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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Kidney Disease Stage 5
• Intervention / Treatment: Other: Plant-protein Diets; Other: Control Diets

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Osaka
    • Suita, Osaka, Japan, 5650871
      • Department of Nephrology, Osaka University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A dietary intervention of plant-protein based diets	Other: Plant-protein Diets; 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.
Active Comparator: A dietary intervention of control diets	Other: Control Diets; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in eGFR		4 weeks after starting intervention
Change in urinary protein creatinine ratio		4 weeks after starting intervention
Change in serum bicarbonete levels		4 weeks after starting intervention
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.	4 weeks after starting intervention
Change in blood pressure		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
Change in serum levels of acetic acid, propionic acid and butyric acid		4 weeks after starting intervention
Diversity and composition of the gut microbiota		4 weeks after starting intervention
Change in muscle mass		4 weeks after starting intervention
Dietary adherence	How many times participants have the study diet during the study period.	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

Collaborators and Investigators

• Sponsor: Osaka University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: chronic kidney disease; gut microbiome; metabolic acidosis; plant-protein diets; uremic solutes; chronic kidney disease-mineral and bone disorder
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 21371

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No