UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041228
Receipt number R000047070
Scientific Title A clinical study to evaluate the effects of the test food on attenuating fatigue sensation
Date of disclosure of the study information 2021/03/01
Last modified on 2021/07/29 16:22:23

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Basic information

Public title

A clinical study to evaluate the effects of the test food on attenuating fatigue sensation

Acronym

A clinical study to evaluate the effects of the test food on attenuating fatigue sensation

Scientific Title

A clinical study to evaluate the effects of the test food on attenuating fatigue sensation

Scientific Title:Acronym

A clinical study to evaluate the effects of the test food on attenuating fatigue sensation

Region

Japan


Condition

Condition

Healthy volunteers

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of test food on attenuating fatigue sensation

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

VAS(fatigue sensation)

Key secondary outcomes

VAS(eyestrain, sleepiness, shoulder stiffness, dullness or heaviness in the body, motivation), Jikaku-sho shirabe, Pittsburgh Sleep Quality Index, OSA sleep inventory MA version, Karolinska Sleepiness Scale, POMS2 Japanese version, work performance evaluation, cognitive function test, autonomic nervous function evaluation, urinalysis


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

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of test food for 4 weeks - > Washout for 4 weeks -> Intake of placebo for 4 weeks

Interventions/Control_2

Intake of placebo for 4 weeks - > Washout for 4 weeks -> Intake of test food 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

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1) Males and females whose age of 20 years or more and less than 65 years
2) Subjects who perceive fatigue sensation in daily work
3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent

Key exclusion criteria

1) Subjects with serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
2) Subjects with chronic fatigue syndrome (CFS), or subjects deemed to have severe fatigue such as idiopathic chronic fatigue by the investigator
3) Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for recovery from fatigue or nutritional supplements during physical fatigue
4) Subjects who take regularly Foods with Function Claims labeled the effect of attenuating fatigue sensation
5) Subjects who have the possibility of developing allergic symptoms by the test food
6) Female subjects who are pregnant or lactating, or intending to become pregnant during the study
7) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood)
8) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
9) Subjects deemed unsuitable by the investigator

Target sample size

24


Research contact person

Name of lead principal investigator

1st name Ryota
Middle name
Last name Akagi

Organization

Fujicco Co., Ltd.

Division name

R&D Laboratories

Zip code

650-8558

Address

6-13-4, Minatojima-nakamachi, Chuo-ku, Kobe-shi, Hyogo

TEL

078-303-5385

Email

r-akagi@fujicco.co.jp


Public contact

Name of contact person

1st name Tomohiro
Middle name
Last name Sugino

Organization

Soiken Inc.

Division name

R&D Division

Zip code

560-0082

Address

Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka-shi, Osaka

TEL

06-6871-8888

Homepage URL


Email

sugino@soiken.com


Sponsor or person

Institute

Soiken Inc.

Institute

Department

Personal name



Funding Source

Organization

Fujicco 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

IRB of Fukuda Clinic

Address

Shin-Osaka brick building 2F, 1-6- 1 Miyahara, Yodogawa-ku, Osaka-shi, Os aka

Tel

06-6398-0203

Email

fukudaclinicIRB@gmail.com


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

2021 Year 03 Month 01 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

2020 Year 07 Month 18 Day

Date of IRB

2020 Year 07 Month 18 Day

Anticipated trial start date

2020 Year 08 Month 15 Day

Last follow-up date

2020 Year 12 Month 19 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 07 Month 28 Day

Last modified on

2021 Year 07 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047070


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name