UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056444 |
|---|---|
| Receipt number | R000064472 |
| Scientific Title | Effects of sake lees intake on fecal uremic toxins, plasma D-alanine, constipation, and gut microbiome in healthy adults |
| Date of disclosure of the study information | 2024/12/18 |
| Last modified on | 2024/12/13 05:21:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of sake lees intake on fecal uremic toxins, plasma D-alanine, constipation, and gut microbiome in healthy adults
Acronym
Sake lees and their impact on uremic toxins and gut health
Scientific Title
Effects of sake lees intake on fecal uremic toxins, plasma D-alanine, constipation, and gut microbiome in healthy adults
Scientific Title:Acronym
Sake lees and their impact on uremic toxins and gut health
Region
| Japan |
Condition
Condition
Chronic constipation
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sake lees consumption has the potential to reduce uremic toxins by influencing the gut microbiome. To lay the groundwork for a clinical trial targeting chronic kidney disease patients, we conducted a pilot study to explore the relationship between sake lees intake and changes in fecal uremic toxin levels among individuals with constipation. D-alanine, a renoprotective component of sake lees, was also evaluated.
Basic objectives2
Others
Basic objectives -Others
Based on the results of this study, we will set the amount of sake lees intake and the duration of intake in a small-scale randomised controlled trial targeting patients with chronic kidney disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in fecal uremic toxins (indole and cresol)
Key secondary outcomes
Changes in plasma D-alanine, constipation, and gut microbiome
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake 25g of sake lees or 50g of sake lees per day for 6 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants were eligible if they were aged 20 years or older and met the diagnostic criteria for chronic constipation.
Key exclusion criteria
Exclusion criteria included alcohol intolerance, antibiotic use within the previous 4 weeks, or use of medications causing diarrhea or constipation.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Tokumaru |
Organization
Kanazawa University Hospital
Division name
Department of Nutrition Management
Zip code
920-8641
Address
Takara-machi 13-1, Kanazawa-shi 920-8641, Japan
TEL
0762652087
tkmr-knz@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiaki |
| Middle name | |
| Last name | Tokumaru |
Organization
Kanazawa University Hospital
Division name
Department of Nutrition Management
Zip code
920-8641
Address
Takara-machi 13-1, Kanazawa-shi 920-8641, Japan
TEL
0762652087
Homepage URL
tkmr-knz@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanazawa University Medical Ethics Review Committee
Address
Takara-machi 13-1, Kanazawa-shi 920-8641, Japan
Tel
0762652110
rinri@adm.kanazawa-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 18 | Day |
Related information
URL releasing protocol
https://jsn.or.jp/general/congress/journal/66_4.pdf
Publication of results
Unpublished
Result
URL related to results and publications
https://jsn.or.jp/general/congress/journal/66_4.pdf
Number of participants that the trial has enrolled
8
Results
Eight participants, with a mean age of 46 years, completed the study. Percentage changes in fecal indole levels were +42%, +52%, and -6% at weeks 2, 4, and 6, respectively. Plasma D-alanine levels showed percentage changes of +39%, +24%, and +38% at the same time points. CSS scores improved from 9.2 to 6.8 by week 2 and remained stable after week 4. The proportion of the phylum Firmicutes in the gut microbiome increased slightly, from 53% at baseline to 57% by week 6.
Results date posted
| 2024 | Year | 12 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The average age was 46 years, with 75% of participants being women. The average levels of fecal indole and p-cresol were 45 ug/g and 130 ug/g, respectively. The mean plasma D-alanine and D-serine levels were 0.89 nmol/mL and 2.22 nmol/mL, respectively. The mean Constipation Scoring System score was 9.3 and the average Patient Assessment of Constipation Quality of Life score was 43.
Participant flow
Eight participants who met the inclusion criteria were enrolled in the study. After randomization, four participants were assigned to consume either 25 g/day or 50 g/day of sake lees. All participants completed both the run-in and sake lees intake periods without any protocol violations.
Adverse events
No adverse events were observed in the participants.
Outcome measures
The primary endpoints were the percentage changes in fecal indole and p-cresol levels from baseline.
Secondary endpoints were the percentage changes in plasma D-alanine and D-serine levels, the Constipation Scoring System score, the Patient Assessment of Constipation Quality of Life score, the fecal microbiome composition at the phylum level, the proportion of Bacteroides (indole-producing bacteria), and the proportion of Coriobacteriaceae (p-cresol-producing bacteria), alpha diversity (number of operational taxonomic units [OTUs], Chao-1 index, and Shannon index), beta diversity (unweighted and weighted UniFrac distance), and adherence to sake lees intake.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 13 | Day |
Last modified on
| 2024 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064472
