UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058487 |
|---|---|
| Receipt number | R000066866 |
| Scientific Title | A study to investigate the factors related to changes in abdominal skeletal muscle mass and quality in women |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2025/07/16 10:30:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study to investigate the factors related to changes in abdominal skeletal muscle mass and quality in women
Acronym
A study to investigate the factors related to changes in abdominal skeletal muscle mass and quality in women
Scientific Title
A study to investigate the factors related to changes in abdominal skeletal muscle mass and quality in women
Scientific Title:Acronym
A study to investigate the factors related to changes in abdominal skeletal muscle mass and quality in women
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the factors related to changes in abdominal skeletal muscle mass and quality by the cross-sectional study.
Basic objectives2
Others
Basic objectives -Others
Investigation of the factors related to changes in abdominal skeletal muscle mass and quality by the cross-sectional study.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Abdominal muscle thickness
Key secondary outcomes
Abdominal muscle echo intensity, body composition, index of posture
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
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Subjects who are women aged 20 to 79
2.Subjects who do not have any serious illnesses (malignant tumors, heart disease, neurological disorders, etc.)
3.Subjects who are aware of getting increase of fat and worse of muscles in abdomen
4.Subjects with a BMI ranging from 18.5 to less than 25.0
5.Subjects who live their daily lives without physical assistance
Key exclusion criteria
1.Subjects who receive treatment for diabetes
2.Subjects with past surgical history involving laparotomy or a history of trauma in the trunk(excluding cesarean section)
3.Subjects with surgical history or a plan of total hip arthroplasty
4.Subjects with a history of neuromuscular or musculoskeletal disorders
5.Subjects with a history of malignant tumors
6.Subjects who feel chronic pain in lower back, pelvis, or lower extremities that interferes with their daily lives (including intervertebral disc herniation)
7.Subjects who regularly engage in resistance training or endurance exercises (e.g., jogging, stationary cycling, swimming)
8.Subjects who regularly attend fitness facilities, including yoga or pilates classes
9.Subjects who are currently pregnant
10.Subjects who have participated in clinical trials with exercises within the past year, or clinical trials with intake of pharmaceuticals or food ingredients within the past three month
11.Subjects who are judged as unsuitable for participation by doctors in other reasons
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Machida |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
270-1695
Address
1-1 Hirakagakuendai, Inzai, Chiba 270-1695, Japan
TEL
0476-98-1001
machidas@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shuichi |
| Middle name | |
| Last name | Machida |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
270-1695
Address
1-1 Hirakagakuendai, Inzai, Chiba 270-1695, Japan
TEL
0476-98-1001
Homepage URL
machidas@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
KANEKA CORPORATION
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
Ethics committee in Juntendo University Graduate School of Health and Sports Science
Address
1-1 Hirakagakuendai, Inzai, Chiba 270-1695, Japan
Tel
0476-98-1001
sc-rinri@juntendo.ac.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 | 04 | Month | 01 | 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 | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 07 | Month | 16 | Day |
Last modified on
| 2025 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066866
