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

A study to ascertain changes in blood urimic toxins in chronic kidney disease patients due to dietary treatment with sake lees: Open-label pilot randomized controlled trial - Sake lees CKD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1040220095
Enrollment
24
Registered
2022-11-22
Start date
2022-12-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease Chronic kidney disease

Interventions

The patient is required to follow a normal chronic kidny disease dietary treatment with the addition of 50 g of sake lees per day for 8 weeks.
Sake lees

Sponsors

Tokumaru Toshiaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Amount of change in blood indoxyl sulfate concentration before and 8 weeks after intake of sake lees.

Secondary

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

Contacts

Public ContactToshiaki Tokumaru

Kanazawa University Hospita

tkmr-knz@staff.kanazawa-u.ac.jp+81-76-265-2087

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026