UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041221
Receipt number R000047073
Scientific Title A study for the effect of the test food on fatigue caused by stress in daily life
Date of disclosure of the study information 2020/07/31
Last modified on 2022/02/21 08:57:23

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Basic information

Public title

A study for the effect of the test food on fatigue caused by stress in daily life

Acronym

A study for the effect of the test food on fatigue caused by stress in daily life

Scientific Title

A study for the effect of the test food on fatigue caused by stress in daily life

Scientific Title:Acronym

A study for the effect of the test food on fatigue caused by stress in daily life

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 effect of test food on fatigue caused by stress in daily life

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

-Fatigue sensation
-Autonomic nervous function

Key secondary outcomes

-Mood status
-Work performance
-Cognitive function
-Blood analysis


Base

Study type

Interventional


Study design

Basic design

Parallel

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

Interventions/Control_2

Intake of placebo 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 answer the questionnaire that they have fatigue sensation in daily life
3)Subjects deemed fatigued based on their scores of VAS and Face scale at the screening
4)Subjects who work in the office
5)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 receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
2)Subjects having the 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 take regularly supplements of amino acids or proteins
6)Subjects who are heavy drinkers (>=60 g per day as pure alcohol)
7)BMI <18.5 kg/m2 and >=30 kg/m2
8)Subjects who have the possibility of primary diseases in autonomic nervous system
9)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)
10)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
11)Female subjects who are pregnant or lactating, or intending to become pregnant during the study
12)Subjects deemed unsuitable by the investigator

Target sample size

48


Research contact person

Name of lead principal investigator

1st name Tomoyuki
Middle name
Last name Mine

Organization

Ajinomoto Co., Inc.

Division name

Institute of Food Sciences and Technologies

Zip code

2108681

Address

1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa

TEL

044-223-4114

Email

tomoyuki_mine@ajinomoto.com


Public contact

Name of contact person

1st name Daichi
Middle name
Last name Shindo

Organization

Ajinomoto Co., Inc.

Division name

Institute of Food Sciences and Technologies

Zip code

2108681

Address

1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa

TEL

044-223-4114

Homepage URL


Email

daichi_shindo@ajinomoto.com


Sponsor or person

Institute

Soiken Inc.

Institute

Department

Personal name



Funding Source

Organization

Ajinomoto Co., Inc.

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, Osaka

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

2020 Year 07 Month 31 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 03 Month 21 Day

Anticipated trial start date

2020 Year 08 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 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 27 Day

Last modified on

2022 Year 02 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047073


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name