UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054095 |
|---|---|
| Receipt number | R000061776 |
| Scientific Title | Verification of the effectiveness of dietary guidance methods using two biological indexes of diet |
| Date of disclosure of the study information | 2024/04/20 |
| Last modified on | 2025/04/10 18:07:17 |
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Basic information
Public title
Verification of the effectiveness of dietary guidance methods using two biological indexes of diet
Acronym
Verification of the effectiveness of dietary guidance methods using two biological indexes of diet
Scientific Title
Verification of the effectiveness of dietary guidance methods using two biological indexes of diet
Scientific Title:Acronym
Verification of the effectiveness of dietary guidance methods using two biological indexes of diet
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of dietary guidance based on two biometric indicators of diet and its combination with vegetable beverage provision on dietary behavior change.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
4-week change in the measured value of biological index A
Key secondary outcomes
4-week change in biometric index B, blood pressure (systolic and diastolic), and behavior modification level of diet
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Other |
Interventions/Control_1
Measurements using two biological indicators of diet
Interventions/Control_2
Dietary guidance using two biological indicators of diet
Interventions/Control_3
Dietary guidance and vegetable beverage provision using two biological indicators of diet
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Male and female over 20 years old
Key exclusion criteria
(1) Persons with food allergies to the test foods.
(2) Persons with potassium intake restrictions.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Ushida |
Organization
KAGOME CO., LTD.
Division name
Diet & Well-being Research Institute
Zip code
329-2762
Address
17, Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
Yusuke_Ushida@kagome.co.jp
Public contact
Name of contact person
| 1st name | Hina |
| Middle name | |
| Last name | Kitagawa |
Organization
KAGOME CO., LTD.
Division name
Diet & Well-being Research Institute
Zip code
329-2762
Address
17, Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
Homepage URL
Hina_Kitagawa@kagome.co.jp
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Suwa Chuo Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suwa Chuo Hospital
Address
4300 Tamagawa, Chino-shi, Nagano
Tel
0266-72-1000
jimubu@suwachuo.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2024-R03
Org. issuing International ID_1
Research Ethics Review Committee, Kagome Co.
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
諏訪中央病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 20 | 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
53
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 | 09 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 15 | Day |
Date trial data considered complete
| 2024 | Year | 05 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 09 | Day |
Last modified on
| 2025 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061776
