Efficacy of Plant-protein Diets in Patients With Chronic Kidney Disease
Primary Purpose
Chronic Kidney Disease Stage 5
Status
Recruiting
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Plant-protein Diets
Control Diets
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease Stage 5 focused on measuring plant-protein diets, chronic kidney disease, uremic solutes, metabolic acidosis, chronic kidney disease-mineral and bone disorder, gut microbiome
Eligibility Criteria
Inclusion Criteria:
- patients with chronic kidney disease who were referred to the Outpatient Department of Nephrology at Osaka University Hospital
- eGFR < 15 mL/min/1.73 m2
- taking anigiotensin-converting enzyme inhibitors or angiotensin Ⅱ receptors
- K < 5.5 mEq/L
Exclusion Criteria:
- Being planned to intitate renal replacement therapies within 3 months
- Having inflammatory bowel diseases
- History of gastrointestinal tract surgery
- Taking antibiotics within 1 month before the entry
- Taking or being planned to start warfarin
- Having dietary allergies
- Having difficulty in oral intake
- During pregnancy or breastfeeding
- Unsuitable for participant in the trial by an attending physician
Sites / Locations
- Department of Nephrology, Osaka UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A dietary intervention of plant-protein based diets
A dietary intervention of control diets
Arm Description
Outcomes
Primary Outcome Measures
Change in serum levels of indoxyl sulfate, p-Cresyl sulfate and trimethylamine N-Oxide
Secondary Outcome Measures
Change in eGFR
Change in urinary protein creatinine ratio
Change in serum bicarbonete levels
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.
Change in blood pressure
Change in serum levels of calcium, phosphate, intact parathyroid hormone and intact fibroblast growth factor 23
Change in serum levels of acetic acid, propionic acid and butyric acid
Diversity and composition of the gut microbiota
Change in muscle mass
Dietary adherence
How many times participants have the study diet during the study period.
The number of oral medications including antihypertensive drugs, diuretics, potassium tablets, potassium binders, phosphate binders, calcium tablets, active vitamin D3 analogs and sodium bicarbonate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05350098
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Osaka University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A dietary intervention of plant-protein based diets
Arm Type
Experimental
Arm Title
A dietary intervention of control diets
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Plant-protein Diets
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Diets
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in serum levels of indoxyl sulfate, p-Cresyl sulfate and trimethylamine N-Oxide
Time Frame
4 weeks after starting intervention
Secondary Outcome Measure Information:
Title
Change in eGFR
Time Frame
4 weeks after starting intervention
Title
Change in urinary protein creatinine ratio
Time Frame
4 weeks after starting intervention
Title
Change in serum bicarbonete levels
Time Frame
4 weeks after starting intervention
Title
Change in urinary citrate to creatinine ratio
Description
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
Title
Change in blood pressure
Time Frame
4 weeks after starting intervention
Title
Change in serum levels of calcium, phosphate, intact parathyroid hormone and intact fibroblast growth factor 23
Time Frame
4 weeks after starting intervention
Title
Change in serum levels of acetic acid, propionic acid and butyric acid
Time Frame
4 weeks after starting intervention
Title
Diversity and composition of the gut microbiota
Time Frame
4 weeks after starting intervention
Title
Change in muscle mass
Time Frame
4 weeks after starting intervention
Title
Dietary adherence
Description
How many times participants have the study diet during the study period.
Time Frame
4 weeks after starting intervention
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with chronic kidney disease who were referred to the Outpatient Department of Nephrology at Osaka University Hospital
eGFR < 20 mL/min/1.73 m2
taking anigiotensin-converting enzyme inhibitors or angiotensin Ⅱ receptor blockers or angiotensin receptor neprilysin inhibitor
K < 5.5 mEq/L
Exclusion Criteria:
Being planned to intitate renal replacement therapies within 3 months
Having inflammatory bowel diseases
History of gastrointestinal tract surgery
Taking antibiotics within 1 month before the entry
Taking or being planned to start warfarin
Having dietary allergies
Having difficulty in oral intake
During pregnancy or breastfeeding
Unsuitable for participant in the trial by an attending physician
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yusuke Sakaguchi, MD, PhD
Phone
+81-6-6879-3747
Email
sakaguchi@kid.med.osaka-u.ac.jp
Facility Information:
Facility Name
Department of Nephrology, Osaka University
City
Suita
State/Province
Osaka
ZIP/Postal Code
5650871
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yusuke Sakaguchi, MD, PhD
Email
sakaguchi@kid.med.osaka-u.ac.jp
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Plant-protein Diets in Patients With Chronic Kidney Disease
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