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

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

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

Conditions
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Chronic Kidney Disease Stage 5

Intervention / Treatment
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* Other: Plant-protein Diets
* Other: Control Diets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with chronic kidney disease who were referred to the Outpatient Department of Nephrology at Osaka University Hospital eGFR < 20 mL/min/1.73 m2 taking anigiotensin-converting enzyme inhibitors or angiotensin Ⅱ receptor blockers or angiotensin receptor neprilysin inhibitor 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plant-protein diets, chronic kidney disease, uremic solutes, metabolic acidosis, chronic kidney disease-mineral and bone disorder, gut microbiome