UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038471 |
|---|---|
| Receipt number | R000043824 |
| Scientific Title | A study of the influence of using oil on dietary pattern and nutrition. |
| Date of disclosure of the study information | 2019/11/02 |
| Last modified on | 2023/12/05 17:59:14 |
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Basic information
Public title
A study of the influence of using oil on dietary pattern and nutrition.
Acronym
Influence of using oil on dietary pattern and nutrition.
Scientific Title
A study of the influence of using oil on dietary pattern and nutrition.
Scientific Title:Acronym
Influence of using oil on dietary pattern and nutrition.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the influence of using oil on dietary pattern and nutrition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of fatty acids intake
Key secondary outcomes
Changes of dietary pattern
Nutrient intake
Anthropometric examination
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
-Dietary records for 3 days every two weeks (total 9 days).
Interventions/Control_2
-Dietary records for 3 days every two weeks (total 9 days).
-Intake of test oil with meal for 4 weeks
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy males and females
Key exclusion criteria
1) Subjects who have food allergy.
2) Subjects who are unable to participate in the study because of serious diseases.
3) Subjects whose BMI is less than 18.5.
4) Pregnant and lactating women.
5) Subjects who don't agree to the purpose and contents of this study.
6) Subjects who are judged unsuitable for participating in this study by principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Azumi |
| Middle name | |
| Last name | Hida |
Organization
Tokyo University of Agriculture
Division name
Department of Nutritional Science
Zip code
156-8502
Address
1-1-1, Sakuragaoka, Setagaya, Tokyo, 156-8502 Japan
TEL
+81-(0)3-5477-2378
a3hida@nodai.ac.jp
Public contact
Name of contact person
| 1st name | Azumi |
| Middle name | |
| Last name | Hida |
Organization
Tokyo University of Agriculture
Division name
Department of Nutritional Science
Zip code
156-8502
Address
1-1-1, Sakuragaoka, Setagaya, Tokyo, 156-8502 Japan
TEL
+81-(0)3-5477-2378
Homepage URL
a3hida@nodai.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture
Department of Nutritional Science
1-1-1, Sakuragaoka, Setagaya, Tokyo, 156-8502 Japan
Institute
Department
Personal name
Funding Source
Organization
Kao 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
Tokyo University of Agriculture, IRB
Address
1-1-1, Sakuragaoka, Setagaya, Tokyo, 156-8502 Japan
Tel
+81-(0)3-5477-2532
nri@nodai.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
| 2019 | Year | 11 | Month | 02 | 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
43
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
| 2019 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 08 | 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
| 2019 | Year | 11 | Month | 01 | Day |
Last modified on
| 2023 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043824
| 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 |
