UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056757 |
|---|---|
| Receipt number | R000064864 |
| Scientific Title | An investigation on the effect of glucosamine intake on improving bowel movements -Open Label Single Arm Trial- |
| Date of disclosure of the study information | 2025/02/10 |
| Last modified on | 2025/01/22 11:22:33 |
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Basic information
Public title
An investigation on the effect of glucosamine intake on improving bowel movements
Acronym
Effect of glucosamine on improving bowel movements
Scientific Title
An investigation on the effect of glucosamine intake on improving bowel movements -Open Label Single Arm Trial-
Scientific Title:Acronym
Effect of glucosamine on improving bowel movements -Single Arm Trial-
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
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bowel movements (the previous observation period (2 weeks) and the 2 weeks-intake period after starting intake)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of glucosamine 1500mg per day for 14 days
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese men and women aged 20 to 59 at the time of consent
2) Subjects with a bowel movement frequency of 3 to 5 times per week
Key exclusion criteria
1) Those taking medicines that may affect the test results (medicines with intestinal regulating effects, antibiotics, etc.)
2) Those who regularly consume health foods that may affect the test results (lactic acid bacteria, oligosaccharides, supplements that claim to regulate the intestines, etc.) or health foods that contain the same main ingredients as the test product
3) Pregnant or potentially pregnant women, and breastfeeding women
4) Those with alcoholism
5) Those who may have allergic reactions to the test product ingredients
6) Those participating in other clinical trials
7) Those with a history of severe liver damage, kidney damage, or heart disease
8) Those with a history of hepatitis or current illness
9) Those with severe anemia
Target sample size
20
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
072-740-3300
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
Non profit foundation
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 | 02 | Month | 10 | 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
| 2025 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2025 | 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
| 2025 | Year | 01 | Month | 20 | Day |
Last modified on
| 2025 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064864
