UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062791 |
|---|---|
| Receipt number | R000071877 |
| Scientific Title | An Exploratory Study of Gut Microbiota Associated with Lipid Metabolism in Healthy Adults |
| Date of disclosure of the study information | 2026/09/02 |
| Last modified on | 2026/09/02 18:15:39 |
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Basic information
Public title
An Exploratory Study of Gut Microbiota Associated with Lipid Metabolism in Healthy Adults
Acronym
An Exploratory Study of Gut Microbiota Associated with Lipid Metabolism
Scientific Title
An Exploratory Study of Gut Microbiota Associated with Lipid Metabolism in Healthy Adults
Scientific Title:Acronym
An Exploratory Study of Gut Microbiota Associated with Lipid Metabolism
Region
| Japan |
Condition
Condition
NA
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Fecal samples collected from healthy adults will be cultured in media supplemented with lipid components to explore and isolate gut bacteria potentially associated with lipid components. In addition fecal microbiome analysis will be performed to obtain baseline data on the gut microbial environment of the participants.
Basic objectives2
Others
Basic objectives -Others
Exploratory basic research on gut bacteria
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility of culturing and isolating target bacteria using media supplemented with lipid components
Key secondary outcomes
Fecal microbiome profile (e.g., diversity indices and microbial community composition)
Fecal metabolite profile
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese men and women aged 18 years or older and under 65 years at the time of written informed consent
2. Individuals who fully understand the objectives and details of the study and voluntarily provide written informed consent to participate
Key exclusion criteria
1. Diagnosis of constipation or a disease considered likely to significantly affect bowel movements
2. Current medication or outpatient treatment for any serious disease
3. Current exercise or dietary therapy under medical supervision
4. Current or past history of drug or alcohol dependence
5. Current outpatient treatment for a psychiatric or sleep disorder or a history of psychiatric disease
6. Irregular daily routines due to night work or shift work
7. Extremely irregular eating sleeping or other lifestyle habits
8. Extremely unbalanced dietary habits
9. Average pure alcohol intake of approximately 60 g or more per day or smoking 21 or more cigarettes per day
10. Current or past history of a serious brain malignant immune diabetic liver kidney cardiac thyroid adrenal or other metabolic disease
11. Current or planned use of antibiotics or other medications that may affect the gut microbiota
12. Overseas travel long term business travel or another event causing a substantial change in dietary habits within one month before informed consent
13. Participation in another clinical trial or study within three months before informed consent or planned participation during the study period
14. Current pregnancy or breastfeeding or the possibility of pregnancy during the study period
15. Difficulty complying with questionnaire recording requirements
16. Considered unsuitable based on clinical laboratory test results or questionnaire responses at screening
17. Otherwise considered unsuitable by the investigator responsible for the study site
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Motoki |
| Middle name | |
| Last name | Miyakita |
Organization
The Nisshin OilliO Group, Ltd.
Division name
Technical Division Strategic invention R&D
Zip code
2358558
Address
1 Shinmori-cho, Isogo-ku, Yokohama, Kanagawa, Japan
TEL
0457575461
m-miyakita@nisshin-oillio.com
Public contact
Name of contact person
| 1st name | Motoki |
| Middle name | |
| Last name | Miyakita |
Organization
The Nisshin OilliO Group, Ltd.
Division name
Technical Division Strategic invention R&D
Zip code
2358558
Address
1 Shinmori-cho, Isogo-ku, Yokohama, Kanagawa, Japan
TEL
0457575461
Homepage URL
m-miyakita@nisshin-oillio.com
Sponsor or person
Institute
The Nisshin OilliO Group, Ltd.
Institute
Department
Personal name
Funding Source
Organization
The Nisshin OilliO Group, Ltd.
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
Medical Corporation DiaStep Ouchinodoctor Research Ethics Committee
Address
Morizumi Bldg. 3F, 4-22-7 Taishido, Setagaya-ku, Tokyo, Japan
Tel
0354333255
tomohisa.kato@diastep.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
| 2026 | Year | 09 | Month | 02 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study involving healthy adults Individuals who voluntarily apply for participation and meet the inclusion criteria do not meet any of the exclusion criteria and are considered able to comply with the study requirements will be enrolled. Fecal samples collected from the participants will be used to evaluate the feasibility of culturing and isolating target bacteria using media supplemented with lipid components as well as fecal microbiome profiles and fecal metabolite profiles. No intervention will be administered to the participants.
Management information
Registered date
| 2026 | Year | 09 | Month | 02 | Day |
Last modified on
| 2026 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071877
