UMIN-CTR Clinical Trial

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
Email	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
Email	yajimamarch@yahoo.co.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033140