UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058208 |
|---|---|
| Receipt number | R000066527 |
| Scientific Title | Epidemiological Study on Gut Microbiota in Daily Glucosamine Consumers: An Exploratory Investigation through a Cross-Sectional Study |
| Date of disclosure of the study information | 2025/06/30 |
| Last modified on | 2025/06/18 17:12:41 |
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Basic information
Public title
Epidemiological Investigation of Gut Microbiota in Daily Glucosamine Consumers
Acronym
Investigation of Gut Microbiota in Glucosamine Consumers
Scientific Title
Epidemiological Study on Gut Microbiota in Daily Glucosamine Consumers: An Exploratory Investigation through a Cross-Sectional Study
Scientific Title:Acronym
Study on Gut Microbiota in Glucosamine Consumers: An Exploratory Cross-Sectional Study
Region
| Japan |
Condition
Condition
Healthy Individuals
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate how the gut microbiota differs between glucosamine product consumers and non-consumers in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diversity of bacteria in the gut microbiota, the increase or decrease of specific bacteria, and changes in microbiota analysis outcomes
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 50 | years-old | <= |
Age-upper limit
| 59 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Daily Glucosamine Consumers
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Shintani |
Organization
Toyo Institute of Food Technology
Division name
Research department
Zip code
666-0026
Address
4-23-2 Minami-Hanayashiki, Kawanishi, Hyogo 666-0026, Japan
TEL
08072169232
tomoya_shintani@shokuken.or.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Shintani |
Organization
TOYO INSTITUTE of FOOD TECHNOLOGY
Division name
Research department
Zip code
666-0026
Address
4-23-2 Minami-Hanayashiki, Kawanishi, Hyogo 666-0026, Japan
TEL
08072169232
Homepage URL
tomoya_shintani@shokuken.or.jp
Sponsor or person
Institute
Toyo Institute of Food Technology
Institute
Department
Personal name
Tomoya Shintani
Funding Source
Organization
Toyo Institute of Food Technology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyo Institute of Food Technology
Address
4-23-2, Minami-hanayashiki, Kawanishi, Hyogo
Tel
08072169232
tomoya_shintani@shokuken.or.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
Hyogo
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 30 | 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
200
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Background of the Data Used]
The data for this study were obtained from a commercial database provided by a gut flora testing service company in Japan.
This database includes gut microbiota data from participants, along with basic attributes (gender, age group, BMI category) and lifestyle information collected via a questionnaire.
[Participant Criteria]
The study included 100 individuals who habitually use glucosamine products.
Participants were aged 50-59 years.
[Data Collection]
A "habitual glucosamine product user" (glucosamine user) was defined as someone who answered "yes" to the question, "Have you regularly used supplements at least 4 days a week for the past month or more?" and wrote "glucosamine" in the free-response field for supplements.
An employee of the gut flora company extracted data for individuals meeting the study criteria from the database.
A total of 100 glucosamine users (50 males, 50 females, aged 50-59 years) were identified. Non-users (controls) were also extracted, matched to users by gender and age group.
Thus, 200 individuals (100 glucosamine users, 100 non-users) were included.
Data extraction and participant selection were conducted independently by a company employee, blinded to the researchers.
The researchers received anonymized data, including gut microbiota data, basic attributes (gender, age group, BMI category), and lifestyle data (glucosamine usage).
[Data Analysis]
Gut microbiota analysis pipelines, statistical software, and programming languages were used to examine the relationship between glucosamine intake, BMI, and gut microbiota characteristics.
[Data Availability]
The 16S rRNA sequencing data, basic attributes (gender, age group, BMI category), and lifestyle data (glucosamine usage)(Anonymously processed information, respectively) will be registered in the DNA Data Bank of Japan (DDBJ).
Management information
Registered date
| 2025 | Year | 06 | Month | 18 | Day |
Last modified on
| 2025 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066527
