Sake lees dietary therapy for chronic kidney disease patients: Pilot randomized controlled trial

Not Applicable

Recruiting

• Conditions: Chronic kidney disease

• Registration Number: JPRN-jRCT1040220095
• Lead Sponsor: Tokumaru Toshiaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1) Patients attending the outpatient department of nephrology at Kanazawa University Hospital
2) Patients whose most recent eGFR within 3 months prior to enrollment was between 15 mL/min/1.73 m2 and 59 mL/min/1.73 m2
3) Patients who meet the diagnostic criteria for chronic kidney disease
4) Patients whose age at the time of consent is 20 years or older
5) Patients whose performance status (ECOG) at the time of consent is 0
6) Patients who have given their free written consent to participate in this clinical trial after obtaining sufficient informed consent

Exclusion Criteria

1) Patients on dialysis therapy
2) Patients after renal transplantation
3) Patients with cancer
4) Patients with Body Mass Index less than 16
5) Patients with primary and secondary immunodeficiency
6) Patients with inflammatory bowel disease
7) Patients with hepatic impairment or hepatic dysfunction
8) Patients who routinely take antibacterial drugs
9) Patients who routinely consume sake lees
10) Patients with alcohol intolerance
11) Patients with a history of antimicrobial use within the past 4 weeks from the time of study entry
12) Patients with a history of alcohol dependence
13) Patients who are deemed by the physician to be inappropriate to participate in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amount of change in blood indoxyl sulfate concentration before and 8 weeks after intake of sake lees.

Secondary Outcome Measures

Name	Time	Method
Blood p-cresyl sulfate concentration<br>Blood D-serine and D-alanine concentrations<br>Fecal uremic substance concentration<br>Fecal short-chain fatty acid concentration<br>Fecal pH <br>Fecal D-serine and D-alanine concentrations<br>Metagenomic analysis of fecal flora<br>Constipation score (CSS)<br>Constipation and quality of life score (PAC-QOL)<br>Urinary protein/creatinine ratio<br>Urinary MCP-1 and KIM-1 levels<br>Daily salt intake estimated from spot urine<br>Urinary pH