UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056648 |
|---|---|
| Receipt number | R000064747 |
| Scientific Title | The effect of fats-coating sodium acetate on the gut environment |
| Date of disclosure of the study information | 2025/01/07 |
| Last modified on | 2026/01/15 10:07:32 |
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Basic information
Public title
The effect of fats-coating sodium acetate on the gut environment
Acronym
The effect of fats-coating sodium acetate on the gut environment
Scientific Title
The effect of fats-coating sodium acetate on the gut environment
Scientific Title:Acronym
The effect of fats-coating sodium acetate on the gut environment
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of taking a fats-coated sodium acetate supplement for two weeks on the gut environment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of butyric acid-producing bacteria before and after 2 weeks of intake
Key secondary outcomes
Fecal physical and chemical test (moisture, pH, IgA, organic acids)
bowel habits
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food for 2 weeks
Interventions/Control_2
Intake of placebo for 2 weeks
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects aged 20 to 60 at the time of obtaining consent
2. Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
3. Subjects who have not taken any foods for specified health uses, functional foods, dietary supplements, that may affect defecation, or who can maintain the same type and frequency of intake of these products they have been taking up until that point during the study period
Key exclusion criteria
1.Subjects with serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
2.Subjects receiving treatment for a gastrointestinal disease currently or those who have had gastrointestinal surgery
3.Subjects who are suffering from or have a history of a disease that may affect defecation
4.Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for microbiome such as intestinal regulator
5.Subjects who have used antibiotics within the past month
6. Subjects who have had the habit of drinking vinegar (including fruit vinegar, black vinegar, etc.) continuously within the past 3 months
7.Subjects who plan to make significant changes to their lifestyle (e.g., diet, sleep, exercise) during the study period
8. Subjects with smoking habits
9. Subjects with irregular lifestyles due to night shifts
10.Female subjects who are pregnant or lactating, or intending to become pregnant during the study
11.Subjects who took part in another study within 3 months prior to the start of the present study or who is currently taking part in another study
12. Subjects deemed unsuitable by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Isaji |
Organization
NOF CORPORATION
Division name
Functional Foods Division Functional Foods Research Lab.
Zip code
210-0865
Address
3-3 chidoricyo, kawasaki-ku, kawasaki-shi
TEL
044-281-2502
tomoya_isaji@nof.co.jp
Public contact
Name of contact person
| 1st name | Takayoshi |
| Middle name | |
| Last name | Fukushima |
Organization
Cykinso, Inc.
Division name
Science & Operation Division
Zip code
151-0053
Address
1-36-1 Yoyogi, Shibuya-ku
TEL
03-5309-2522
Homepage URL
mykinsoresearch_mq02@cykinso.co.jp
Sponsor or person
Institute
NOF CORPORATION
Institute
Department
Personal name
Funding Source
Organization
NOF CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2025 | Year | 01 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
A randomized, double-blind, placebo-controlled study was conducted on healthy adult men and women aged 20 to 65 years taking the fats-coating sodium acetate supplements for two weeks.
As a result, there was no significant change in the proportion of butyric acid-producing bacteria (3 genera) based on 16S rRNA analysis.
Results date posted
| 2026 | Year | 01 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Male and female aged 20 to 60 years old
Participant flow
Enrollment: 20
Allocation: 20
Analysis: 19
Adverse events
There were no adverse events related to the test or placebo foods.
Outcome measures
The proportion of butyric acid-producing bacteria
Fecal physical and chemical test (moisture, pH, IgA, organic acids)
bowel habits
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 04 | Month | 14 | Day |
Date analysis concluded
| 2025 | Year | 06 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 07 | Day |
Last modified on
| 2026 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064747
