A Randomized Controlled Trial to Evaluate the Efficacy of plant-protein diets in Patients with Chronic Kidney Disease: a pilot-study
Not Applicable
- Conditions
- chronic kidney disease
- Registration Number
- JPRN-UMIN000047150
- Lead Sponsor
- Osaka University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
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 & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in serum levels of indoxyl sulfate, p-Cresyl sulfate and trimethylamine N-Oxide
- Secondary Outcome Measures
Name Time Method 1) Change in eGFR and urinary protein creatinine ratio 2) Change in serum bicarbonate levels 3) Change in systolic and diastolic blood pressure 4) Change in serum levels of calcium, phosphate, intact parathyroid hormone and intact fibroblast growth factor 23 5) Change in serum levels of acetic acid, propionic acid and butyric acid 6) Change in gut microbiome composition 7) Change in muscle strength 8) Dietary adherence 9) Oral medications including antihypertensive drugs, diuretics, potassium tablets, potassium binders, phosphate binders, calcium tablets, active vitamin D3 analogs and sodium bicarbonate