UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028960 |
|---|---|
| Receipt number | R000033140 |
| Scientific Title | The effect of ingesting fatty acid intervention on energy metabolism and sleep |
| Date of disclosure of the study information | 2017/09/06 |
| Last modified on | 2021/08/18 17:30:11 |
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Basic information
Public title
The effect of ingesting fatty acid intervention on energy metabolism and sleep
Acronym
Metabolism and sleep after intervention of different fatty acids
Scientific Title
The effect of ingesting fatty acid intervention on energy metabolism and sleep
Scientific Title:Acronym
Metabolism and sleep after intervention of different fatty acids
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of ingestion of different fatty acids on metabolism and sleep
Basic objectives2
Others
Basic objectives -Others
To evaluate the effect of ingestion of different fatty acids on metabolism and sleep
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
energy metabolism and sleep
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake a diet rich in long chain saturated fatty acids
Interventions/Control_2
Intake a diet rich in monounsaturated fatty acids
Interventions/Control_3
Intake a diet rich in polyunsaturated fatty acids
Interventions/Control_4
Intake a diet rich in middle chain saturated fatty acids
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
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
Good sleeper
Healthy young male
Key exclusion criteria
Smoker
Shift worker
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kumpei Tokuyama |
Organization
University of Tsukuba
Division name
Doctoral Program in Sports Medicine
Zip code
Address
Tennodai 1-1-1, Tsukuba, Ibaraki
TEL
029-853-5643
tokuyama@taiiku.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhiko Yajima |
Organization
University of Tsukuba
Division name
Doctoral Program in Sports Medicine
Zip code
Address
Tennodai 1-1-1, Tsukuba, Ibaraki
TEL
090-2162-1659
Homepage URL
yajimamarch@yahoo.co.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
筑波大学
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 06 | 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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 01 | Day |
Last modified on
| 2021 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033140
| 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 |
