Clinical trial NCT05350098: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Osaka University
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in serum levels of indoxyl sulfate, p-Cresyl sulfate and trimethylamine N-Oxide
timeFrame: 4 weeks after starting intervention
Secondary outcomes:
measure: Change in eGFR
timeFrame: 4 weeks after starting intervention
measure: Change in urinary protein creatinine ratio
timeFrame: 4 weeks after starting intervention
measure: Change in serum bicarbonete levels
timeFrame: 4 weeks after starting intervention
measure: Change in urinary citrate to creatinine ratio
timeFrame: 4 weeks after starting intervention
measure: Change in blood pressure
timeFrame: 4 weeks after starting intervention
measure: Change in serum levels of calcium, phosphate, intact parathyroid hormone and intact fibroblast growth factor 23
timeFrame: 4 weeks after starting intervention
measure: Change in serum levels of acetic acid, propionic acid and butyric acid
timeFrame: 4 weeks after starting intervention
measure: Diversity and composition of the gut microbiota
timeFrame: 4 weeks after starting intervention
measure: Change in muscle mass
timeFrame: 4 weeks after starting intervention
measure: Dietary adherence
timeFrame: 4 weeks after starting intervention
measure: The number of oral medications including antihypertensive drugs, diuretics, potassium tablets, potassium binders, phosphate binders, calcium tablets, active vitamin D3 analogs and sodium bicarbonate
timeFrame: 4 weeks after starting intervention
Other outcomes:
Locations:
city: Suita
country: Japan
facility: Department of Nephrology, Osaka University
state: Osaka
Study officials:
References: