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

Primary Purpose

Chronic Kidney Disease Stage 5

Status

Recruiting

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

Plant-protein Diets

Control Diets

About this trial

This is an interventional treatment trial for Chronic Kidney Disease Stage 5 focused on measuring plant-protein diets, chronic kidney disease, uremic solutes, metabolic acidosis, chronic kidney disease-mineral and bone disorder, gut microbiome

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients with chronic kidney disease who were referred to the Outpatient Department of Nephrology at Osaka University Hospital
eGFR < 15 mL/min/1.73 m2
taking anigiotensin-converting enzyme inhibitors or angiotensin Ⅱ receptors
K < 5.5 mEq/L

Exclusion Criteria:

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

Sites / Locations

Department of Nephrology, Osaka UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A dietary intervention of plant-protein based diets

A dietary intervention of control diets

Arm Description

Outcomes

Primary Outcome Measures

Change in serum levels of indoxyl sulfate, p-Cresyl sulfate and trimethylamine N-Oxide

Secondary Outcome Measures

Change in eGFR

Change in urinary protein creatinine ratio

Change in serum bicarbonete levels

Change in urinary citrate to creatinine ratio

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

Change in serum levels of calcium, phosphate, intact parathyroid hormone and intact fibroblast growth factor 23

Change in serum levels of acetic acid, propionic acid and butyric acid

Diversity and composition of the gut microbiota

Change in muscle mass

Dietary adherence

How many times participants have the study diet during the study period.

The number of oral medications including antihypertensive drugs, diuretics, potassium tablets, potassium binders, phosphate binders, calcium tablets, active vitamin D3 analogs and sodium bicarbonate

Full Information

NCT ID

NCT05350098

First Posted

April 6, 2022

Last Updated

February 14, 2023

Sponsor

Osaka University

1. Study Identification

Unique Protocol Identification Number

NCT05350098

Brief Title

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

Official Title

A Randomized Controlled Trial to Evaluate the Efficacy of Plant-protein Diets in Patients With Chronic Kidney Disease: a Pilot-study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2023 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Osaka University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease Stage 5

Keywords

plant-protein diets, chronic kidney disease, uremic solutes, metabolic acidosis, chronic kidney disease-mineral and bone disorder, gut microbiome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

A dietary intervention of plant-protein based diets

Arm Type

Experimental

Arm Title

A dietary intervention of control diets

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Plant-protein Diets

Intervention Description

Participants will consume meals with 70% plant-based protein three times a day. Participants will be prohibited to have meals other than experimental diets and to drink milk and soy milk.

Intervention Type

Other

Intervention Name(s)

Control Diets

Intervention Description

Participants will consume meals with 50% plant-based protein three times a day. Participants will be prohibited to have meals other than experimental diets and to drink milk and soy milk.

Primary Outcome Measure Information:

Title

Change in serum levels of indoxyl sulfate, p-Cresyl sulfate and trimethylamine N-Oxide

Time Frame