Efficacy of Plant-protein Diets in Patients With Chronic Kidney Disease

Not Applicable

Active, not recruiting

• Conditions: Chronic Kidney Disease Stage 5
• Interventions: Other: Plant-protein Diets; Other: Control Diets

• Registration Number: NCT05350098
• Lead Sponsor: Osaka University

Brief Summary

The purpose of this study is to evaluate the efficacy of plant-protein diets for 12 weeks in patients with advanced chronic kidney disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-27
• Study Start: 2023-01-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-11-01
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. patients with chronic kidney disease who were referred to the Outpatient Department of Nephrology at Osaka University Hospital
2. eGFR < 20 mL/min/1.73 m2
3. taking anigiotensin-converting enzyme inhibitors or angiotensin Ⅱ receptor blockers or angiotensin receptor neprilysin inhibitor
4. K < 5.5 mEq/L

Exclusion Criteria

1. Being planned to intitate renal replacement therapies within 3 months
2. Having inflammatory bowel diseases
3. History of gastrointestinal tract surgery
4. Taking antibiotics within 1 month before the entry
5. Taking or being planned to start warfarin
6. Having dietary allergies
7. Having difficulty in oral intake
8. During pregnancy or breastfeeding
9. Unsuitable for participant in the trial by an attending physician

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A dietary intervention of plant-protein based diets	Plant-protein Diets	-
A dietary intervention of control diets	Control Diets	-

Primary Outcome Measures

Name	Time	Method
Change in serum levels of indoxyl sulfate, p-Cresyl sulfate and trimethylamine N-Oxide	4 weeks after starting intervention

Secondary Outcome Measures

Name	Time	Method
Change in eGFR	4 weeks after starting intervention
Change in serum bicarbonete levels	4 weeks after starting intervention
Change in serum levels of acetic acid, propionic acid and butyric acid	4 weeks after starting intervention
Change in urinary citrate to creatinine ratio	4 weeks after starting intervention	The measurement of this outcome was abandoned because of the end of sales for its measuring reagent (F-kit citrate; JK International, Tokyo, Japan) in Japan on December 23, 2022. This decision had been made before we initiatited the recruitement of study participants.
Change in blood pressure	4 weeks after starting intervention
Dietary adherence	4 weeks after starting intervention	How many times participants have the study diet during the study period.
Diversity and composition of the gut microbiota	4 weeks after starting intervention
Change in muscle mass	4 weeks after starting intervention
Change in urinary protein creatinine ratio	4 weeks after starting intervention
Change in serum levels of calcium, phosphate, intact parathyroid hormone and intact fibroblast growth factor 23	4 weeks after starting intervention
The number of oral medications including antihypertensive drugs, diuretics, potassium tablets, potassium binders, phosphate binders, calcium tablets, active vitamin D3 analogs and sodium bicarbonate	4 weeks after starting intervention

Trial Locations

Locations (1)

Department of Nephrology, Osaka University; 🇯🇵 Suita, Osaka, Japan