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

Chronic Kidney Disease Stage 5 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05350098
• Other study ID #: 21371
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: October 2023
• Source: Osaka University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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 ? 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

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 5
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Plant-protein Diets
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.
• Control Diets
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.

Locations

Country	Name	City	State
Japan	Department of Nephrology, Osaka University	Suita	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Osaka University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum levels of indoxyl sulfate, p-Cresyl sulfate and trimethylamine N-Oxide		4 weeks after starting intervention
Secondary	Change in eGFR		4 weeks after starting intervention
Secondary	Change in urinary protein creatinine ratio		4 weeks after starting intervention
Secondary	Change in serum bicarbonete levels		4 weeks after starting intervention
Secondary	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
Secondary	Change in blood pressure		4 weeks after starting intervention
Secondary	Change in serum levels of calcium, phosphate, intact parathyroid hormone and intact fibroblast growth factor 23		4 weeks after starting intervention
Secondary	Change in serum levels of acetic acid, propionic acid and butyric acid		4 weeks after starting intervention
Secondary	Diversity and composition of the gut microbiota		4 weeks after starting intervention
Secondary	Change in muscle mass		4 weeks after starting intervention
Secondary	Dietary adherence	How many times participants have the study diet during the study period.	4 weeks after starting intervention
Secondary	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