UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029230
Receipt number R000033182
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.
Date of disclosure of the study information 2018/12/15
Last modified on 2019/09/25 15:01:13

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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 or person

Institute

KSO Corporation

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033182


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name