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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
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.
Department of Nephrology, Osaka University
Suita, Osaka, Japan
Change in serum levels of indoxyl sulfate, p-Cresyl sulfate and trimethylamine N-Oxide
Time frame: 4 weeks after starting intervention
Change in eGFR
Time frame: 4 weeks after starting intervention
Change in urinary protein creatinine ratio
Time frame: 4 weeks after starting intervention
Change in serum bicarbonete levels
Time frame: 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.
Time frame: 4 weeks after starting intervention
Change in blood pressure
Time frame: 4 weeks after starting intervention
Change in serum levels of calcium, phosphate, intact parathyroid hormone and intact fibroblast growth factor 23
Time frame: 4 weeks after starting intervention
Change in serum levels of acetic acid, propionic acid and butyric acid
Time frame: 4 weeks after starting intervention
Diversity and composition of the gut microbiota
Time frame: 4 weeks after starting intervention
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Change in muscle mass
Time frame: 4 weeks after starting intervention
Dietary adherence
How many times participants have the study diet during the study period.
Time frame: 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
Time frame: 4 weeks after starting intervention