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

JRCT ID: jRCT1040220095

Registered date:22/11/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Chronic kidney disease
• Date of first enrollment: 22/11/2022
• Target sample size: 24
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Amount of change in blood indoxyl sulfate concentration before and 8 weeks after intake of sake lees.

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Tokumaru Toshiaki