A Randomized Controlled Trial to Evaluate the Efficacy of plant-protein diets in Patients with Chronic Kidney Disease: a pilot-study

A Randomized Controlled Trial to Evaluate the Efficacy of plant-protein diets in Patients with Chronic Kidney Disease: a pilot-study - A Randomized Controlled Trial to Evaluate the Efficacy of plant-protein diets in Patients with Chronic Kidney Disease: a pilot-study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000047150

Enrollment

Registered

2022-03-11

Start date

2022-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic kidney disease

Interventions

plant-protein diets control diets

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Change in serum levels of indoxyl sulfate, p-Cresyl sulfate and trimethylamine N-Oxide	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactYusuke Sakaguchi

Osaka University Graduate School of Medicine Department of Inter-Organ Communication Research in Kidney Diseases

sakaguchi@kid.med.osaka-u.ac.jp06-6879-3747

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026