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Clinical Trials/NCT05350098
NCT05350098Active, not recruitingNot Applicable

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

Osaka University1 site in 1 country40 target enrollmentStarted: January 1, 2023Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
40
Locations
1
Primary Endpoint
Change in serum levels of indoxyl sulfate, p-Cresyl sulfate and trimethylamine N-Oxide
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

A dietary intervention of plant-protein based diets

Experimental

Intervention: Plant-protein Diets (Other)

A dietary intervention of control diets

Active Comparator

Intervention: Control Diets (Other)

Outcomes

Primary Outcomes

Change in serum levels of indoxyl sulfate, p-Cresyl sulfate and trimethylamine N-Oxide

Time Frame: 4 weeks after starting intervention

Secondary Outcomes

  • Change in eGFR(4 weeks after starting intervention)
  • Change in serum bicarbonete levels(4 weeks after starting intervention)
  • Change in serum levels of acetic acid, propionic acid and butyric acid(4 weeks after starting intervention)
  • Change in urinary citrate to creatinine ratio(4 weeks after starting intervention)
  • Change in blood pressure(4 weeks after starting intervention)
  • Dietary adherence(4 weeks after starting intervention)
  • Diversity and composition of the gut microbiota(4 weeks after starting intervention)
  • Change in muscle mass(4 weeks after starting intervention)
  • Change in urinary protein creatinine ratio(4 weeks after starting intervention)
  • Change in serum levels of calcium, phosphate, intact parathyroid hormone and intact fibroblast growth factor 23(4 weeks after starting intervention)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yusuke Sakaguchi

assistant professor

Osaka University

Study Sites (1)

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