UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058686 |
|---|---|
| Receipt number | R000065151 |
| Scientific Title | Elucidation of the mechanism of action of intestinal bacteria on fatness and thinness |
| Date of disclosure of the study information | 2025/08/10 |
| Last modified on | 2025/08/04 10:40:36 |
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Basic information
Public title
Elucidation of the mechanism of action of intestinal bacteria on fatness and thinness
Acronym
Elucidation of the mechanism of action of intestinal bacteria on fatness and thinness
Scientific Title
Elucidation of the mechanism of action of intestinal bacteria on fatness and thinness
Scientific Title:Acronym
Elucidation of the mechanism of action of intestinal bacteria on fatness and thinness
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Some types do not lose weight even after participating in a 5-month weight loss program. The difference between the type that loses weight and the type that loses weight is clarified by changes in the intestinal microflora.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare changes in body weight and bacterial flora to compare the differences between the bacteria that have changed and those that were originally present.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Follow a 4-month weight loss program. Collect intestinal microflora before and after.
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
| 90 | years-old | > |
Gender
Female
Key inclusion criteria
1.Healthy women between the age 20 to under 90.
2,those who albe to eat without assistance.
3.those who voluntarily wush to paticipate in the clinical trail and provide written consent.
4.Persons who are approved to participate by the principal investigator.
Key exclusion criteria
People who need assistance
People whose diet and exercise vary greatly and whose rhythm of life is inconsistent
People who are deemed ineligible by the responsible physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | keiko |
| Middle name | |
| Last name | kamachi |
Organization
kagawa nutrition university
Division name
nutrition clinic
Zip code
170-8481
Address
3-24-3,komagoe, toshima,tokyo
TEL
0339186181
kamachi@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | keiko |
| Middle name | |
| Last name | kamachi |
Organization
Kagawa Nutrition University
Division name
Nutriton Clinic
Zip code
170-8481
Address
3-24-3,komagome,tosima,tokyo
TEL
0339186181
Homepage URL
kamachi@eiyo.ac.jp
Sponsor or person
Institute
kagawa Nutrition University
Institute
Department
Personal name
Keiko Kamachi
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa Nutrition University
Address
3-9-21, chiyoda,sakado,saitama
Tel
049-289-6041
kenshien@eiyo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
22K11888
Org. issuing International ID_1
Institute for Science and Technology Policy Research, Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
女子栄養大学 栄養クリニック
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | 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
16
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
| 2023 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 01 | 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 | 04 | Day |
Last modified on
| 2025 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065151
