UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the impact of PF on daily discomfort and work productivity in healthy adult employee: A randomized, double-blind , placebo-controlled, cross-over study.
Acronym	The efficacy of the test food on daily discomfort and work productivity
Scientific Title	Examination of the impact of PF on daily discomfort and work productivity in healthy adult employee: A randomized, double-blind , placebo-controlled, cross-over study.
Scientific Title:Acronym	The efficacy of the test food on daily discomfort and work productivity
Region	Japan

Condition
Condition	None
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of the test food on daily discomfort and work productivity in healthy adults
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	QOL index, Work productivity, Fatigue index, Daily discomfort
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of test food for a week, then int ake of placebo for a week after 3-wee k wash out period.
Interventions/Control_2	Intake of placebo for a week, then inta ke of test food for a week after 3-wee k wash out period.
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) healthy workers between 20-65 years of age 2) subjects who are off on weekends 3) subjects who recognize daily discomfort
Key exclusion criteria	1) subjects who have allergy to medicinal and foods. 2) subjects who have a severe past medical history, acute infection, or mental disorder. 3) subjects who will have stressful situation in the intake periods. 4) subjects who smoke more than 20 cigarettes a day. 5) subjects who take alcohol nearly every day. 6) subjects who take much caffeine rich drink. 7) shift wokers and graveyard shift. 8) subjects who routinely take medicin, supplements, FOSHU, and/or healt h food which affect to the result of the study. 9) subjects who are estimated inappropriate to participate to this study by principal investigator.
Target sample size	44

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshitaka Iwama
Organization	Nihonbashi Cardiology Clinic
Division name	Director
Zip code
Address	It's common number 4 number 13, Nihonbashikodenmacho, Chuo-ku, Toky
TEL	03-5641-4133
Email	yiwama@well-sleep.jp

Public contact
Name of contact person	1st name Middle name Last name Yoshika Komori
Organization	KSO Corporation
Division name	Sales department
Zip code
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Co.,Ltd.
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
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

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 15 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	2017 Year 09 Month 21 Day
Date of IRB	2017 Year 09 Month 15 Day
Anticipated trial start date	2017 Year 09 Month 23 Day
Last follow-up date	2017 Year 12 Month 15 Day
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 21 Day
Last modified on	2019 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033182