UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058403 |
|---|---|
| Receipt number | R000066768 |
| Scientific Title | Carotid artery wall thickness and physical measurements and nutritional intake in young women |
| Date of disclosure of the study information | 2025/07/10 |
| Last modified on | 2025/07/08 16:12:32 |
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Basic information
Public title
Carotid artery wall thickness and physical measurements and nutritional intake in young women
Acronym
Carotid artery wall thickness and physical measurements and nutritional intake in young women
Scientific Title
Carotid artery wall thickness and physical measurements and nutritional intake in young women
Scientific Title:Acronym
Carotid artery wall thickness and physical measurements and nutritional intake in young women
Region
| Japan |
Condition
Condition
lifestyle disease
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The subjects were young and middle-aged women.They will be asked to directly measure the vascular status of the carotid artery wall and to write physical measurements, blood tests, urinalysis, and a 3-day dietary record.We will compare the age at which atherosclerosis, an indicator of lifestyle-related diseases, begins to occur.
Basic objectives2
Others
Basic objectives -Others
To examine the relationship between the development of atherosclerosis and diet (nutrients) by observing the relationship between diet and the vascular status of the carotid artery wall.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Using carotid artery echocardiography, the relationship between carotid intima-media complex (IMT) thickness and nutritional value derived from biochemical laboratory values and dietary records will be compared in young and middle-aged women.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
For young women, carotid echocardiography will be performed on college students 18-30 years of age.Physical measurements, blood tests, and a written 3-day dietary record will be taken.
Interventions/Control_2
For middle-aged and older women, carotid artery echocardiography will be performed in subjects between 40 and 85 years of age.Physical measurements, blood tests, and a written 3-day dietary record will be taken.
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Healthy individuals with no serious diseases.
2.Women between the ages of 18 and 75 who voluntarily wish to participate in the clinical trial and provide written consent.
3.Those who are able to maintain a certain daily lifestyle during the study period.
4.Those who are being treated for mild chronic diseases (hypertension, hyperlipidemia, etc.) may participate in the study at the discretion of the study investigator.
Key exclusion criteria
1)Patients with serious diseases (cardiac, hepatic, renal, cancer, etc.) or mental disorders
2)Those with a history of digestive system diseases or digestive organ surgeries
3)Those who are unable to maintain their daily lifestyle with significant changes in diet and physical activity
4)Pregnant or lactating women and those who wish to become pregnant during the study period
5)Other patients who are deemed ineligible by the investigator to participate in this study.
6)Those who have participated in other clinical trials within the past month.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Ishihara |
Organization
Kagawa Nutrition University
Division name
Nutrition Clinic
Zip code
1708481
Address
3-24-3,Komagome,Toshima-ku,Tokyo.
TEL
0339186181
clinic@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Kamachi |
Organization
Kagawa Nutrition University
Division name
Nutrition Clinic
Zip code
1708481
Address
3-24-3,Komagome,Toshima-ku,Tokyo.
TEL
0339186181
Homepage URL
clinic@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
Kagawa Nutrition University
Organization
Division
Category of Funding Organization
Self funding
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-shi,Saitama
Tel
0492832131
clinic@eiyo.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
| 2025 | Year | 07 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2030 | 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 | 07 | Month | 08 | Day |
Last modified on
| 2025 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066768
