UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052515 |
|---|---|
| Receipt number | R000059929 |
| Scientific Title | Experimental study of the effects of food on the in-vivo dynamics and physical function of aging-related substances. |
| Date of disclosure of the study information | 2023/10/17 |
| Last modified on | 2024/04/17 09:52:49 |
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Basic information
Public title
Experimental study of the effects of food on the in-vivo dynamics and physical function of aging-related substances.
Acronym
Experimental study of the effects of food on the in-vivo dynamics and physical function of aging-related substances.
Scientific Title
Experimental study of the effects of food on the in-vivo dynamics and physical function of aging-related substances.
Scientific Title:Acronym
Experimental study of the effects of food on the in-vivo dynamics and physical function of aging-related substances.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory evaluation of effect of a light exercise or test food intake on in vivo dynamics of aging-related substances and body composition and physical function parameters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood ANGPTL2
Fasting blood glucose level
Blood HbA1c
Key secondary outcomes
Skin image analysis
Physical examination (height, weight, body fat, muscle mass, etc.)
Physical function (walking speed, stride length, calf circumference, standing up ability, grip strength)
Saliva test (saliva volume, salivary amylase level)
Capillary Image
Questionnaire (skin, stress, sleep, intestinal environment, exercise habits, etc.)
Sensory receptor sensity (measurement of two-point discrimination)
Olfactory test
Gustatory test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Prevention
Type of intervention
| Food | Other |
Interventions/Control_1
Ingest supplements containing Shiranui chrysanthemum daily for 3 months.
Interventions/Control_2
Ingest supplements containing Shiranui chrysanthemum and test foods 1 daily for 3 months.
Interventions/Control_3
Ingest test foods 1 daily for 3 months.
Interventions/Control_4
Ingest test foods 2 and doing light exercise daily for 3 months.
Interventions/Control_5
No intervention
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Healthy Japanese who are 30 years old
3.Persons with high blood sugar and BMI index
Key exclusion criteria
1.Persons who have chronic illness, receiving medication, have a serious disease history
2.Persons who wear a pacemaker
3.Persons who are allergic to the test food
4.Persons who usually take a large amount of test foods
5.Persons who regularly use medicines, foods for specified health use, health foods, etc. that may affect anti-aging or skin function
6.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
7.Persons who were judged as inappropriate for study participants by the principal investigator
8.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Maji |
Organization
Saishunkan Pharmaceutical co.,ltd
Division name
Research and development department
Zip code
861-2201
Address
1363-1 Jichu Mashiki-machi, Kamimashiki-gun, Kumamoto-ken, Japan
TEL
096-289-4444
d.maji@saishunkan.co.jp
Public contact
Name of contact person
| 1st name | Chisato |
| Middle name | |
| Last name | Furusawa |
Organization
Saishunkan Pharmaceutical co.,ltd
Division name
Research and development department
Zip code
861-2201
Address
1363-1 Jichu Mashiki-machi, Kamimashiki-gun, Kumamoto-ken, Japan
TEL
096-289-4444
Homepage URL
c.furusawa@saishunkan.co.jp
Sponsor or person
Institute
Saishunkan Pharmaceutical co.,ltd
Institute
Department
Personal name
Funding Source
Organization
Saishunkan Pharmaceutical co.,ltd
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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
052-734-8885
soumu@hc-sys.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
| 2023 | Year | 10 | Month | 17 | 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
107
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
Completed
Date of protocol fixation
| 2023 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 10 | Month | 17 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059929
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
