UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000058908 |
|---|---|
| Receipt number | R000067265 |
| Scientific Title | An investigation on the effect of glucosamine intake on gut environments - A double-blind crossover placebo-controlled study - |
| Date of disclosure of the study information | 2025/12/07 |
| Last modified on | 2025/08/27 13:06:20 |
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Basic information
Public title
An investigation on the effect of glucosamine intake on gut environments
Acronym
Effect of glucosamine on gut environments
Scientific Title
An investigation on the effect of glucosamine intake on gut environments - A double-blind crossover placebo-controlled study -
Scientific Title:Acronym
Effect of glucosamine on gut environments - A double-blind crossover placebo-controlled study -
Region
| Japan |
Condition
Condition
Constipation tendency in adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of glucosamine intake on improving the intestinal environment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut environment parameters
Key secondary outcomes
Blood biochemistry parameters
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of glucosamine 3000mg per day for 14 days
Interventions/Control_2
Intake of placebo 3000mg per day for 14 days
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese men and women aged 20 to 59 years at the time of consent.
2) Individuals capable of consistently taking 10 or more supplement tablets per day (can be divided into multiple doses).
3) Individuals with a bowel movement frequency of 3 to 5 times per week.
4) Individuals able to store stool samples collected at home in their refrigerator or freezer for several days until their visit.
Key exclusion criteria
1) Individuals with alcohol dependency
2) Individuals taking medications that may influence the study results (e.g., drugs with intestinal regulatory effects, antibiotics, etc.)
3) Individuals routinely consuming health foods that may affect the study results (e.g., supplements containing lactic acid bacteria, oligosaccharides, or those claiming intestinal regulatory effects)
4) Individuals with potential allergy symptoms to test product components (especially shrimp or crab)
5) Individuals participating in other clinical trials
6) Individuals with a history of severe liver, kidney, or heart disease
7) Individuals with a history or current diagnosis of hepatitis
8) Individuals with a history or current diagnosis of diabetes
9) Individuals with a history or current diagnosis of thrombosis
10) Individuals with severe anemia
11) Pregnant women, women who may be pregnant, and breastfeeding women
Target sample size
40
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
072-740-3300
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
SOUKEN Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
TOYO INSTITUTE of FOOD TECHNOLOGY
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Institutional Review Board
Address
1-9-10, DaiwaA Hamamatsucho Building 3rd floor, Hamamatsucho, Minato-ku, Tokyo, Japan
Tel
03-5408-1555
jimukyoku@mail.souken-r.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 | 12 | 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
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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2025 | Year | 08 | Month | 27 | Day |
Last modified on
| 2025 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067265
