolute number (per μl blood) of CD4+ (cluster of differentiation 4) T cells [7 days]

    Difference in change-from-baseline absolute number (per μl blood) of CD4+ T cells between therapeutic diet and usual diet

11. Absolute number (per μl blood) of CD8+ (cluster of differentiation 8) T cells [7 days]

    Difference in change-from-baseline absolute number (per μl blood) of CD8+ T cells between therapeutic diet and usual diet

12. Absolute number (per μl blood) of monocytes [7 days]

    Difference in change-from-baseline absolute number (per μl blood) of monocytes between therapeutic diet and usual diet

13. Percentage (%) of CD4+ (cluster of differentiation 4) T cells [7 days]

    Difference in change-from-baseline percentage (%) of CD4+ (cluster of differentiation 4) T cells between therapeutic diet and usual diet

14. Percentage (%) of CD8+ (cluster of differentiation 8) T cells [7 days]

    Difference in change-from-baseline percentage (%) of CD8+ (cluster of differentiation 8) T cells between therapeutic diet and usual diet

15. Percentage (%) of monocytes [7 days]

    Difference in change-from-baseline percentage (%) of monocytes between therapeutic diet and usual diet

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. Serum albumin level less than 2.5 g/dL

2. Hospitalization within the past 4 weeks

3. Prebiotics, probiotics, symbiotics or antibiotics use within the past 4 weeks

4. History of psychiatric disorders

5. Having mental retardation

6. Those who dislike of the study meals

7. Soft diet requirement

8. Vegetarian

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Far Eastern Memorial Hospital	New Taipei City		Taiwan

Sponsors and Collaborators

• Far Eastern Memorial Hospital

Investigators

• Principal Investigator: Wan-Chuan Tsai, M.D., Ph.D., Far Eastern Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Wan-Chuan Tsai, Principal Investigator, Assistant Professor, Far Eastern Memorial Hospital
• ClinicalTrials.gov Identifier: NCT04505462
• Other Study ID Numbers: FEMH-IRB-109112-F
• First Posted: Aug 10, 2020
• Last Update Posted: Mar 16, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wan-Chuan Tsai, Principal Investigator, Assistant Professor, Far Eastern Memorial Hospital: Therapeutic diet; Mineral metabolism; Uremic toxins; Inflammation; Immune; End-stage kidney disease
• Additional relevant MeSH terms: Kidney Failure, Chronic

Study Results

No Results Posted as of Mar 16, 2022