UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053422 |
|---|---|
| Receipt number | R000046981 |
| Scientific Title | Effect of dietary improvement program on metabolic syndrome index and behavior. |
| Date of disclosure of the study information | 2024/01/24 |
| Last modified on | 2024/01/24 10:57:01 |
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Basic information
Public title
Effect of dietary improvement program on metabolic syndrome index and behavior.
Acronym
Effect of dietary improvement program on metabolic syndrome index and behavior.
Scientific Title
Effect of dietary improvement program on metabolic syndrome index and behavior.
Scientific Title:Acronym
Effect of dietary improvement program on metabolic syndrome index and behavior.
Region
| Japan | Asia(except Japan) |
Condition
Condition
Persons subject to specific health guidance
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the metabolic syndrome index and behavioral efficacy of a diet improvement program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Abdominal circumference, weight, BMI, body fat percentage, visceral fat area
Key secondary outcomes
Blood chemistry test, blood pressure, dietary survey, questionnaire survey (items regarding behavior change)
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
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Meal improvement program
Interventions/Control_2
No intervention
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
| 35 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Persons who meet the conditions for active support for specific health guidance.
2) Men who are 35 years old or older and 59 years old or younger when consent is obtained.
3) Persons who received a sufficient explanation about the participation in the research, and after having fully understood it, have given their free written consent.
Key exclusion criteria
1) Person who is receiving specific health guidance.
2) Those who are taking medicines that are reported to be effective in fat burning and preventing lifestyle-related diseases.3) Persons with diseases related to physical function.
4) Persons whose dietary rhythm becomes irregular during the test period due to shift work or overseas travel.
5) Those who have medications or diseases that affect eating such as dementia.
6) Those who are restricted in diet due to illness, etc.
7) Allergic to milk and soybeans.
8) Those who participate in the test of ingesting other foods and using drugs, and the test of applying cosmetics and drugs.
9) Persons other than the above who are deemed inappropriate by the person responsible for the examination to be the subject of this examination.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Mine |
Organization
Ajinomoto Co., Inc
Division name
Human health & nutrition group, Institute of food sciences & technologies
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
044-223-4114
tomoyuki_mine@ajinomoto.com
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Ono |
Organization
Ajinomoto Co., Inc
Division name
Human health & nutrition group, Institute of food sciences & technologies
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
044-223-4114
Homepage URL
miho_ono@ajinomoto.com
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Nihonbashi Cardiology Clinic
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel
03-5641-4133
niho-jimucho@well-sleep.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
TKP品川カンファレンスセンター新館(東京都)/
TKP Shinagawa Conference Center New Building (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 24 | 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
70
Results
Results date posted
| 2024 | Year | 01 | Month | 24 | Day |
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
| 2020 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 01 | 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
| 2024 | Year | 01 | Month | 24 | Day |
Last modified on
| 2024 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046981
| Research Plan | |
|---|---|
| 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 |
