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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038471
Receipt No. 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 2019/11/01

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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
30 years-old <=
Age-upper limit
65 years-old >=
Gender Male
Key inclusion criteria Healthy males
Key exclusion criteria 1) Subjects who have food allergy.
2) Subjects who are unable to participate in the study because of serious diseases.
3) Heavy drinker and smoker.
4) Subjects whose BMI is less than 18.5.
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
Email 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
Email a3hida@nodai.ac.jp

Sponsor
Institute Tokyo University of Agriculture
Department of Nutritional Science
1-1-1, Sakuragaoka, Setagaya, Tokyo, 156-8502 Japan
Institute
Department

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
Email 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
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
2021 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
2019 Year 11 Month 01 Day
Last modified on
2019 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043824

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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