NCT05350098

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

April 6, 2022

Last Update Submit

October 30, 2023

Conditions

Chronic Kidney Disease Stage 5

Keywords

plant-protein dietschronic kidney diseaseuremic solutesmetabolic acidosischronic kidney disease-mineral and bone disordergut microbiome

Outcome Measures

Primary Outcomes (1)

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

    4 weeks after starting intervention

Secondary Outcomes (11)

  • Change in eGFR

    4 weeks after starting intervention

  • Change in urinary protein creatinine ratio

    4 weeks after starting intervention

  • Change in serum bicarbonete levels

    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

  • +6 more secondary outcomes

Study Arms (2)

A dietary intervention of plant-protein based diets

EXPERIMENTAL
Other: Plant-protein Diets

A dietary intervention of control diets

ACTIVE COMPARATOR
Other: Control Diets

Interventions

Plant-protein DietsOTHER

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.

A dietary intervention of plant-protein based diets
Control DietsOTHER

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.

A dietary intervention of control diets

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 â…¡ receptor blockers or angiotensin receptor neprilysin inhibitor
  • K \< 5.5 mEq/L

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrology, Osaka University

Suita, Osaka, 5650871, Japan

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicAcidosisChronic Kidney Disease-Mineral and Bone Disorder

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesRicketsBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesCalcium Metabolism DisordersVitamin D DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersHyperparathyroidism, SecondaryHyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

April 6, 2022

First Posted

April 27, 2022

Study Start

January 1, 2023

Primary Completion

March 30, 2024

Study Completion

March 30, 2024

Last Updated

November 1, 2023

Record last verified: 2023-10

Locations

JP(1)